A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295633
• Other study ID #: CV181-013
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2006
• Last updated: March 18, 2015
• Start date: March 2006
• Est. completion date: October 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 clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone

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 (defined as rescue medication) added onto their blinded study medication

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: October 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.

• Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5%

• Body mass index < = 45kg/m2

• Fasting C-peptide > = 1 ng/mL

Exclusion Criteria:

• Symptomatic poorly controlled diabetes

• Recent cardiac or cerebrovascular event

• Serum creatinine > = 2.0 mg/dL

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 Mellitus, Type 2

Intervention

Drug:
• Saxagliptin
Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)
• Saxagliptin
Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)
• Placebo
Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)
• pioglitazone
Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)
• rosiglitazone
Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)
• metformin
Tablets, Oral, 500-2500 mg, as needed (12 months LT)

Locations

Country	Name	City	State
Argentina	Local Institution	Belgrano	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Chacabuco	Buenos Aires
Argentina	Local Institution	Ciudad Auton.	Buenos Aires
Argentina	Local Institution	Ciudad De Mendoza	Mendoza
Argentina	Local Institution	La Plata	Buenos Aires
Argentina	Local Institution	Lanus Este	Tucuman
Argentina	Local Institution	Moron	Buenos Aires
Argentina	Local Institution	Rosario	Santa Fe
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	Sarnia	Ontario
Canada	Local Institution	Saskatoon	Saskatchewan
Canada	Local Institution	St Catharines	Ontario
Canada	Local Institution	St-Leonard	Quebec
Canada	Local Institution	St. Johns	Newfoundland and Labrador
Canada	Local Institution	Ste-Foy	Quebec
India	Local Institution	Bangalore
India	Local Institution	Bangalore
India	Local Institution	Chennai
India	Local Institution	Chennai
India	Local Institution	Chennai
India	Local Institution	Chennai
India	Local Institution	Hariyana
India	Local Institution	Hyderabad
India	Local Institution	Indore
India	Local Institution	Maharashtra
India	Local Institution	Mangalore
India	Local Institution	Mumbai
India	Local Institution	Mumbai
India	Local Institution	Pune
India	Local Institution	Vellore
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Angeles Del Pedregal	Distrito Federal
Mexico	Local Institution	Chichuahua	Chihuahua
Mexico	Local Institution	Michoacan	Morelos
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Zapopan	Jalisco
Peru	Local Institution	Cercado De Lima	Lima
Peru	Local Institution	La Victoria	Lima
Peru	Local Institution	Miraflores	Lima
Peru	Local Institution	San Isidro	Lima
Peru	Local Institution	San Martin De Porres	Lima
Peru	Local Institution	Santiago De Surco	Lima
Philippines	Local Institution	Cebu City
Philippines	Local Institution	Cebu City
Philippines	Local Institution	Iloilo City
Philippines	Local Institution	Las Pinas
Philippines	Local Institution	Pasig City
Puerto Rico	Local Institution	Carolina
Puerto Rico	Local Institution	Ponce
Puerto Rico	Local Institution	Ponce
Puerto Rico	Local Institution	Rio Piedras
Puerto Rico	Local Institution	San Juan
United States	East Tennessee Medical Group	Alcoa	Tennessee
United States	Central Florida Clinical Trials, Inc.	Altamonte Springs	Florida
United States	Capital Medical Clinic, Llp	Austin	Texas
United States	Radiant Research-Austin	Austin	Texas
United States	Texas Diabetes And Endocrinology, P.A.	Austin	Texas
United States	Impact Clinical Trials	Beverly Hills	California
United States	Lovelace Scientific Resources, Inc.	Beverly Hills	California
United States	Community Health Care	Canal Fulton	Ohio
United States	Clinical Research Limited	Canton	Ohio
United States	Medical Research Associates Of Charlotte, Inc.	Charlotte	North Carolina
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Southern Family Healthcare, Pa	Chipley	Florida
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Three Rivers Medical Associates, Pa	Columbia	South Carolina
United States	Priscilla Hollander, Md, Phd	Dallas	Texas
