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Now offering:  Phase I & Pharmacokinetic Unit

Synopsis of Completed and Current Studies

Diabetes - Type 2

2008 PI - Ronald Brazg, MD (Phase 2a)
A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of an investigational medication in Combination with Sitagliptin or in Combination with Metformin in Patients with Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control
 
2008 PI - Leslie Klaff, MD, Ph D (Phase 2)
The Effect of Dose Titration of an investigational medication in Overweight and Obese Patients with Type 2 Diabetes Mellitus
 
2008 PI - Ronald Brazg, MD (Phase 3)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter 12-Week Study Assessing the Efficacy and Safety of an investigational medication in Drug Naive Patients with Type 2 Diabetes
 
2008 PI - Leslie Klaff, MD, Ph D (Phase 3)
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of an investigational medication at two Doses for 24 Weeks Treatment on the rate of Regeneration of Epidermal Nerve Fibers in Patients with Mild Diabetic Peripheral Neuropathy
 
2008 PI - Leslie Klaff, MD, Ph D (Phase 3)
A Randomized, Double-Blind, Active-Controlled Parallel Group Efficacy and Safety Study of an investigational medication (5.0 mg administered orally once daily) compared to glimperiride ( 1 to 4 mg once daily) over two years, in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy
 
2007 PI - Allen Sussman, MD (Phase 3)
A 16-Week Randomized, Open Labelled, Four-Armed, Treat-to-Target, Parallel-Group Trial Comparing Three Different Dosing Levels of An Investigational Insulin and Insulin Glargine Once Daily, All in Combination with Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment
 
2007 PI - Ronald Brazg, MD (Phase 2b)
A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of an Investigational Medication in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control.
 
2007 PI - Allen Sussman, MD (Phase 3)
A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for An Investigational Inhaled Insulin in Insulin-Naοve Patients with Type 2 Diabetes Mellitus.
 
2007 - PI- Leslie Klaff, MD, Ph.D (Phase 3)
An Open Label, Multicenter, Randomized, Parallel Group Study Comparing the Efficacy and Safety of an Investigational Insulin and Regular Human Insulin in Patients with Type 2 Diabetes Mellitus.
 
2007 - PI – Ronald Brazg, MD (Phase 3a)
Inhaled Mealtime Insulin with the AERx iDMS Plus Metformin & Glimepiride versus Rosiglitazone Plus Metformin & Glimepiride in Type 2 Diabetes: A 26-Week, Open Label, Multicentre, Randomized, Parallel Trial to Investigate Safety and Efficacy.
 
2006 - PI – Allen Sussman, MD (Phase 3A)
A Prospective, Multicenter, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects with Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of An Investigational Insulin Vs. Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 24-Week Follow Up.
 
2006 - PI – Allen Sussman, MD (Phase 2)
A Pilot Study of the Efficacy and Safety of an Investigational Medication on Glycemic Control in Subjects with Type 2 Diabetes Treated Aggressively but not Controlled on Combination Antihyperglycemic Therapy with Metformin and/or Thiazolidinedione (TZD) and Insulin.
 
2006 - PI – Allen Sussman, MD (Phase IIIa)
Liraglutide Effect and Action in Diabetes (Lead 3): Effect on Glycemic Control of Liraglutide versus Glimepiride in Type 2 Diabetes [A Fifty-Two Week (with Fifty-Two Week Open-Label Extension), Double-Blinded, Multicenter, Randomized, Parallel Study to Investigate Safety and Efficacy]
 
2006 - PI- Leslie Klaff, MD, Ph.D
The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine when added to Existing Oral Therapy in Patients with Type 2 Diabetes and Inadequate Glycemic Control.
 
