Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.

Key facts

Study ID

NCT01646320

Run by

AstraZeneca

People needed

320

Starts

2012-09-01

Expected to finish

2015-02-01

Last updated by the study team

2016-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Written Informed Consent
• Subjects must be willing and able to give signed and dated written informed consent.
• Target Population
• For inclusion into Stratum A:
• i) Subjects with T2DM with inadequate glycemic control, defined as central laboratory HbA1c ≥ 8.0 and ≤ 11.5% obtained at the screening visit (ie Week -18 visit), on stable metformin therapy alone for at least 8 weeks prior to screening visit at a dose ≥ 1500 mg per day
• For inclusion into Stratum B:
• ii) Subjects with T2DM with inadequate glycemic control, and HbA1c ≥ 7.5 and ≤ 10.5% obtained at the screening visit and on stable metformin therapy at a dose ≥ 1500 mg per day AND a DPP4 inhibitor at the maximum approved dose for at least 8 weeks prior to screening visit.
• b) C-peptide ≥ 1.0 ng/mL (0.34 nmol/L) at screening visit. c) BMI ≤ 45.0 kg/m2 at the screening visit.
• Age and Reproductive Status
• Men and women, aged ≥ 18 years old at time of screening visit.
• Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
• WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product.
• Women must not be breastfeeding
• Sexually active fertile men must use highly effective birth control if their partners are WOCBP.

You may not qualify if…

• Target Disease Exceptions
• History of diabetes insipidus
• Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the three months prior to screening, or other signs and symptoms.
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
• Medical History and Concurrent Diseases
• History of bariatric surgery or lap-band procedure within 12 months prior to screening.
• Any unstable endocrine, psychiatric or rheumatic disorders as judged by the Investigator.
• Subject who, in the judgment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data and concomitant use of loop diuretics in countries where this is not recognized in the Dapagliflozin label.
• Subject is currently abusing alcohol or other drugs or has done so within the last 6 months.
• Acute Vascular Event:
• Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg.
• Cardiovascular Disease within 3 months of the screening visit [ie myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, stroke or transient ischemic attack (TIA)].
• Congestive heart failure as New York Association (NYHA) class IV, unstable or acute congestive heart failure.
• Renal Diseases:
• Moderate or severe impairment of renal function [defined as eGFR < 60 mL/min/1.73m2 (estimated by MDRD) or serum creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females.]
• Conditions of congenital renal glucosuria
• Hepatic Diseases:
• Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency, including subjects with ALT and/or AST > 3x ULN and or Total Bilirubin > 2.5 x ULN.
• Hematological and Oncological Disease/Conditions:
• History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis.
• Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma)
• Known immunocompromised status, including but not limited to, individuals who have undergone organ transplantation or who are positive for the human immunodeficiency virus.
• Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 6 months prior to the screening visit.
• Prohibited treatment and therapies:
• Administration of any antihyperglycemic therapy, other than metformin and DPP4's, for more than 14 days (consecutive or not) during the 12 weeks prior to screening, as well as previous exposure to DPP4 or SGLT-2 inhibitor in any DPP4 or SGLT-2 inhibitor trial is an exclusion criterion.

Where it is running

• Clinical Research Advantage Inc/Desert Clinical Research Llc — Mesa, Arizona, United States
• Clinical Research Advantage, Inc. — Phoenix, Arizona, United States
• Elite Clinical Studies, Llc — Phoenix, Arizona, United States
• Arkansas Clinical Research — Little Rock, Arkansas, United States
• Torrance Clinical Research Institute Inc. — Lomita, California, United States
• Randall G. Shue, Do, Inc. — Los Angeles, California, United States
• National Research Institute — Los Angeles, California, United States
• Diabetes Medical Center Of California — Northridge, California, United States
• Cassidy Medical Group/Clinical Research Advantage — Vista, California, United States
• Palm Springs Research Institute — Hialeah, Florida, United States
• Fpa Clinical Research — Kissimmee, Florida, United States
• International Research Associates, Llc — Miami, Florida, United States
• Omega Research Consultants, Llc — Orlando, Florida, United States
• Compass Research East, Llc — Oviedo, Florida, United States
• Palm Harbor Medical Associates — Palm Harbor, Florida, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• Clinical Research Advantage — Evansville, Indiana, United States
• Associated Internal Medicine Specialists — Battle Creek, Michigan, United States
• Jackson Clinic — Rolling Fork, Mississippi, United States
• Premier Research — Trenton, New Jersey, United States
• Metrolina Internal Medicine — Charlotte, North Carolina, United States
• Sterling Research Grp, Ltd. — Cincinnati, Ohio, United States
• Endocrine Associates — Houston, Texas, United States
• Sam Clinical Research Center — San Antonio, Texas, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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