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A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

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ClinicalTrials.gov Identifier: NCT00327015
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : September 25, 2009
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

Condition or disease Intervention/treatment Phase
Diabetes Drug: Saxagliptin Drug: Metformin Drug: Placebo Drug: pioglitazone 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 pioglitazone (rescue medication) added onto their blinded study medication
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study Start Date : May 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Saxagliptin and Metformin (A)
PLUS open-label pioglitazone (as needed as rescue medication)
 Drug: Saxagliptin
Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118

Drug: Metformin
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)

Drug: pioglitazone
Tablets, Oral, 15-45 mg, as needed (12 months LT)
Experimental: Saxagliptin and Metformin (B)
PLUS open-label pioglitazone (as needed as rescue medication)
 Drug: Saxagliptin
Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118

Drug: Metformin
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)

Drug: pioglitazone
Tablets, Oral, 15-45 mg, as needed (12 months LT)
Experimental: Saxagliptin and Placebo (C)
PLUS open-label pioglitazone (as needed as rescue medication)
 Drug: Saxagliptin
Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118

Drug: Placebo
Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)

Drug: pioglitazone
Tablets, Oral, 15-45 mg, as needed (12 months LT)
Active Comparator: Metformin and Placebo (D)
PLUS open-label pioglitazone (as needed as rescue medication)
 Drug: Metformin
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)

Drug: Placebo
Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)

Drug: pioglitazone
Tablets, Oral, 15-45 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, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in A1C at Week 24, adjusted for baseline value.

  2. Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy [ 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, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in FPG at Week 24, adjusted for baseline value.

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in FPG at Week 24, adjusted for baseline value.

  3. Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy [ Time Frame: Week 24 ]
    Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.

  4. Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy [ Time Frame: Week 24 ]
    Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.

  5. Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.

  6. Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.

  7. Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy [ Time Frame: Week 24 ]
    Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.

  8. Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy [ Time Frame: Week 24 ]
    Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.

  9. Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy [ Time Frame: Week 24 ]
    Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone.

  10. Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy [ Time Frame: Week 24 ]
    Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone.


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
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 diabetes
  • Inadequate blood sugar control
  • No current treatment with other medications to lower blood sugar

Exclusion Criteria:

  • Major heart, liver or kidney problems
  • Pregnant or breast feeding
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): NCT00327015


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: NCT00327015    
Other Study ID Numbers: CV181-039
First Posted: May 17, 2006    Key Record Dates
Results First Posted: September 25, 2009
Last Update Posted: April 29, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Pioglitazone
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