2006 - PI- Ronald Brazg, MD (Phase III)
A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients with Type 2 Diabetes Mellitus who have Inadequate Glycemic Control on Combination Therapy with Metformin and a PPAR? Agonist
 
2006 - PI – Allen Sussman, MD (Phase IIIb)
A Phase 3b, randomized, open-label, parallel group, multicenter trail assessing the efficacy of Exubera vs Lispro introduced into a Lantus based regimen in ssub optimallycontrolled patients with Type 2 Diabetes Mellitus
 
2006 - PI- Ronald Brazg, MD (Phase IIa/b)
An Efficacy and Tolerability study An Investigational Medication in Patients with Type 2 Diabetes Mellitus who have Inadequate Glycemic Control
 
2006 - PI- Leslie Klaff, MD, Ph.D (Phase IIb)
A randomized, double-blinded, placebo-controlled, five parallel group study investigating the efficacy and safety of An Investigational Medication (0.5 mg, 2.5 mg and 5.0 mg administered orally once daily) over 12 weeks in drug naοve and treated patients with Type 2 diabetes with insufficient glycemic control ( study includes an open-label metformin treatment arm)
 
2006 – PI – Ronald Brazg, MD (Phase III)
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallen-Group, Fixed-Dose Study Evaluating the Effect of One Dose of An Investigational Medication (20 mg/day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled with Insulin
 
2006 –PI – Allen Sussman, MD (Phase II)
A Multi-Center, Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability and Pharmocokinetics of An Investigational Medication in Patients With Type 2 Diabetes Mellitus
 
2005 –PI – Allen Sussman, MD (Phase IIIa)
Primary Outcomes Within a 2-Year Period In Subjects With Diabetes Mellitus Treated with An Inhaled Investigational Medication or Usual Antidiabetic Treatment and In Subjects With Abnormalities in Glucose Control
 
2005 – PI – Leslie Klaff, MD, Ph.D. (Phase IIIb)
A Phase 3B Randomized, Open-Label, Comparator Controlled, Multicenter Study to Evaluate the Metabolic Effect of A Marketed Drug, Rosiglitazone, and A Marketed Drug Plus Rosiglitazone in Subjects with Type 2 Diabetes Mellitus Treated with Metformin
 
2005 – PI – Ronald Brazg, MD (Phase III)
A Study to Assess the Efficacy and Tolerability of An Investigational Medication Co-Administered with Insulin in Patients with Type 2 Diabetes
 
2005 – PI – Ronald Brazg, MD (Phase III)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of An Investigational Medication to Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination with Metformin
 
2005 – PI – Ronald Brazg, MD (Phase IIIb)
A 26 Week, Multi-center, Open-label, Parallel, 2:1 Randomized Treat-to-Target Trial Comparing Efficacy and Safety of an investigational medication Versus Insulin Glargine using a Basal-Bolus Regimen with Insulin Aspart as Mealtime Insulin in Subjects with Type 2 Diabetes
 
2005 –PI – Allen Sussman, MD (Phase IIb)
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 26-Week Dose-Response Study of an investigational medication with Active Comparator in Subjects with Type 2 Diabetes
 
2004 – PI – Ronald Brazg, MD (Phase III)
A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of an investigational medication Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
 
2004 – PI – Leslie Klaff, MD, PhD (Phase III)
Standard Training versus Intensive Training for an investigational medication and device in Insulin-Naοve Patients with Type 2 Diabetes Mellitus
 
2004 – PI – Ronald Brazg, MD. (Phase IIa)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of an investigational medication Monotherapy in Patients with Type 2 Diabetes Mellitus and Metabolic Syndrome
 
2004 – PI – Ronald Brazg, MD (Phase III)
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of an investigational medication to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy
 
2004 – PI – Ronald Brazg, MD (Phase III)
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of an investigational medication to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
 
2004 – PI – Ronald Brazg, MD (Phase III)
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of an investigational medication to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
 
2004 – PI – Allen Sussman, MD (Phase III)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of an investigation medication in Type 2 Diabetics with Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination with Other Oral Anti-Diabetic Agents
 
2004 – PI – Allen Sussman, MD (Phase IIIb)
A Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of an investigational medication in Combination with Metformin and Pioglitazone to Metformin and Pioglitazone Alone in Insulin Naοve Subjects with Type 2 Diabetes
 
2004 – PI – Leslie Klaff, MD, PhD (Phase II)
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study of the Efficacy, Safety, and Tolerability of Pioglitazone HCL (Actos) in Combination With an investigational medication in Subjects With Type 2 Diabetes
 
2004 – PI Allen Sussman (Phase III)
A 24-Week Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of an investigational Therapy When Added to Therapy of Patients with Type 2 Diabetes
 
