Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

NCT00736879 | Completed Phase 3 Results

• 1 other identifier: MB102-032
• Study Type: interventional
• Target: 497
• Locations: 7 countries
• Sites: 62

Brief Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants

  Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.

  Baseline (Day 1), Week 24

Secondary Outcomes (11)

• Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants

  Baseline (Day 1), Week 24

• Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants

  Baseline (Day 1), Week 24

• Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants

  Baseline (Day 1), Week 24

• Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants

  Baseline (Day 1), Week 24

• Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants

  Baseline (Day 1), Week 24

Study Arms (4)

Dapagliflozin 1 mg

EXPERIMENTAL

Dapagliflozin: 1 mg

Drug: Dapagliflozin

Dapagliflozin 2.5 mg

EXPERIMENTAL

Dapagliflozin: 2.5 mg

Drug: Dapagliflozin

Dapagliflozin 5 mg

EXPERIMENTAL

Dapagliflozin: 5 mg

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo: 0 mg

Drug: Placebo

Interventions

Dapagliflozin DRUG

Tablets, Oral, Once Daily, Up to 24 weeks

Also known as: BMS-512148, Farxiga™

Dapagliflozin 1 mg; Dapagliflozin 2.5 mg; Dapagliflozin 5 mg

Placebo DRUG

Tablets, Oral, Once Daily, Up to 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
• Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
• C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
• Body Mass Index ≤ 45 kg/m²
• Must be able to perform self monitoring of blood glucose

You may not qualify if:

• aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3\* upper limit of normal (ULN)
• Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
• Creatinine kinase \>3\* ULN
• Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (62)

Dedicated Clinical Research

Litchfield Park, Arizona, 85340, United States

Location

43rd Medical Associates, P.C.

Phoenix, Arizona, 85051, United States

Location

Clinical Research Advantage, Inc.

Tempe, Arizona, 85282, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Marina Raikhel, Md, Faafp

Lomita, California, 90717, United States

Location

Richard S. Cherlin, Md

Los Gatos, California, 95032, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Family Physicians Of Greeley

Greeley, Colorado, 80634, United States

Location

Coastal Connecticut Research, Llc

New London, Connecticut, 06320, United States

Location

Central Florida Clinical Trials, Inc.

Altamonte Springs, Florida, 32701, United States

Location

Westside Center For Clinical Research

Jacksonville, Florida, 32205, United States

Location

Panhandle Family Care Associates

Marianna, Florida, 32446, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

Belzoni Clinical Research

Belzoni, Mississippi, 39038, United States

Location

R-Research

Hamilton, New Jersey, 08690, United States

Location

Internist Associates Of Central New York

Syracuse, New York, 13210, United States

Location

Southgate Medical Group

West Seneca, New York, 14224, United States

Location

Down East Medical Associates, Pa

Morehead City, North Carolina, 28557, United States

Location

James J. Brown, Md

Akron, Ohio, 44319, United States

Location

Integris Family Care South

Oklahoma City, Oklahoma, 73170, United States

Location

Southeastern Research Associates, Inc.

Taylors, South Carolina, 29687, United States

Location

Abbott Clinical Research Group, Inc

San Antonio, Texas, 78224, United States

Location

Avastra Clinical Trials

Midvale, Utah, 84047, United States

Location

Optimum Clinical Research, Inc.

Salt Lake City, Utah, 84102, United States

Location

Capital Clinical Research Center

Olympia, Washington, 98502, United States

Location

Stephen G. Danley, Do

Spokane, Washington, 99216, United States

Location

Local Institution

Calgary, Alberta, T3C 3P1, Canada

Location

Local Institution

Coquitlam, British Columbia, V3K 3V9, Canada

Location

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Winnipeg, Manitoba, R3E 3P4, Canada

Location

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Bathurst, New Brunswick, E2A 4X7, Canada

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Ajax, Ontario, L1S 7J5, Canada

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Toronto, Ontario, M9W 4L6, Canada

Location

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Waterloo, Ontario, N2T 2Z6, Canada

Location

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Drummondville, Quebec, J2B 7T1, Canada

Location

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L'Ancienne-Lorette, Quebec, G2E 2X1, Canada

Location

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Saint-Léonard, Quebec, H1S 3A9, Canada

Location

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Ahmedabad, 380 015, India

Location

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Bangalore, 560 043, India

Location

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Bangalore, 560 052, India

Location

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Jaipur, 302001, India

Location

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Jaipur, 302016, India

Location

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Durango, Durango, 34000, Mexico

Location

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Guadalajara, Jalisco, 44670, Mexico

Location

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Df, Mexico City, 11800, Mexico

Location

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Mexico City, Mexico City, 06700, Mexico

Location

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Monterrey, Nuevo León, 64060, Mexico

Location

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Veracruz, Veracruz, 91910, Mexico

Location

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Mérida, Yucatán, 97070, Mexico

Location

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Ponce, 00716, Puerto Rico

Location

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Ponce, 00717, Puerto Rico

Location

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Kursk, 305035, Russia

Location

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Saint Petersburg, 191015, Russia

Location

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Saint Petersburg, 195112, Russia

Location

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Saint Petersburg, 195257, Russia

Location

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Saint Petersburg, 197022, Russia

Location

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Saint Petersburg, 197341, Russia

Location

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Saratov, 410012, Russia

Location

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Smolensk, 214018, Russia

Location

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Benoni, Gauteng, 1501, South Africa

Location

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Soweto, Gauteng, 1818, South Africa

Location

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Paarl, Western Cape, 7646, South Africa

Location

Local Institution

Tygerberg, Western Cape, 7505, South Africa

Location

Related Publications (1)

• Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.

  PMID: 26894924 DERIVED

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Results Point of Contact

• Title: AstraZeneca
• Organization: Clinical Trial Transparency

Clinical.Trial.Transparency@astrazeneca.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: September 22, 2008
• Primary Completion: December 29, 2009
• Study Completion: December 29, 2009
• Last Updated: April 20, 2017
• Results First Posted: May 2, 2014

Record last verified: 2017-04

Locations

RU (8); ME (7); ZA (4); US (26); PR (2); IN (5); CA (10)