A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00295633
- Lead Sponsor
- AstraZeneca
- Brief 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
- 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 (defined as rescue medication) added onto their blinded study medication
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 565
- 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
- Symptomatic poorly controlled diabetes
- Recent cardiac or cerebrovascular event
- Serum creatinine > = 2.0 mg/dL
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saxagliptin plus open-label TZD (B) Saxagliptin Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Placebo plus open-label TZD (C) Placebo Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Placebo plus open-label TZD (C) rosiglitazone Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Placebo plus open-label TZD (C) metformin Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Saxagliptin plus open-label TZD (A) Saxagliptin Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Saxagliptin plus open-label TZD (A) pioglitazone Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Saxagliptin plus open-label TZD (A) metformin Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Saxagliptin plus open-label TZD (A) rosiglitazone Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Saxagliptin plus open-label TZD (B) pioglitazone Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Saxagliptin plus open-label TZD (B) metformin Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Saxagliptin plus open-label TZD (B) rosiglitazone Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) Placebo plus open-label TZD (C) pioglitazone Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (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 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.
Percentage of Participants Achieving A1c <7% at Week 24 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.
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 achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.
Trial Locations
- Locations (80)
Sunbelt Research Group, Llc
🇺🇸Mobile, Alabama, United States
Loma Linda Va Healthcare Systems
🇺🇸Loma Linda, California, United States
Mouhaffel, Assad H.
🇺🇸West Monroe, Louisiana, United States
Horizon Institute For Clinical Research
🇺🇸Hollywood, Florida, United States
Alan B. Miller, Md
🇺🇸Dunwoody, Georgia, United States
Marietta Clinical Research, Inc.
🇺🇸Marietta, Georgia, United States
Banksville Medical Pc
🇺🇸Pittsburgh, Pennsylvania, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Winston Technology, Inc.
🇺🇸Haleyville, Alabama, United States
Lovelace Scientific Resources, Inc.
🇺🇸Beverly Hills, California, United States
Del Rosario Medical Clinic, Inc.
🇺🇸Huntington Park, California, United States
Family Medical Associates
🇺🇸Levittown, Pennsylvania, United States
Priscilla Hollander, Md, Phd
🇺🇸Dallas, Texas, United States
Mapleridge Medical Center
🇺🇸Houston, Texas, United States
Family Physician, Pa
🇺🇸Houston, Texas, United States
Diabetes Center Of The Southwest
🇺🇸Midland, Texas, United States
Pearland Primary Care Associates, Llp
🇺🇸Pearland, Texas, United States
Professional Research Network Of Kansas
🇺🇸Wichita, Kansas, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
Little Rock Family Practice Clinic
🇺🇸Little Rock, Arkansas, United States
Radiant Research, Greer
🇺🇸Greer, South Carolina, United States
East Tennessee Medical Group
🇺🇸Alcoa, Tennessee, United States
Phoenix Internal Medicine Associates, Llc
🇺🇸Waterbury, Connecticut, United States
Office Of Ammar Bazerbashi, Md
🇺🇸Holmdel, New Jersey, United States
Local Institution
🇵🇷San Juan, Puerto Rico
Upstate Pharmaceutical Research
🇺🇸Simpsonville, South Carolina, United States
Radiant Research Las Vegas
🇺🇸Las Vegas, Nevada, United States
S.A.M. Clinical Research Center
🇺🇸San Antonio, Texas, United States
Hayes Endocrine And Diabetes Center
🇺🇸Nashville, Tennessee, United States
Impact Clinical Trials
🇺🇸Beverly Hills, California, United States
Denver Internal Medicine Group
🇺🇸Denver, Colorado, United States
Iicr, Inc.
🇺🇸Ozark, Alabama, United States
Desert Medical Advances
🇺🇸Palm Desert, California, United States
Clinical Research Advantage, Inc
🇺🇸Mesa, Arizona, United States
Nea Clinic
🇺🇸Jonesboro, Arkansas, United States
Southeast Idaho Family Practice
🇺🇸Idaho Falls, Idaho, United States
Medical Group Of Encino
🇺🇸Encino, California, United States
Richard Cherlin, Md
🇺🇸Los Gatos, California, United States
Marin Endocrine Care And Research, Inc.
🇺🇸Greenbrae, California, United States
Jacksonville Center For Clinical Research
🇺🇸Jacksonville, Florida, United States
Peak Health Medical Group
🇺🇸Los Angeles, California, United States
Southern Family Healthcare, Pa
🇺🇸Chipley, Florida, United States
Panhandle Family Care Associates
🇺🇸Marianna, Florida, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Physicians Research Group
🇺🇸Indianapolis, Indiana, United States
Three Rivers Medical Associates, Pa
🇺🇸Columbia, South Carolina, United States
Medical Research Associates Of Charlotte, Inc.
🇺🇸Charlotte, North Carolina, United States
D. Thomas Rogers, Md, Facs
🇺🇸Kahului, Hawaii, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Heart & Vascular Center Research, Inc.
🇺🇸Sarasota, Florida, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
Carolina Pharmaceutical Research
🇺🇸Statesville, North Carolina, United States
Clinical Research Limited
🇺🇸Canton, Ohio, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Nevada Alliance Against Diabetes
🇺🇸North Las Vegas, Nevada, United States
Lipid Research Clinic
🇺🇸Iowa City, Iowa, United States
Urgentmed, P.C.
🇺🇸South Bound Brook, New Jersey, United States
David Witkin, Md
🇺🇸Eugene, Oregon, United States
Wells Institute For Health Awareness
🇺🇸Kettering, Ohio, United States
National Clinical Research, Inc.
🇺🇸Richmond, Virginia, United States
Collom And Carney Clinic
🇺🇸Texarkana, Texas, United States
Mission Internal Medical Group
🇺🇸Mission Viejo, California, United States
Central Florida Clinical Trials, Inc.
🇺🇸Altamonte Springs, Florida, United States
Nextphase Clinical Trials, Inc
🇺🇸Miami, Florida, United States
Baptist Diabetes Associates
🇺🇸Miami, Florida, United States
Northwest Indiana Center For Clinical Research
🇺🇸Valparaiso, Indiana, United States
Promed Physicians Family Practice
🇺🇸Portage, Michigan, United States
Community Health Care
🇺🇸Canal Fulton, Ohio, United States
Providence Health Partners - Center For Clinical Research
🇺🇸Dayton, Ohio, United States
Holzer Clinic
🇺🇸Gallipolis, Ohio, United States
Harleysville Medical Associates
🇺🇸Harleysville, Pennsylvania, United States
The Medical Group Of Texas
🇺🇸Fort Worth, Texas, United States
Mobley Research Center
🇺🇸Houston, Texas, United States
Med-Cure
🇺🇸Rosenberg, Texas, United States
Radiant Research San Antonio
🇺🇸San Antonio, Texas, United States
Doctors Medical Center Of Walton County
🇺🇸Defuniak Springs, Florida, United States
Capital Medical Clinic, Llp
🇺🇸Austin, Texas, United States
Texas Diabetes And Endocrinology, P.A.
🇺🇸Austin, Texas, United States
Radiant Research-Austin
🇺🇸Austin, Texas, United States
Healthstar Physicians
🇺🇸Morristown, Tennessee, United States