2004 – PI – Allen Sussman (Phase III)
A Randomized, Double-Blind, Placebo-Controlled Trial to Assess Safety and Tolerability during Treatment of Type 2 Diabetes with Usual Diabetes Therapy and either investigational medication or Placebo
 
2004 –PI – Leslie Klaff, MD, PhD (Phase IV)
Effects of Mixture Therapies on the Overall Glycemic Control of Patients with Type 2 Diabetes: A Comparison of an investigational medication to Once-Daily Insulin Glargine Plus Lispro
 
2004 –PI – Leslie Klaff, MD, PhD (Phase IIa)
A Placebo Controlled Phase II Study to Evaluate the Efficacy and Safety of Twelve-Week Treatment with Two Different Doses of an investigational medication, in Patients with Type 2 Diabetes Mellitus Treatment With Metformin
 
2004 –PI – Leslie Klaff, MD, PhD (Phase III)
Safety and Efficacy of an investigational medication in Patients with Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
 
2004 – PI – Leslie Klaff, MD, PhD (Phase III)
A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 52 Weeks Treatment with an investigational medication to Metformin up to 1000 mg bid in Drug Naοve Patients with Type II Diabetes.
 
2004 – PI – Ronald Brazg, MD (Phase II)
A Phase II Dose-Range Finding Study of an investigational medication in patients with Type 2 Diabetes.
 
2003 – PI – Ronald Brazg, MD (Phase IIa)
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, cross-over Study With an investigational medication in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin
 
2003 – PI – Ronald Brazg, MD (Phase III)
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of an investigational medication in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
 
2003 – PI – Leslie Klaff, MD, Ph.D (Phase IV)
Long-Term Effects of Insulin plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients with Type 2 Diabetes: A Comparison of Premeal investigational insulin to a Once-Daily Insulin Glargine
 
2003 – PI – Allen Sussman, MD (Phase III)
A Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Trial of an investigational medication for Glycemic Control in Patients With Diabetes Mellitus Type 2 With and Without Metformin
 
2003 – PI – Ronald Brazg, MD (Phase III)
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of an investigational medication Added to Insulin in Patients With Inadequately Controlled Type 2 Diabetes Mellitus
 
2003 –PI – Allen Sussman, MD (Phase III)
A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing an investigational medication vs. Avandia (rosiglitazone maleate) as Add-On Therapy vs. an investigational medication Substitution of Sulfonylurea in Patients with Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment.
 
2003 –PI – Ronald Brazg, MD (Phase IV)
Investigational Medication Titrate-To-Target: An observational study of the efficacy of an investigational medication in patients with Type 2 Diabetes Mellitus not achieving glycemic targets on OADs with/ without once daily basal insulin therapy.
 
2003 – PI – Ronald Brazg, MD (Phase III)
Effect of an investigational medication compared with insulin glargine in patients with Type 2 Diabetes Also Using Combination Therapy with Sulfonylurea and Metformin.
 
2003 – PI – Leslie Klaff, MD, Ph.D (Phase II)
The Efficacy and Safety of an investigational medication for the Treatment of Type 2 Diabetes
 
2003 – PI – Leslie Klaff, MD, Ph.D (Phase III)
An Open-Label Study of the Long Term Safety of an investigational medication Use in Patients with Type 1 or 2 Diabetes Mellitus
 
2003 – PI – Allen Sussman, MD (Phase III)
A Multicenter, Double-Blind, Randomized, Active-Controlled Parallel Study in Patients With Type 2 Diabetes to Evaluate the Cardiac and Metabolic Effects of an investigational medication
 
2003 – PI – Ronald Brazg, MD (Phase III)
A Double-Blind, Randomized, Active-Controlled investigational medication and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise
 
2003 – PI – Ronald Brazg, MD (Phase III)
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of investigational medication to Patients with Type 2 Diabetes with Inadequate Glycemic Control on Metformin and Sulfonylurea Therapy in Combination with Simvastatin.
 
