Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

NCT00663260 | Completed Phase 2 Results DMC

• 1 other identifier: MB102-029
• Study Type: interventional
• Target: 631
• Locations: 13 countries
• Sites: 96

Brief Summary

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]

  HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication 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 measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.

  From Baseline to Week 24

Secondary Outcomes (2)

• Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

  From Baseline to Week 24

• Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

  From Baseline to Week 24

Study Arms (3)

Dapagliflozin (10 mg)

ACTIVE COMPARATOR

Drug: Dapagliflozin

Dapagliflozin (5 mg)

ACTIVE COMPARATOR

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dapagliflozin DRUG

Tablets, Oral, 10 mg, Once Daily, 104 weeks

Also known as: BMS-512148

Dapagliflozin (10 mg)

Placebo DRUG

Tablets, Oral, 0 mg, Once Daily, 104 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
• Clinical diagnosis of moderate renal impairment

You may not qualify if:

• AST and /or ALT \> 3.0 times the upper limit of normal
• Serum total bilirubin \> 1.5 times ULN
• Symptoms of severely uncontrolled diabetes
• Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (96)

Vista Medical Research, Inc.

Mesa, Arizona, 85206, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Marin Endocrine Care & Research, Inc.

Greenbrae, California, 94904, United States

Location

Office Of Richard Cherlin, Md

Los Gatos, California, 95032, United States

Location

Diabetes Medical Center Of California

Northridge, California, 91325, United States

Location

Apex Research Of Riverside

Riverside, California, 92505, United States

Location

La Biomed At Harbor Ucla Med Ctr.

Torrance, California, 90502, United States

Location

Endocrine Associates Of The Rockies

Denver, Colorado, 80220, United States

Location

Panhandle Family Care Associates

Marianna, Florida, 32446, United States

Location

Genesis Clinical Research

Tampa, Florida, 33614, United States

Location

Endocrine Research Solutions, Inc.

Roswell, Georgia, 30076, United States

Location

Twin Cities Clinical Research

Brooklyn Center, Minnesota, 55430, United States

Location

Kcva Medical Center Research Svc (151)

Kansas City, Missouri, 64128, United States

Location

Va Nebraska-Western Iowa Health Care System (Nwihcs)

Omaha, Nebraska, 68105, United States

Location

University Of Medicine And Dentistry Of New Jersey

Voorhees Township, New Jersey, 08043, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Slocum-Dickson Medical Group, Pllc

New Hartford, New York, 13413, United States

Location

Community Health Care Of Manchester

Akron, Ohio, 44319, United States

Location

Center For Thyroid Diseases And Endocrinology

Beachwood, Ohio, 44122, United States

Location

Physician Research, Inc.

Zanesville, Ohio, 43701, United States

Location

Univ Of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Rogue Valley Clinical Research

Medford, Oregon, 97504, United States

Location

Drexel University College Of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Low Country Internal Medicine Of Sc, Pa

Charleston, South Carolina, 29406, United States

Location

Carolina Health Specialists

Myrtle Beach, South Carolina, 29572, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Research Institute Of Dallas

Dallas, Texas, 75231, United States

Location

Westbury Medical Clinic P.A.

Houston, Texas, 77005, United States

Location

The Strelitz Diabetes Center

Norfolk, Virginia, 23510, United States

Location

Capital Clinical Research Center

Olympia, Washington, 98502, United States

Location

Cedar Research Llc

Tacoma, Washington, 98405, United States

Location

Aurora Advanced Healthcare

Milwaukee, Wisconsin, 53209, United States

Location

Zablocki Veterans Affairs Medical Center

Milwaukee, Wisconsin, 53295, United States

Location

Local Institution

Buenos Aires, Buenos Aires, C1012AAR, Argentina

Location

Local Institution

Buenos Aires, Buenos Aires, C1408INH, Argentina

Location

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Capital Federal, Buenos Aires, C1405BCJ, Argentina

Location

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Mar del Plata, Buenos Aires, 7600, Argentina

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Zárate, Buenos Aires, 2800, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Córdoba, Córdoba Province, X5006CBI, Argentina

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Salta, Salta Province, A4406CLA, Argentina

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Camperdown, New South Wales, 2050, Australia

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St Leonards, New South Wales, 2065, Australia

Location

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Woollongong, New South Wales, 2500, Australia

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Launceston, Tasmania, 7250, Australia

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Calgary, Alberta, T3B 0M3, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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Barrie, Ontario, L4M 7G1, Canada

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Thornhill, Ontario, L4J 8L7, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M4R 2G4, Canada

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Gatineau, Quebec, J8V 2P5, Canada

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Laval, Quebec, H7T 2P5, Canada

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Sherbrooke, Quebec, J1G 5K2, Canada

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Regina, Saskatchewan, S4P 0W5, Canada

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Copenhagen Nv, 2400, Denmark

Location

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Gentofte Municipality, 2820, Denmark

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Hvidovre, 2650, Denmark

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Besançon, 25030, France

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Brest, 29609, France

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Paris, 75475, France

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Paris, 75877, France

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Poitiers, 86021, France

Location

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Indore, Madhya Pradesh, 452001, India

Location

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Pune, Maharashtra, 411 004, India

Location

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Bangalore, 560 052, India

Location

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Bangalore, 560034, India

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Chennai, 600029, India

Location

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Pune, Maharashtra, 411011, India

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Rajasthan, 302 001, India

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Chieri, 10023, Italy

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Chieti Scalo, 66013, Italy

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Modena, 41100, Italy

Location

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Padua, 35128, Italy

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Perugia, 06126, Italy

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Pisa, 56126, Italy

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Roma, 00189, Italy

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Siena, 53100, Italy

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Durango, Durango, 34075, Mexico

Location

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Celaya, Guanajuato, 38000, Mexico

Location

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Guadalajara, Jalisco, 44670, Mexico

Location

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Df, Mexico City, 01120, Mexico

Location

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Df, Mexico City, 06700, Mexico

Location

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Df, Mexico City, 11800, Mexico

Location

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Monterrey, Nuevo León, 64460, Mexico

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Arequipa, Arequipa, Peru

Location

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Lima, Lima Province, 18, Peru

Location

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Lima, Lima Province, LIMA 13, Peru

Location

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Lima Cercado, Lima region, 1, Peru

Location

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Caguas, 00725, Puerto Rico

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San Juan, 00909, Puerto Rico

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Singapore, 119074, Singapore

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Barcelona, 08036, Spain

Location

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San Sebastian de Los, 28702, Spain

Location

Local Institution

Vizcaya, 48903, Spain

Location

Related Publications (3)

• Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

  PMID: 38770818 DERIVED

• Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjostrom CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15. No abstract available.

  PMID: 27306615 DERIVED

• Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.

  PMID: 24067431 DERIVED

Related Links

• Publication
• Publication long-term
• MB102029\_Redacted\_CSR\_synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Anna Maria Langkilde
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2011
• Last Updated: February 10, 2017
• Results First Posted: February 10, 2017

Record last verified: 2016-12

Locations

ES (3); AU (4); AR (8); CA (10); IN (7); ME (7); DK (3); PR (2); SG (1); US (34); PE (4); FR (5); IT (8)