United States	Providence Health Partners - Center For Clinical Research	Dayton	Ohio
United States	Doctors Medical Center Of Walton County	Defuniak Springs	Florida
United States	Denver Internal Medicine Group	Denver	Colorado
United States	Alan B. Miller, Md	Dunwoody	Georgia
United States	Medical Group Of Encino	Encino	California
United States	David Witkin, Md	Eugene	Oregon
United States	The Medical Group Of Texas	Fort Worth	Texas
United States	Holzer Clinic	Gallipolis	Ohio
United States	Marin Endocrine Care And Research, Inc.	Greenbrae	California
United States	Radiant Research, Greer	Greer	South Carolina
United States	Winston Technology, Inc.	Haleyville	Alabama
United States	Harleysville Medical Associates	Harleysville	Pennsylvania
United States	Horizon Institute For Clinical Research	Hollywood	Florida
United States	Office Of Ammar Bazerbashi, Md	Holmdel	New Jersey
United States	Family Physician, Pa	Houston	Texas
United States	Mapleridge Medical Center	Houston	Texas
United States	Mobley Research Center	Houston	Texas
United States	Del Rosario Medical Clinic, Inc.	Huntington Park	California
United States	Southeast Idaho Family Practice	Idaho Falls	Idaho
United States	Physicians Research Group	Indianapolis	Indiana
United States	Lipid Research Clinic	Iowa City	Iowa
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	Nea Clinic	Jonesboro	Arkansas
United States	D. Thomas Rogers, Md, Facs	Kahului	Hawaii
United States	Wells Institute For Health Awareness	Kettering	Ohio
United States	Radiant Research Las Vegas	Las Vegas	Nevada
United States	Family Medical Associates	Levittown	Pennsylvania
United States	Little Rock Family Practice Clinic	Little Rock	Arkansas
United States	Loma Linda Va Healthcare Systems	Loma Linda	California
United States	Peak Health Medical Group	Los Angeles	California
United States	Richard Cherlin, Md	Los Gatos	California
United States	Panhandle Family Care Associates	Marianna	Florida
United States	Marietta Clinical Research, Inc.	Marietta	Georgia
United States	Clinical Research Advantage, Inc	Mesa	Arizona
United States	Baptist Diabetes Associates	Miami	Florida
United States	Nextphase Clinical Trials, Inc	Miami	Florida
United States	Diabetes Center Of The Southwest	Midland	Texas
United States	Mission Internal Medical Group	Mission Viejo	California
United States	Sunbelt Research Group, Llc	Mobile	Alabama
United States	Healthstar Physicians	Morristown	Tennessee
United States	Hayes Endocrine And Diabetes Center	Nashville	Tennessee
United States	Nevada Alliance Against Diabetes	North Las Vegas	Nevada
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	Iicr, Inc.	Ozark	Alabama
United States	Desert Medical Advances	Palm Desert	California
United States	Pearland Primary Care Associates, Llp	Pearland	Texas
United States	Banksville Medical Pc	Pittsburgh	Pennsylvania
United States	Promed Physicians Family Practice	Portage	Michigan
United States	National Clinical Research, Inc.	Richmond	Virginia
United States	Med-Cure	Rosenberg	Texas
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Radiant Research San Antonio	San Antonio	Texas
United States	S.A.M. Clinical Research Center	San Antonio	Texas
United States	Heart & Vascular Center Research, Inc.	Sarasota	Florida
United States	Upstate Pharmaceutical Research	Simpsonville	South Carolina
United States	Urgentmed, P.C.	South Bound Brook	New Jersey
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Carolina Pharmaceutical Research	Statesville	North Carolina
United States	Collom And Carney Clinic	Texarkana	Texas
United States	Northwest Indiana Center For Clinical Research	Valparaiso	Indiana
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Phoenix Internal Medicine Associates, Llc	Waterbury	Connecticut
United States	Mouhaffel, Assad H.	West Monroe	Louisiana
United States	Professional Research Network Of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  India,  Mexico,  Peru,  Philippines,  Puerto Rico, 

References & Publications (1)

Hollander P, Li J, Allen E, Chen R; CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab. 2009 Dec;94(12):4810-9. doi: 10.1210/jc.2009-0550. Epub 2009 Oct 28. — 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 Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD 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 achieved at each dose of saxagliptin plus TZD versus placebo plus TZD 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