2002 – PI – Leslie Klaff, MD, Ph.D. (Phase IV)
70/30 (biphasic insulin aspart 70/30) bid vs. (insulin glargine) : A Multicenter, Randomized, Open-Label, Parallel Group Study in Subjects with type 2 Diabetes Inadequately Treated with OAD therapy
 
2002 –PI – Leslie Klaff, MD, Ph.D. (Phase III)
A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of an investigational medication Given Two Times a Day in Subjects with Type 2 Diabetes Mellitus Treated With Metformin Alone
 
2002 –PI – Leslie Klaff, MD, Ph.D. (Phase III)
A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of an investigational medication Given Two Times a Day in Subjects with Type 2 Diabetes Mellitus Treated With Sulfonylurea Alone
 
2002 –PI – Allen Sussman, MD (Phase III)
Efficacy and Safety of an investigational medication Compared with Subcutaneous Human Insulin Therapy in Adult Subjects with Type 2 Diabetes Mellitus: A Two-year, Outpatient, Open-Label, Parallel-Group Comparative Trial
 
2002 –PI – Allen Sussman, MD (Phase II)
Dose Finding, Efficacy, and Safety of an investigational medication in Subjects with Type 2 Diabetes.
 
2002 PI - Ronald Brazg, MD.
A Randomized, double-blind, dose ranging, dose comparison-controlled trial to determine the safety and efficacy of an investigational medication in subjects with Type 2 Diabetes.
 
2002 PI - Leslie Klaff MD.
A study comparing safety and efficacy of three doses of an infused investigational medication to placebo given by continuous subcutaneous infusion in combination with Metformin and Sulfonylurea over 12 weeks in patients with Type 2 Diabetes Mellitus.
 
2001 PI - Leslie Klaff MD.
26 week, multinational, multicenter, controlled, open, 1:1 randomized, parallel clinical trial comparing investigational insulin with regular human insulin injected subcutaneously in subjects with Type 2 diabetes mellitus also using NPH insulin, and which will lead into a comparative 26 - week safety extension study.
 
2001 PI - Leslie Klaff MD.
Evaluation of diabetic retinopathy progression in subjects with type 2 diabetes mellitus treated with insulin.
 
2001 PI - Leslie Klaff MD.
Multicenter, Randomized, Double-Blind, Active Controlled Trial to compare the efficacy and safety of 104 weeks of nateglinide plus metformin vs. glyburide plus metformin in drug naοve subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.
 
2001 PI - Ronald Brazg MD.
A multicenter, double-blind, randomized, placebo- and active-controlled, parallel study to evaluate the glucose and lipid-altering efficacy and safety of an investigational oral medication in patients with Type 2 Diabetes.
 
2001 PI - Ronald Brazg MD.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of an Investigational Medication in Type 2 Diabetic Patients
 
2001 PI - Allen Sussman MD.
Double-Blind, Randomized, Parallel Group Clinical Trial to Compare the Efficacy, Safety, and Tolerability of An Investigation Medication and Metformin Immediate Release Tablets in the Treatment of Type 2 Diabetes Mellitus
 
2001 PI - Leslie Klaff, MD., PhD.
Repaglinide vs. Nateglinide in Combination with Metformin: Comparative Efficacy and Safety: An Open Label, Randomized, Parallel Group, Multi-Center Study In the Treatment of Patients With Type 2 Diabetes Inadequately Controlled with Sulfonylurea or Metformin Monotherapy or Low-Dose Glucovance
 
2001 PI - Ronald Brazg, MD.
A 12-Week, Double Blind, Randomized, Placebo-Controlled, Multicenter Study of An Investigational Medication on Glucose Control In Patients with Type 2 Diabetes Mellitus Not Optimally Controlled on a Sulfonylurea
 
2001 PI - Ronald Brazg, MD.
A Double-Blind, Randomized Study to Evaluate the Effect of An investigational Medication in Subjects With Type 2 diabetes Mellitus Who Have Inadequate Glycemic Control On Half-Maximum to Maximum of the Labeled Doses of Sulfonylurea Monotherapy
 
2001 PI - Leslie Klaff, MD, Ph.D
A Comparison of Safety and Efficacy of An Investigational Insulin B.I.D. Injected Before vs. After Meals: A Multicenter, Randomized, Open-Label, cross-Over Design Study In Elderly Insulin-Treated Subjects With Type 2 Diabetes
 
