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

Phase 3

Completed

• Conditions: Diabetes
• Interventions: Drug: Saxagliptin; Drug: Placebo; Drug: Metformin; Drug: pioglitazone

• Registration Number: NCT00327015
• Lead Sponsor: AstraZeneca

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

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-15
• Study First Submitted QC: 2006-05-15
• Study First Posted: 2006-05-17
• Primary Completion: 2007-11
• Study Completion: 2008-12
• Results First Submitted: 2009-08-17
• Results First Submitted QC: 2009-08-17
• Results First Posted: 2009-09-25
• Status Verified: 2015-03
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1306

Inclusion Criteria

• Type 2 diabetes
• Inadequate blood sugar control
• No current treatment with other medications to lower blood sugar

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Exclusion Criteria

• Major heart, liver or kidney problems
• Pregnant or breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saxagliptin and Placebo (C)	Placebo	PLUS open-label pioglitazone (as needed as rescue medication)
Metformin and Placebo (D)	Placebo	PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Metformin (B)	pioglitazone	PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Metformin (A)	Saxagliptin	PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Metformin (A)	Metformin	PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Metformin (A)	pioglitazone	PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Metformin (B)	Saxagliptin	PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Metformin (B)	Metformin	PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Placebo (C)	pioglitazone	PLUS open-label pioglitazone (as needed as rescue medication)
Saxagliptin and Placebo (C)	Saxagliptin	PLUS open-label pioglitazone (as needed as rescue medication)
Metformin and Placebo (D)	Metformin	PLUS open-label pioglitazone (as needed as rescue medication)
Metformin and Placebo (D)	pioglitazone	PLUS open-label pioglitazone (as needed as rescue medication)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Baseline, Week 24	Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Baseline, Week 24	Mean change from baseline in A1C at Week 24, adjusted for baseline value.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Baseline, Week 24	Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Baseline, Week 24	Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	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.
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	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.
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	Baseline, Week 24	Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
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	Baseline, Week 24	Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	Week 24	Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	Week 24	Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy	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.
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy	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.

Trial Locations

Locations (47)

Newark Physician Associates; 🇺🇸 Newark, Ohio, United States

East Bay Clinical Trial Center; 🇺🇸 Concord, California, United States

Community Clinical Trials; 🇺🇸 Orange, California, United States

Coastal Biomedical Research Inc; 🇺🇸 Santa Monica, California, United States

St. Joseph'S Medical Associates; 🇺🇸 Stockton, California, United States

Florida Research Network, Llc; 🇺🇸 Gainesville, Florida, United States

Cedar Crosse Research Center; 🇺🇸 Chicago, Illinois, United States

Preferred Primary Care Physicians; 🇺🇸 Uniontown, Pennsylvania, United States

Med-Cure Primary Care Physicians; 🇺🇸 Rosenberg, Texas, United States

Clinical Therapeutics Corporation; 🇺🇸 Coral Gables, Florida, United States

Internal Medicine Of Greer; 🇺🇸 Greer, South Carolina, United States

Fpa Clinical Research; 🇺🇸 Kissimmee, Florida, United States

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

Middle Georgia Drug Study Center, Llc; 🇺🇸 Perry, Georgia, United States

Emerald Coast Research Group; 🇺🇸 Marianna, Florida, United States

Baptist Diabetes Associates; 🇺🇸 Miami, Florida, United States

Adviso Medical Research, Llc; 🇺🇸 Chicago, Illinois, United States

Deerbrook Medical Associates; 🇺🇸 Vernon Hills, Illinois, United States

Physicians Research Group; 🇺🇸 Indianapolis, Indiana, United States

Professional Network Research Of Kansas; 🇺🇸 Wichita, Kansas, United States

Midwest Regional Research, Inc.; 🇺🇸 Bellbrook, Ohio, United States

Non Invasive Cardiovascular Pa; 🇺🇸 Houston, Texas, United States

Safe Harbor Clinical Research; 🇺🇸 E. Providence, Rhode Island, United States

Frontier Clinical Research, Llc.; 🇺🇸 Memphis, Tennessee, United States

Endocrine Associates; 🇺🇸 Houston, Texas, United States

Advances In Health,Inc; 🇺🇸 Houston, Texas, United States

Juno Research, Llc; 🇺🇸 Houston, Texas, United States

Middle Tennessee Clinical Research; 🇺🇸 Fayetteville, Tennessee, United States

Tiena Health Research; 🇺🇸 Irving, Texas, United States

Diabetes Center Of The Southwest; 🇺🇸 Midland, Texas, United States

Pearland Primary Care Associates, Llp; 🇺🇸 Pearland, Texas, United States

Gsa Research; 🇺🇸 San Antonio, Texas, United States

Covenant Clinical Research, Pa; 🇺🇸 San Antonio, Texas, United States

Local Institution; 🇺🇦 Ternopil, Ukraine

Metrolina Medical Research; 🇺🇸 Charlotte, North Carolina, United States

Medical Arts Research Collaborative, Llc; 🇺🇸 Excelsior Springs, Missouri, United States

Nevada Alliance Against Diabetes; 🇺🇸 N. Las Vegas, Nevada, United States

Durham Internal Medicine Assoc.; 🇺🇸 Durham, North Carolina, United States

Down East Medical Associates; 🇺🇸 Morehead City, North Carolina, United States

Massillon Family Practice; 🇺🇸 Massillon, Ohio, United States

Your Diabetes Endocrine Nutrition Group; 🇺🇸 Mentor, Ohio, United States

Capital Medical Clinic, Llp; 🇺🇸 Austin, Texas, United States

Hill Country Medical Associates; 🇺🇸 New Braunfels, Texas, United States

S.A.M. Clinical Research Center; 🇺🇸 San Antonio, Texas, United States

Seven Corners Medical Research Center; 🇺🇸 Falls Church, Virginia, United States

Salem Va Medical Ctr Research & Devlopment; 🇺🇸 Salem, Virginia, United States

Physicians Clinic Of Spokane; 🇺🇸 Spokane, Washington, United States