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

December 20, 2016 updated by: AstraZeneca

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial

Study Type

Interventional

Enrollment (Actual)

631

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1012AAR
        • Local Institution
      • Buenos Aires, Argentina, C1408INH
        • Local Institution
      • Cordoba, Argentina, 5000
        • Local Institution
      • Cordoba, Argentina, X5006CBI
        • Local Institution
      • Salta, Argentina, A4406CLA
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1405BCJ
        • Local Institution
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Local Institution
      • Zarate, Buenos Aires, Argentina, 2800
        • Local Institution
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution
      • St Leonards, New South Wales, Australia, 2065
        • Local Institution
      • Woollongong, New South Wales, Australia, 2500
        • Local Institution
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 0M3
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Local Institution
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Local Institution
      • Thornhill, Ontario, Canada, L4J 8L7
        • Local Institution
      • Toronto, Ontario, Canada, M4R 2G4
        • Local Institution
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institution
    • Quebec
      • Gatineau, Quebec, Canada, J8V 2P5
        • Local Institution
      • Laval, Quebec, Canada, H7T 2P5
        • Local Institution
      • Sherbrooke, Quebec, Canada, J1G 5K2
        • Local Institution
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Local Institution
  • Denmark
      • Copenhagen Nv, Denmark, 2400
        • Local Institution
      • Gentofte, Denmark, 2820
        • Local Institution
      • Hvidovre, Denmark, 2650
        • Local Institution
  • France
      • Besancon Cedex, France, 25030
        • Local Institution
      • Brest Cedex, France, 29609
        • Local Institution
      • Paris, France, 75877
        • Local Institution
      • Paris Cedex 10, France, 75475
        • Local Institution
      • Poitiers Cedex, France, 86021
        • Local Institution
  • India
      • Bangalore, India, 560 052
        • Local Institution
      • Bangalore, India, 560034
        • Local Institution
      • Chennai, India, 600029
        • Local Institution
      • Pune, Maharashtra, India, 411011
        • Local Institution
      • Rajasthan, India, 302 001
        • Local Institution
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452001
        • Local Institution
    • Maharashtra
      • Pune, Maharashtra, India, 411 004
        • Local Institution
  • Italy
      • Chieri, Italy, 10023
        • Local Institution
      • Chieti Scalo, Italy, 66013
        • Local Institution
      • Modena, Italy, 41100
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Perugia, Italy, 06126
        • Local Institution
      • Pisa, Italy, 56126
        • Local Institution
      • Roma, Italy, 00189
        • Local Institution
      • Siena, Italy, 53100
        • Local Institution
  • Mexico
      • Durango, Mexico, 34075
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Mexico, 11800
        • Local Institution
      • Df, Distrito Federal, Mexico, 01120
        • Local Institution
      • Df, Distrito Federal, Mexico, 06700
        • Local Institution
    • Guanajuato
      • Celaya, Guanajuato, Mexico, 38000
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Local Institution
  • Peru
      • Arequipa, Peru
        • Local Institution
      • Lima, Peru, 18
        • Local Institution
      • Lima, Peru, LIMA 13
        • Local Institution
    • Lima
      • Cercado De Lima, Lima, Peru, 1
        • Local Institution
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Local Institution
      • San Juan, Puerto Rico, 00909
        • Local Institution
  • Singapore
      • Singapore, Singapore, 119074
        • Local Institution
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution
      • San Sebastian De Los, Spain, 28702
        • Local Institution
      • Vizcaya, Spain, 48903
        • Local Institution
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Vista Medical Research, Inc.
    • California
      • Fresno, California, United States, 93720
        • Valley Research
      • Greenbrae, California, United States, 94904
        • Marin Endocrine Care & Research, Inc.
      • Los Gatos, California, United States, 95032
        • Office Of Richard Cherlin, Md
      • Northridge, California, United States, 91325
        • Diabetes Medical Center Of California
      • Riverside, California, United States, 92505
        • Apex Research of Riverside
      • Torrance, California, United States, 90502
        • La Biomed At Harbor Ucla Med Ctr.
    • Colorado
      • Denver, Colorado, United States, 80220
        • Endocrine Associates Of The Rockies
    • Florida
      • Marianna, Florida, United States, 32446
        • Panhandle Family Care Associates
      • Tampa, Florida, United States, 33614
        • Genesis Clinical Research
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Twin Cities Clinical Research
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kcva Medical Center Research Svc (151)
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Va Nebraska-Western Iowa Health Care System (Nwihcs)
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • University of Medicine and Dentistry of New Jersey
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hartford, New York, United States, 13413
        • Slocum-Dickson Medical Group, Pllc
    • Ohio
      • Akron, Ohio, United States, 44319
        • Community Health Care Of Manchester
      • Beachwood, Ohio, United States, 44122
        • Center For Thyroid Diseases And Endocrinology
      • Zanesville, Ohio, United States, 43701
        • Physician Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Univ Of Oklahoma Health Science Center
    • Oregon
      • Medford, Oregon, United States, 97504
        • Rogue Valley Clinical Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Internal Medicine Of Sc, Pa
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Health Specialists
      • Summerville, South Carolina, United States, 29485
        • Palmetto Clinical Research
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Institute of Dallas
      • Houston, Texas, United States, 77005
        • Westbury Medical Clinic P.A.
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • The Strelitz Diabetes Center
    • Washington
      • Olympia, Washington, United States, 98502
        • Capital Clinical Research Center
      • Tacoma, Washington, United States, 98405
        • Cedar Research Llc
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Advanced Healthcare
      • Milwaukee, Wisconsin, United States, 53295
        • Zablocki Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Tablets, Oral, 0 mg, Once Daily, 104 weeks
ACTIVE_COMPARATOR: Dapagliflozin (10 mg)
Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once Daily, 104 weeks
Other Names:
  • BMS-512148
Drug: Dapagliflozin
Tablets, Oral, 5 mg, Once Daily, 104 weeks
Other Names:
  • BMS-512148
ACTIVE_COMPARATOR: Dapagliflozin (5 mg)
Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once Daily, 104 weeks
Other Names:
  • BMS-512148
Drug: Dapagliflozin
Tablets, Oral, 5 mg, Once Daily, 104 weeks
Other Names:
  • BMS-512148

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]
Time Frame: From Baseline to Week 24
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
Time Frame: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
Time Frame: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (ESTIMATE)

April 22, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2017

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB102-029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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