2001 PI - Allen Sussman, MD
Combination Therapy of Metformin With Once-Daily Evening Dose of An Investigational Insulin or Human Insulin NPH: Comparison of Safety and Efficacy in Subjects with Type 2 Diabetes Previously Inadequately Controlled With Monotherapy or Oral Combination Therapy With Metformin – A Randomized, Six-Month, Open-Label, Parallel Design Multicenter Trial
 
2000 PI - Ronald Brazg, MD
A Multicenter, Randomized, Open-Label, cross-over Trial in Insulin-Requiring (Type 1 and Type 2) Patients with Diabetes, Comparing the Injections With An Investigational Insulin Dosed With A Disposable Pen Delivery Device and Injections with Vial and Syringe
 
2000 PI - Allen Sussman, MD
A Dose-Finding, Efficacy, Safety and Pharmacokinetics of An Investigational Medication In Patients With Type 2 Diabetes
 
2000 PI - Leslie Klaff, MD, Ph.D
The Safety and Efficacy of An Investigational Medication Versus Rosiglitazone: A One-Year, Randomized, Double Blind, Parallel Group, Active Comparator Study
 
2000 PI - Leslie Klaff, MD, Ph.D
A Phase II Proof of Concept Trial on the Antidiabetic Properties of An Investigational Medication in Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study with Four Parallel Groups
 
2000 PI - Allen Sussman, MD
Efficacy, Dose-Ranging, and Safety for An Investigational Medication in Type 2 Diabetic Subjects Inadequately Controlled on Diet, Metformin, or Sulfonylurea: A 24-Week Double-Blind, Randomized, Placebo-Controlled Study; Phase 2b
 
2000 PI - Leslie Klaff, MD, Ph.D.
A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Rosiglitazone Added on To A Background of An Investigational Medication in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin/Glyburide Therapy
 
2000 PI - Allen Sussman, MD
The Effect of an Investigational Medication on HbA1c levels in Type 2 Diabetic Patients, A Double-Blind, Placebo-Controlled, Randomized, Multicenter Dose-Finding and Dose Frequency Study.
 
2000 PI - Leslie Klaff, MD, Ph.D.
Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia In Insulin Naοve Subjects With Type 2 Diabetes On Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin
 
2000 PI - Ronald Brazg, MD
Repaglinide vs. Pioglitazone vs. the Combination In type 2 Diabetes Patients: A 24-Week, Randomized, Controlled Multicenter Trial
 
1999 PI - Leslie Klaff, MD
A Phase I-II Study of the Safety and Efficacy of Subcutaneous Administration of An Investigational Medication on Fasting Blood Glucose In Subjects With Type 2 Diabetes
 
1999 PI - Leslie Klaff, MD, Ph.D.
A Multicenter, Randomized, Double-Blinded, Parallel-Group, Placebo-Controlled, Clinical Evaluation of an Investigational Medication in Combination with Current Insulin Therapy for 26 Weeks Duration in Subjects with Type 2 Diabetes Mellitus Who are Inadequately Controlled with Insulin Alone
 
1999 PI - Allen Sussman, MD
A Double-Blind, Randomized Study of the Safety and Efficacy of a Combination of Metformin and 45mg of ACTOS (Pioglitazone HCI) Compared to a Combination of Metformin and 30mg of ACTOS (Pioglitazone HCI) in the Treatment of Patients with Type 2 (Non-Insulin Dependent) Diabetes Mellitus
 
1999 PI - Allen Sussman, MD
Efficacy and Safety of Inhaled Compared with Subcutaneous Human Insulin Therapy in Subjects with Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Paralleled Comparative Trial
 
1999 PI - Allen Sussman, MD
Efficacy and Safety of Inhaled Human Insulin Therapy in Subjects with Type 2 Diabetes Mellitus Not Well Controlled with Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial
 
1999 PI - Leslie J. Klaff, MD, Ph.D.
A Phase I-II Study of the Safety and Efficacy of Subcutaneous Administration of an Investigational Medication on Fasting Blood Glucose in Subjects with Type 2 Diabetes
 
1999 PI - Allen Sussman, MD
A 2-year, Randomized, Double-Blind, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of Rosiglitazone Versus Placebo in Combination with Glipizide in Elderly Patients with Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Glipizide Therapy and Who Are Intolerant to Metformin or Have a Contraindication to Metformin
 
1999 PI - Ronald Brazg, MD
A Phase III, Randomized, Double-Blind, Active Control Trial to Evaluate the Safety and Efficacy of a Fixed Combination Metformin/Glyburide Product in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Maximum Dose Sulfonylurea Monotherapy
 
1998 PI – Ronald Brazg, MD
A Double-blind, Placebo-Controlled, Randomized Trial to Determine the Effects of a Range of Doses of Metformin Novel Oral Dose Form (biphasic tablet). Administered Either once or Twice a Day in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise.
 
