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

Diabetes Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316082
• Other study ID #: CV181-038
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2006
• Last updated: April 8, 2015
• Start date: June 2006
• Est. completion date: November 2008

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: November 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Inadequate blood sugar control

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
• Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
• Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
• Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
• Placebo
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
• metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Locations

Country	Name	City	State
India	Local Institution	Attavar	Mangalore
India	Local Institution	Bangalore
India	Local Institution	Kochi	Kerala
India	Local Institution	Manipal	Karnataka
India	Local Institution	Mumbai
India	Local Institution	Mumbai
India	Local Institution	Nagpur
India	Local Institution	Sarita Vihar	New Delhi
Russian Federation	Local Institution	Moscov
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Nizhniy Novgorod
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	Smolensk
Russian Federation	Local Institution	St.Petersburg
Russian Federation	Local Institution	Volgograd
Taiwan	Local Institution	Changhua
Taiwan	Local Institution	Kaohsiung County
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taichung City
Taiwan	Local Institution	Taipei City
Taiwan	Local Institution	Tao-Yuan County
United States	Central Florida Clinical Trials, Inc.	Altamonte Springs	Florida
United States	Strategos Medical Group	Bakersfield	California
United States	Community Health Care, Inc.	Barberton	Ohio
United States	Versoza & Ungab Internal Medicine Associates	Bartlett	Tennessee
United States	Taylor/Wade Medical	Bountiful	Utah
United States	Providence Clinical Research	Burbank	California
United States	Clinical Research Limited	Canton	Ohio
United States	Cumberland Valley Endocrinology Center, Llc	Carlisle	Pennsylvania
United States	Precision Family Medicine	Carrollton	Texas
United States	Neem Research Group Of Charlotte	Charlotte	North Carolina
United States	Collierville Medical Specialist	Collierville	Tennessee
United States	Tomac, Inc.	Columbiana	Alabama
United States	Alpha Therapy Research Center	Corpus Christi	Texas
United States	Rx For Life, Inc	Cudahy	California
United States	Middle Tyger Family Medicine	Duncan	South Carolina
United States	Medical Group Of Encino	Encino	California
United States	The Office Of Patricia Buchanan	Eugene	Oregon
United States	Fleetwood Clinical Research	Fleetwood	Pennsylvania
United States	Southland Clinical Research Center, Inc.	Fountain Valley	California
United States	Valley Research	Fresno	California
United States	Diabetes Center- East Carolina University	Greenville	North Carolina
United States	Winston Technology, Inc.	Haleyville	Alabama
United States	Texas Center For Drug Development, P.A.	Houston	Texas
United States	Village Family Practice	Houston	Texas
United States	Kansas City University Of Medicine And Biosciences	Kansas City	Missouri
United States	Wells Institute For Health Awareness	Kettering	Ohio
United States	Holston Medical Group	Kingsport	Tennessee
United States	Hudson Valley Clinical Research Center	Kingston	New York
United States	Accelovance	Melbourne	Florida
United States	Med-South Research	Memphis	Tennessee
United States	Southwind Medical Specialist	Memphis	Tennessee
United States	Clinical Reseacrh Advantage/ Brown Family Medicine	Mesa	Arizona
United States	Diabetes Medical Center Of California	Northridge	California
United States	Accelovance	Oklahoma City	Oklahoma
United States	Integris Family Care South	Oklahoma City	Oklahoma
United States	Pinnacle Medical Research	Overland Park	Kansas
United States	Clinical Research Source, Inc	Perrysburg	Ohio
United States	In Private Prictice Clinic	Pico Rivera	California
United States	Banksville Medical, Pc	Pittsburgh	Pennsylvania
United States	Crescent Medical Research	Salisbury	North Carolina
United States	Optimum Clinical Research	Salt Lake City	Utah
United States	Abbott Clinical Research Group, Inc	San Antonio	Texas
United States	San Jose Clinical Research, Inc.	San Jose	California
United States	University Family Healthcare, Pa	Sarasota	Florida
United States	Biomedical Research Associates, Llc	Shippensburg	Pennsylvania
United States	Spokane Internal Medicine	Spokane	Washington
United States	Premier Healthcare	St. Petersburg	Florida
United States	Southeastern Research Assoc	Taylors	South Carolina
United States	Physicians Research Center	Toms River	New Jersey
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Primary Care Physicians, Pc	Wentzville	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  India,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1 (A1C) at Week 24	Mean change from baseline in A1C at Week 24, adjusted for baseline value.	Baseline, Week 24	No
Secondary	Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM	Mean change from baseline in A1C at Week 24, adjusted for baseline value.	Baseline, Week 24	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Mean change from baseline in FPG at Week 24, adjusted for baseline value.	Baseline, Week 24	No
Secondary	Percentage of Participants Achieving A1C < 7% at 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.	Week 24	No
Secondary	Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24	Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.	Baseline, Week 24	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm