Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Phase 3

Completed

• Conditions: Diabetes
• Interventions: Drug: Placebo; Drug: Saxagliptin; Drug: metformin

• Registration Number: NCT00316082
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

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 (rescue medication) added onto their blinded study medication

Study Timeline

• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-19
• Study First Posted: 2006-04-20
• Study Start: 2006-06
• Primary Completion: 2007-11
• Study Completion: 2008-11
• 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: 365

Inclusion Criteria

• Type 2 diabetes
• Inadequate blood sugar control

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Exclusion Criteria

• Previous treatment for diabetes
• Current treatment with other medications to lower blood sugar
• Major heart, liver or kidney problems
• Women who are pregnant or breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (E)	Placebo	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QAM (C)	Saxagliptin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QPM (D)	Saxagliptin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg QAM (A)	metformin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QAM (C)	metformin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)	Saxagliptin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg QAM (A)	Saxagliptin	PLUS open-label metformin (as needed as rescue medication)
Placebo (E)	metformin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)	metformin	PLUS open-label metformin (as needed as rescue medication)
Saxagliptin 5 mg QPM (D)	metformin	PLUS open-label metformin (as needed as rescue medication)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1 (A1C) at Week 24	Baseline, Week 24	Mean change from baseline in A1C at Week 24, adjusted for baseline value.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving A1C < 7% at Week 24	Week 24	Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo 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	Baseline, Week 24	Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM	Baseline, Week 24	Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline, Week 24	Mean change from baseline in FPG at Week 24, adjusted for baseline value.

Trial Locations

Locations (51)

Southland Clinical Research Center, Inc.; 🇺🇸 Fountain Valley, California, United States

Winston Technology, Inc.; 🇺🇸 Haleyville, Alabama, United States

Clinical Reseacrh Advantage/ Brown Family Medicine; 🇺🇸 Mesa, Arizona, United States

Medical Group Of Encino; 🇺🇸 Encino, California, United States

Tomac, Inc.; 🇺🇸 Columbiana, Alabama, United States

Strategos Medical Group; 🇺🇸 Bakersfield, California, United States

Valley Research; 🇺🇸 Fresno, California, United States

Diabetes Medical Center Of California; 🇺🇸 Northridge, California, United States

In Private Prictice Clinic; 🇺🇸 Pico Rivera, California, United States

Hudson Valley Clinical Research Center; 🇺🇸 Kingston, New York, United States

Wells Institute For Health Awareness; 🇺🇸 Kettering, Ohio, United States

Alpha Therapy Research Center; 🇺🇸 Corpus Christi, Texas, United States

Taylor/Wade Medical; 🇺🇸 Bountiful, Utah, United States

Accelovance; 🇺🇸 Oklahoma City, Oklahoma, United States

Banksville Medical, Pc; 🇺🇸 Pittsburgh, Pennsylvania, United States

Texas Center For Drug Development, P.A.; 🇺🇸 Houston, Texas, United States

Abbott Clinical Research Group, Inc; 🇺🇸 San Antonio, Texas, United States

University Family Healthcare, Pa; 🇺🇸 Sarasota, Florida, United States

Fleetwood Clinical Research; 🇺🇸 Fleetwood, Pennsylvania, United States

Southwind Medical Specialist; 🇺🇸 Memphis, Tennessee, United States

Crescent Medical Research; 🇺🇸 Salisbury, North Carolina, United States

Middle Tyger Family Medicine; 🇺🇸 Duncan, South Carolina, United States

Community Health Care, Inc.; 🇺🇸 Barberton, Ohio, United States

Southeastern Research Assoc; 🇺🇸 Taylors, South Carolina, United States

Clinical Research Limited; 🇺🇸 Canton, Ohio, United States

Providence Clinical Research; 🇺🇸 Burbank, California, United States

Pinnacle Medical Research; 🇺🇸 Overland Park, Kansas, United States

Central Florida Clinical Trials, Inc.; 🇺🇸 Altamonte Springs, Florida, United States

Physicians Research Center; 🇺🇸 Toms River, New Jersey, United States

Premier Healthcare; 🇺🇸 St. Petersburg, Florida, United States

Kansas City University Of Medicine And Biosciences; 🇺🇸 Kansas City, Missouri, United States

San Jose Clinical Research, Inc.; 🇺🇸 San Jose, California, United States

Primary Care Physicians, Pc; 🇺🇸 Wentzville, Missouri, United States

Neem Research Group Of Charlotte; 🇺🇸 Charlotte, North Carolina, United States

Clinical Research Source, Inc; 🇺🇸 Perrysburg, Ohio, United States

Cumberland Valley Endocrinology Center, Llc; 🇺🇸 Carlisle, Pennsylvania, United States

Versoza & Ungab Internal Medicine Associates; 🇺🇸 Bartlett, Tennessee, United States

Integris Family Care South; 🇺🇸 Oklahoma City, Oklahoma, United States

Village Family Practice; 🇺🇸 Houston, Texas, United States

The Office Of Patricia Buchanan; 🇺🇸 Eugene, Oregon, United States

Precision Family Medicine; 🇺🇸 Carrollton, Texas, United States

Biomedical Research Associates, Llc; 🇺🇸 Shippensburg, Pennsylvania, United States

Local Institution; 🇨🇳 Tao-Yuan County, Taiwan

Optimum Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

Tidewater Integrated Medical Research; 🇺🇸 Virginia Beach, Virginia, United States

Spokane Internal Medicine; 🇺🇸 Spokane, Washington, United States

Collierville Medical Specialist; 🇺🇸 Collierville, Tennessee, United States

Med-South Research; 🇺🇸 Memphis, Tennessee, United States

Holston Medical Group; 🇺🇸 Kingsport, Tennessee, United States

Rx For Life, Inc; 🇺🇸 Cudahy, California, United States

Diabetes Center- East Carolina University; 🇺🇸 Greenville, North Carolina, United States