1998 PI – Leslie J. Klaff, MD, Ph.D.
A Double-blind, Randomized Study of the Effects of a Metformin Novel Oral Dosage Form in Patients with Type 2 Diabetes Who are Currently Treated with Immediate Release Metformin.
 
1998 PI – Allen Sussman, MD
A Randomized, Double-blind, Double-dummy Comparison of Sulfonylurea with a Titrated Dose of and Investigational Medication in Type 2 Diabetic Patients.
 
1997 PI - Ronald Brazg, MD
A Double-blind, Placebo Controlled, Randomized Study of the Safety and Efficacy of a Combination of Insulin and Two Doses of an Investigational Medication in the treatment of Type II Diabetes Mellitus Patients.
 
1997 PI - Ronald Brazg, MD
A Double-blind, Placebo Controlled, Randomized Study of the Safety and Efficacy of a Combination of Sulfonylurea and two doses of an Investigational Medication in the treatment of Type II Diabetes Mellitus Patients.
 
1997 PI - Ronald Brazg, MD
A Double-blind, Placebo Controlled, Randomized Study of the Safety and Efficacy of a Combination of Metformin and an Investigational Medication in the treatment of Type II Diabetes Mellitus Patients.
 
1997 PI - Allen Sussman, MD
A 26 Week, Randomized, Double-blind, Multicenter, Placebo Controlled Study to Evaluate the Safety, Efficacy, and Tolerability of an Investigational Medication When Administered to Type II Diabetes Mellitus Using a Once Daily Dosing Regimen, and to Determine the Therapeutic Equivalence of the Once and Twice Daily Dosing Regimens.
 
1997 PI - Leslie J. Klaff, MD, Ph.D.
A 26 Week Randomized, Double blind, Double-Dummy, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of an Investigational Medication When Administered to Patients with Type II Diabetes Mellitus Who are Inadequately Controlled on a Maintenance Dose of Metformin.
 
1997 PI - Leslie J. Klaff, MD, Ph.D.
A 26 week Randomized, Double-blind, Multicentered, Study to Evaluate the Safety, Efficacy, and Tolerability of an Investigational Medication when administer to patients with Type II Diabetes Mellitus Patients who are inadequately controlled on insulin monotherapy.
 
1997 PI - Ronald Brazg, MD
A Randomized, Double-blind, Placebo-Controlled, Six-Month Safety and Efficacy Trial of an Investigational Medication in Type II Diabetes Mellitus Patients.
 
1996 PI - Ronald Brazg, MD
A Randomized Double-blind, Placebo-Controlled, Six-Month Safety and Efficacy Trial of Investigational Medication in Type II Diabetes Mellitus Patients
 
1996 PI - Leslie Klaff, MD, Ph.D.
A Multicenter, Double-blind, Randomized, Combination Study to Prospectively Evaluate the Safety and Efficacy of Two Oral Fixed Doses of an Investigational Medication Plus Glyburide Compared to Placebo Plus Glyburide in Subjects with Non-Insulin-Dependent Diabetes Mellitus on Sulfonylureas.
 
1996 PI - Leslie Klaff, MD, Ph.D.
An Investigational Medication in Type II Diabetes: a Placebo Controlled, Double-blind, Randomized Six Month Fixed Dose Safety Study.
 
1996 PI - Allen Sussman, MD
A Multi-Center, Double-blind, Placebo-Controlled, Parallel Group Comparison Study to Investigate the Efficacy, Tolerability, and Safety of an Investigational Medication in the Treatment of Patients with Non-Insulin Dependent Diabetes Mellitus (Type II) Inadequately Controlled with Diet and Metformin.
 
