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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00295633
Recruitment Status : Completed
First Posted : February 24, 2006
Results First Posted : September 25, 2009
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Saxagliptin Drug: Placebo Drug: pioglitazone Drug: rosiglitazone Drug: metformin Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 565 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in A1C at Week 24, adjusted for baseline value.


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in FPG at Week 24, adjusted for baseline value.

  2. Percentage of Participants Achieving A1c <7% at Week 24 [ Time Frame: Week 24 ]
    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.

  3. 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 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295633


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00295633    
Other Study ID Numbers: CV181-013
First Posted: February 24, 2006    Key Record Dates
Results First Posted: September 25, 2009
Last Update Posted: April 7, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Pioglitazone
Rosiglitazone
Saxagliptin
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action