A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

Diabetes Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313313
• Other study ID #: CV181-040
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2006
• Last updated: April 14, 2015
• Start date: April 2006
• Est. completion date: September 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 adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

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 (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 768
• Est. completion date: September 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

Inclusion Criteria:

• Type 2 Diabetes.

• Treated with a sulfonylurea for at least 2 months.

• Inadequate blood sugar control.

• Are not on any other medications to lower blood sugar.

• No major heart, liver or kidney problems.

• Women not pregnant or breast feeding.

Study Design

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Saxagliptin
Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])
• Saxagliptin
Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
• Glyburide
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)
• Placebo
Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)
• Glyburide
Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)
• Metformin
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Mar Del Plata	Buenos Aires
Brazil	Local Institution	B. Rodolfo Teofilo	Ceara
Brazil	Local Institution	Belem	Para
Brazil	Local Institution	Belo Horizonte	Minas Gerais
Brazil	Local Institution	Campinas	Sao Paulo
Brazil	Local Institution	Fortaleza	Ceara
Brazil	Local Institution	Marília	Sao Paulo
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Sao Paulo - Sp	Sao Paulo
Brazil	Local Institution	Vila Mariana	Sao Paulo
Hong Kong	Local Institution	Hong Kong
Hong Kong	Local Institution	Kowloon
Israel	Local Institution	Givatayim
Israel	Local Institution	Haifa
Israel	Local Institution	Holon
Israel	Local Institution	Jerusalem
Israel	Local Institution	Rishon Le-Zion
Israel	Local Institution	Tel Aviv
Israel	Local Institution	Zefat
Israel	Local Institution	Zerifin
Korea, Republic of	Local Institution	Kyunggi-Do
Korea, Republic of	Local Institution	Kyunggi-Do
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Suwon
Mexico	Local Institution	Cuernavaca	Morelos
Mexico	Local Institution	Df	Distrito Federal
Mexico	Local Institution	Durango
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Merida	Yucatan
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Tijuana, B.C.	Baja California
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Peru	Local Institution	San Isidro	Lima
Philippines	Local Institution	Cebu
Philippines	Local Institution	Manila
Philippines	Local Institution	Quezon
Puerto Rico	Local Institution	Carolina
Puerto Rico	Local Institution	Guaynabo
Puerto Rico	Local Institution	Ponce
Puerto Rico	Local Institution	Ponce
Singapore	Local Institution	Singapore
South Africa	Local Institution	Cape Town
South Africa	Local Institution	Johannesburg
South Africa	Local Institution	Kimberley	Northern Cape
South Africa	Local Institution	Tygerberg	Western Cape
South Africa	Local Institution	Umhlanga Rocks	Kwa Zulu Natal
Taiwan	Local Institution	Changhua
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taipei
United States	Daystar Clinical Research, Inc.	Akron	Ohio
United States	Stewart Medical Group	Alhambra	California
United States	Central Florida Clinical Trials	Altamonte Springs	Florida
United States	Capital Medical Clinic, Llp	Austin	Texas
United States	Community Health Care	Canal Fulton	Ohio
United States	Med Res Assoc Charlotte	Charlotte	North Carolina
United States	Metrolina Internal Medicine	Charlotte	North Carolina
United States	Cedar-Crosse Research Ctr	Chicago	Illinois
United States	Family Care Assoc & Emerald Care Res Grp	Chipley	Florida
United States	Columbia Medical Practice	Columbia	Maryland
United States	Clinical Therapeutics Corporation	Coral Gables	Florida
United States	Atlanta Pharmaceutical Research Center, Inc	Dunwoody	Georgia
United States	Cny Family Care	East Syracuse	New York
United States	Coordinators Plus, Llc	Eugene	Oregon
United States	Southland Clinical Research Center, Inc.	Fountain Valley	California
United States	Triphase Research, Ltd.	Franklin	Ohio
United States	Valley Research	Fresno	California
United States	New West Physicians	Golden	Colorado
United States	Regional Physicians Research	High Point	North Carolina
United States	Texas Center For Drug Development, P.A.	Houston	Texas
United States	Reserach Solutions, Llc	Jonesboro	Arkansas
United States	Va Medical Center	Kansas City	Missouri
United States	Breath Of Life Research Institute	Katy	Texas
United States	Fpa Clinical Research	Kissimmee	Florida
United States	Randall Shue, D.O.	Los Angeles	California
United States	Emerald Coast Research Group	Marianna	Florida
United States	Albert J Weisbrot,Md&Assoc Inc	Mason	Ohio
United States	University Of Miami Diabetes Research Inst.	Miami	Florida
United States	Advanced Healthcare S.C.	Milwaukee	Wisconsin
United States	Diabetes & Endocrinology Consultants, Pc	Morehead City	North Carolina
United States	Family Medical Center Of Hart Co.	Munfordville	Kentucky
United States	Christiana Care Research Institute	Newark	Delaware
United States	Pearl Clinical Research	Norristown	Pennsylvania
United States	Nevada Alliance Against Diabetes	North Las Vegas	Nevada
United States	Oklahoma Cardiovascular And Hypertension Center	Oklahoma City	Oklahoma
United States	Banksville Medical Pc	Pittsburgh	Pennsylvania
United States	Oregon Clinical Research	Portland	Oregon
United States	Clinical Trials Research	Roseville	California
United States	Diabetes & Glandular Disease Research Assoc, Pa	San Antonio	Texas
United States	S.A.M. Clinical Research Center	San Antonio	Texas
United States	Guthrie Clinic, Ltd	Sayre	Pennsylvania
United States	Searcy Medical Center	Searcy	Arkansas
United States	Upstate Pharmaceutical Research	Simsonville	South Carolina
United States	Mountain Top Clinical Research Center	Sparta	North Carolina
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Office Of Dr. Gray	Spokane	Washington
United States	St. Louis Center For Clinical Research	St. Louis	Missouri
United States	Southeastern Research Assoc	Taylors	South Carolina
United States	Physicians Research Center	Toms River	New Jersey
United States	Utica Park Clinic	Tulsa	Oklahoma
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Phoenix Internal Medicine Associates, Llc	Waterbury	Connecticut
United States	Dr Bahagwan Dass Md	Youngstown	Ohio
United States	Integris Family Care Yukon	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Hong Kong,  Israel,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Puerto Rico,  Singapore,  South Africa,  Taiwan, 

References & Publications (1)

Chacra AR, Tan GH, Apanovitch A, Ravichandran S, List J, Chen R; CV181-040 Investigators. Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial. Int J Clin Pract. 2009 Sep;63(9):1395-406. doi: 10.1111/j.1742-1241.2009.02143.x. Epub 2009 Jul 15. Erratum in: Int J Clin Pract. 2010 Jan;64(2):277. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (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 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 plus glyburide versus placebo plus upward titrated glyburide 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 values.	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