1996 PI - Allen Sussman, MD
A 4-Year, Double-blind, Randomized, Placebo-Controlled Study of an Investigational Medication as Secondary Prevention of CHD in Patients with (Type II) Noninsulin- Dependent Diabetes Mellitus.
 
1995-1996 PI - Allen Sussman, MD
Fifty-Two Week, Multicenter, Double-blind, Parallel Group, Placebo-Controlled and an Investigational Medication Dose Ranging Study to Evaluate Glycated Hemoglobin in Patients With Type II Diabetes Mellitus.
 
1995-1996 PI - Ronald Brazg, MD
A 12 week, Double-blind Study of an Investigational Medication Versus Placebo in Noninsulin-dependent Diabetes Mellitus Patients Requiring Insulin.
 
1995-1996 PI - Ronald Brazg, MD
A 20 week, Double-blind, Randomized Study of an Investigational Medication in Patients With Non Insulin Dependent Diabetes.
 
1995-1996 PI - Leslie Klaff, MD
A Placebo-Controlled Safety and Efficacy Study of an Investigational Medication in Patients With Type II Diabetes Mellitus and Overt Diabetic Nephropathy.
 
1995-1996 PI - Ronald Brazg, MD
A Study to Evaluate the Safety and Efficacy of an Investigational Medication in the Treatment of Obese Type II Diabetics Maintained on Oral Hypoglycemic Agents.
 
1994-1995 PI - Allen Sussman, MD
A Multicenter, Double-blind, 26-Week Study Comparing the Efficacy and Safety of an Investigational Medication To Simvastatin in NIDDM Patients With Hyperlipidemia
 
1994-1996 PI - Allen Sussman, MD
A l-Year, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of an Investigational Medication in NIDDM Patients With Hyperlipidemia
 
1993-94 PI - Ronald Brazg, MD
A One Year, Multicenter-Center, Double-blind, Randomized, Parallel Group Comparison Extension Study To Investigate the Long-Term Efficacy, Tolerability and Safety of an Investigational Medication in Three Different Doses in the Treatment of Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) who Have Satisfactorily Completed The Double-blind Treatment Phase of Study
 
1993 PI - Allen Sussman, MD
A Multi-Center, Double-blind, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of an Investigational Medication as Compared to a Fixed Dose of Sulfonylurea, Alone and in Combination With an Investigational Medication, in the Treatment of Patients With Mild Non-Insulin-Dependent Diabetes Mellitus (Type II) Inadequately Controlled With Diet Alone.
 
1993 PI - Allen Sussman, MD
A One-Year, Multicenter, Double-blind, Randomized, Parallel Group Comparison Extension Study to Investigate the Long-Term Efficacy, Tolerability and Safety of an Investigational Medication As Compared to a Fixed Dose of Sulfonylurea, Alone and in Combination With an Investigational Medication, in the Treatment of Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) who Have Satisfactorily Completed The Double-blind Treatment Phase of Study
 
1993 PI - Ronald Brazg, MD
A Multi-Center, Double-blind, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of an Investigational Medication in Three Different Doses in the Treatment of Patients With Non-Insulin-Dependent Diabetes Mellitus (NIDDM) Inadequately Controlled With Maximum Daily Doses of Sulfonylurea and Diet
 
1992-1993 PI - Leslie J. Klaff, MD, Ph.D.
A Multi-Center, Double-blind, Randomized, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of Three Different Doses of an Investigational Medication in Patients With Non-Insulin-Dependent (Type II) Diabetes Mellitus, Treated With Diet Alone
 
1992-1993 PI - Leslie J. Klaff, MD, Ph.D.
Fifty-Six Week Open Label Study to Investigate the Long-Term Safety and Tolerability of an investigational medication in patients with Non-Insulin Dependent (Type II) Diabetes Mellitus, Treated With Diet Alone
 
1992-1993 PI - Leslie J. Klaff, MD, Ph.D
Randomized, Comparative Evaluation Of an investigational medication Combined With Insulin Versus Insulin Combined With Placebo In The Treatment of Patients With Non-Insulin Dependent Diabetes Mellitus.
 
1991-1994 PI - Allen Sussman, M.D.
Randomized, Comparative Evaluation Of The Efficacy and Safety Of an investigational medication Versus Glipizide in Patients With Non-Insulin Dependent Diabetes Mellitus

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