Safety and Efficacy of Saxagliptin 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-477118 (Saxagliptin) 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

NCT01619059

Run by

AstraZeneca

People needed

315

Starts

2012-06-01

Expected to finish

2015-01-01

Last updated by the study team

2016-04-22

Who can join

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

You may qualify if…

• Signed Written Informed Consent
• a) Subjects must be willing and able to give signed and dated written informed consent.
• Target Population
• 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)
• Stable metformin therapy for at least 8 weeks prior to screening visit at a dose ≥ 1500 mg per day.
• C-peptide ≥ 1.0 ng/mL (0.34 nmol/L) at screening visit.
• 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. See Section 3.3.3 for the definition of WOCBP.
• WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
• Women must not be breastfeeding
• Sexually active fertile men must use 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 recommended as per 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.
• Note: Subjects with SBP ≥ 160mmHg and < 180mmHg or a DBP ≥ 100 mmHg and < 110mmHg will be able to enter the lead-in period, provided their hypertension treatment is adjusted as deemed appropriate by the investigator. These subjects cannot be randomized if their blood pressure remains with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg measured at Day 1.
• 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 (see Appendix 1), unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially those who are on diuretic therapy, should have careful monitoring of their volumes status throughout the study.
• Renal Diseases:
• Moderate or severe impairment of renal function [defined as eGFR < 60 mL/min/1.73 m2 (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

Where it is running

• Terence T. Hart, Md — Muscle Shoals, Alabama, United States
• Mesa Family Medical Center — Mesa, Arizona, United States
• Clinical Research Advantage Inc/Desert Clinical Research Llc — Mesa, Arizona, United States
• Clinical Research Advantage, Inc — Phoenix, Arizona, United States
• Clinical Research Advantage, Inc./ Stonecreek Medical Associates, Pc — Phoenix, Arizona, United States
• Beach Physicians Clinical Research Corp. — Huntington Beach, California, United States
• Torrance Clinical Research — Lomita, California, United States
• Randall G. Shue, Do, Inc. — Los Angeles, California, United States
• National Research Institute — Los Angeles, California, United States
• Cassidy Medical Group/Clinical Research Advantage — Vista, California, United States
• Infosphere Clinical Research, Inc. — West Hills, California, United States
• New West Physicians, Pc — Golden, Colorado, United States
• Southeast Clinical Research, Llc — Chiefland, Florida, United States
• Clinical Therapeutics Corporation — Coral Gables, Florida, United States
• Medical Research Unlimited, Llc — Hialeah, Florida, United States
• University Of Florida Endocrinology & Diabetes — Jacksonville, Florida, United States
• Care Partners Clinical Research, Llc — Jacksonville, Florida, United States
• Clinical Research Of Miami, Inc. — Miami, Florida, United States
• Clinical Research Advantage, Inc. — Evansville, Indiana, United States
• Clinical Research Advantage — Evansville, Indiana, United States
• Mercy Health Research — St Louis, Missouri, United States
• Clinical Research Advantage, Inc. — Las Vegas, Nevada, United States
• Joslin Diabetes Center Affiliate Of Snhmc — Nashua, New Hampshire, United States
• N. Shore Diabetes & Endoc Assoc — New Hyde Park, New York, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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