A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00295633
First received: February 22, 2006
Last updated: August 4, 2010
Last verified: June 2010
  Purpose

The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Saxagliptin
Drug: Placebo
Drug: pioglitazone
Drug: rosiglitazone
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Mean change from baseline in A1C at Week 24, adjusted for baseline value.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Mean change from baseline in FPG at Week 24, adjusted for baseline value.

  • Percentage of Participants Achieving A1c <7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24.

  • Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.


Enrollment: 565
Study Start Date: March 2006
Study Completion Date: October 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin plus open-label TZD (A)

Saxagliptin PLUS pioglitazone OR rosiglitazone

PLUS open-label metformin (as needed as rescue medication)

Drug: Saxagliptin
Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: pioglitazone
Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)
Drug: rosiglitazone
Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)
Drug: metformin
Tablets, Oral, 500-2500 mg, as needed (12 months LT)
Experimental: Saxagliptin plus open-label TZD (B)

Saxagliptin PLUS pioglitazone OR rosiglitazone

PLUS open-label metformin (as needed as rescue medication)

Drug: Saxagliptin
Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: pioglitazone
Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)
Drug: rosiglitazone
Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)
Drug: metformin
Tablets, Oral, 500-2500 mg, as needed (12 months LT)
Placebo Comparator: Placebo plus open-label TZD (C)

Placebo PLUS pioglitazone OR rosiglitazone

PLUS open-label metformin (as needed as rescue medication)

Drug: Placebo
Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)
Drug: pioglitazone
Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)
Drug: rosiglitazone
Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)
Drug: metformin
Tablets, Oral, 500-2500 mg, as needed (12 months LT)

Detailed Description:

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (defined as rescue medication) added onto their blinded study medication

  Eligibility

Ages Eligible for Study:   18 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
  • Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5%
  • Body mass index < = 45kg/m2
  • Fasting C-peptide > = 1 ng/mL

Exclusion Criteria:

  • Symptomatic poorly controlled diabetes
  • Recent cardiac or cerebrovascular event
  • Serum creatinine > = 2.0 mg/dL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295633

  Show 133 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00295633     History of Changes
Other Study ID Numbers: CV181-013
Study First Received: February 22, 2006
Results First Received: August 17, 2009
Last Updated: August 4, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Rosiglitazone
Saxagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014