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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Dapagliflozin (Drug); Placebo matching with Dapagliflozin (Drug); Saxagliptin (Drug); Metformin immediate release (IR) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxagliptin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Saxagliptin

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Mean change from baseline in Glycosylated hemoglobin (HbA1c)

Mean change from baseline in Glycosylated hemoglobin (HbA1c)

Secondary outcome:

Mean change from baseline in fasting plasma glucose (FPG)

Mean change from baseline in 2-hour post-prandial glucose during a liquid meal tolerance test (2-h MTT)

Mean change from baseline in total body weight

Percent of subjects achieving a therapeutic glycemic response, defined as a HbA1c < 7.0%

Detailed description: Prior to randomization, all eligible subjects will receive open-label treatment with Saxagliptin 5mg and Metformin IR during the 16-week open-label treatment period.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females, ≥ 18 years old, with type 2 diabetes with inadequate glycemic

control HbA1c ≥ 7. 5% - ≤ 11. 5%

- Stable dose of Metformin for at least 8 weeks

- C-peptide ≥ 1. 0 ng/mL

- Body Mass Index ≤ 45. 0 kg/m2

Exclusion Criteria:

- Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1. 73m2 or serum creatinine

(Scr) ≥ 1. 5 mg/dL in males or ≥ 1. 4 mg/dL in females

- Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3. 0 times

the upper limit of normal (ULN)

- Serum total bilirubin > 2. 5 x ULN

- Systolic blood pressure (SBP) ≥ 160 mmHg and/or Diastolic blood pressure (DBP) ≥

100mmHg

- Cardiovascular disease within 3 months of the screening visit

- Currently unstable or serious cardiovascular, renal, hepatic, hematological,

oncological, endocrine, psychiatric, or rheumatic diseases

Locations and Contacts

Local Institution, Broumov 550 01, Czech Republic

Local Institution, Pardubice 530 02, Czech Republic

Local Institution, Praha 10 100 00, Czech Republic

Local Institution, Praha 4 149 00, Czech Republic

Local Institution, Pribram V 261 95, Czech Republic

Local Institution, Aguascalientes 20127, Mexico

Local Institution, Bialystok 15-435, Poland

Local Institution, Krakow 30-015, Poland

Local Institution, Ruda Slaska 41-709, Poland

Local Institution, Warszawa 00-465, Poland

Local Institution, Warszawa 01-868, Poland

Local Institution, Warszawa 03-003, Poland

Local Institution, Zory 44-240, Poland

Clinical Research Puerto Rico, San Juan 00909, Puerto Rico

Local Institution, Bucharest 010825, Romania

Local Institution, Bucharest 070208, Romania

Local Institution, Constanta 900591, Romania

Local Institution, Craiova 200349, Romania

Local Institution, Galati 800098, Romania

Local Institution, Ploiesti 100097, Romania

Local Institution, Kursk 305035, Russian Federation

Local Institution, Moscow 119034, Russian Federation

Local Institution, Saint-petersburg 194044, Russian Federation

Local Institution, St. Petersburg 194044, Russian Federation

Local Institution, St. Petersburg 194156, Russian Federation

Local Institution, St. Petersburg 195257, Russian Federation

Local Institution, St. Petersburg 197136, Russian Federation

Local Institution, St.petersburg 195112, Russian Federation

Local Institution, St.petersburg 197022, Russian Federation

Local Institution, Yaroslaval 150062, Russian Federation

Local Institution, Bedfordshire SG19 3JR, United Kingdom

Local Institution, London W6 7HY, United Kingdom

University Of Alabama At Birmingham, Birmingham, Alabama 35294, United States

Clinical Research Advantage Inc/Desert Clinical Research Llc, Mesa, Arizona 85213, United States

Clinical Research Advantage, Inc., Phoenix, Arizona 85018, United States

Elite Clinical Studies, Llc, Phoenix, Arizona 85018, United States

Arkansas Clinical Research, Little Rock, Arkansas 72205, United States

Torrance Clinical Research Institute Inc., Lomita, California 90717, United States

National Research Institute, Los Angeles, California 90057, United States

Randall G. Shue, Do, Inc., Los Angeles, California 90023, United States

Diabetes Medical Center Of California, Northridge, California 91325, United States

Cassidy Medical Group/Clinical Research Advantage, Vista, California 92083, United States

Palm Springs Research Institute, Hialeah, Florida 33012, United States

Fpa Clinical Research, Kissimmee, Florida 34741, United States

International Research Associates, Llc, Miami, Florida 33183, United States

Omega Research Consultants, Llc, Orlando, Florida 32804, United States

Compass Research East, Llc, Oviedo, Florida 32765, United States

Palm Harbor Medical Associates, Palm Harbor, Florida 34684, United States

Local Institution, Portsmouth, Hants PO3 6LY, United Kingdom

Cedar Crosse Research Center, Chicago, Illinois 60607, United States

Clinical Research Advantage, Evansville, Indiana 47714, United States

Local Institution, Newport, Isle of Wight PO30 5TG, United Kingdom

Local Institution, Guadalajara, Jalisco 44670, Mexico

Local Institution, Zapopan, Jalisco 45116, Mexico

Local Institution, Zapopan, Jalisco 45200, Mexico

Local Institution, Liverpool, Merseyside L7 8XP, United Kingdom

Associated Internal Medicine Specialists, Battle Creek, Michigan 49015, United States

Jackson Clinic, Rolling Fork, Mississippi 39159, United States

Premier Research, Trenton, New Jersey 08611, United States

Metrolina Internal Medicine, Charlotte, North Carolina 28204, United States

Local Institution, Monterrey, Nuevo Leon 64060, Mexico

Local Institution, Monterrey, Nuevo Leon 64460, Mexico

Sterling Research Grp, Ltd., Cincinnati, Ohio 45246, United States

Endocrine Associates, Houston, Texas 77004, United States

Sam Clinical Research Center, San Antonio, Texas 78229, United States

Tidewater Integrated Medical Research, Virginia Beach, Virginia 23454, United States

Local Institution, Chippenham, Wiltshire SN15 1HP, United Kingdom

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: September 2012
Last updated: August 19, 2015

Page last updated: August 23, 2015

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