A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
- Winston Technology, Inc.
- Sunbelt Research Group, Llc
- Iicr, Inc.
- Clinical Research Advantage, Inc
- Nea Clinic
- Little Rock Family Practice Clinic
- Impact Clinical Trials
- Lovelace Scientific Resources, Inc.
- Medical Group Of Encino
- Marin Endocrine Care And Research, Inc.
- Del Rosario Medical Clinic, Inc.
- Loma Linda Va Healthcare Systems
- Peak Health Medical Group
- Richard Cherlin, Md
- Mission Internal Medical Group
- Desert Medical Advances
- Denver Internal Medicine Group
- Stamford Therapeutics Consortium
- Phoenix Internal Medicine Associates, Llc
- Central Florida Clinical Trials, Inc.
- Southern Family Healthcare, Pa
- Doctors Medical Center Of Walton County
- Horizon Institute For Clinical Research
- Jacksonville Center For Clinical Research
- Panhandle Family Care Associates
- Nextphase Clinical Trials, Inc
- Baptist Diabetes Associates
- Heart & Vascular Center Research, Inc.
- Alan B. Miller, Md
- Marietta Clinical Research, Inc.
- Endocrine Research Solutions, Inc.
- D. Thomas Rogers, Md, Facs
- Southeast Idaho Family Practice
- Cedar-Crosse Research Center
- Physicians Research Group
- Northwest Indiana Center For Clinical Research
- Lipid Research Clinic
- Professional Research Network Of Kansas
- Mouhaffel, Assad H.
- Promed Physicians Family Practice
- Olive Branch Family Medical Center
- Radiant Research Las Vegas
- Nevada Alliance Against Diabetes
- Office Of Ammar Bazerbashi, Md
- Urgentmed, P.C.
- Medical Research Associates Of Charlotte, Inc.
- Carolina Pharmaceutical Research
- Community Health Care
- Clinical Research Limited
- Rapid Medical Research, Inc.
- Providence Health Partners - Center For Clinical Research
- Holzer Clinic
- Wells Institute For Health Awareness
- David Witkin, Md
- Harleysville Medical Associates
- Family Medical Associates
- Banksville Medical Pc
- Three Rivers Medical Associates, Pa
- Radiant Research, Greer
- Upstate Pharmaceutical Research
- East Tennessee Medical Group
- Healthstar Physicians
- Hayes Endocrine And Diabetes Center
- Capital Medical Clinic, Llp
- Texas Diabetes And Endocrinology, P.A.
- Radiant Research-Austin
- Priscilla Hollander, Md, Phd
- The Medical Group Of Texas
- Mobley Research Center
- Family Physician, Pa
- Mapleridge Medical Center
- Diabetes Center Of The Southwest
- Pearland Primary Care Associates, Llp
- Med-Cure
- Radiant Research San Antonio
- S.A.M. Clinical Research Center
- Collom And Carney Clinic
- National Clinical Research, Inc.
- Tidewater Integrated Medical Research
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Saxagliptin plus open-label TZD (A)
Saxagliptin plus open-label TZD (B)
Placebo plus open-label TZD (C)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)