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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

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

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

NCT ID

Therapeutic Area

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

Tablets, Oral, 5 mg, Once Daily, 104 weeks

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

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Marin Endocrine Care & Research, Inc.

Office Of Richard Cherlin, Md

Low Country Internal Medicine Of Sc, Pa

Carolina Health Specialists

Cedar Research Llc

Aurora Advanced Healthcare

Apex Research Of Riverside

Twin Cities Clinical Research

Vista Medical Research, Inc.

Genesis Clinical Research

Valley Research

Local Institution

The Strelitz Diabetes Center

Research Institute Of Dallas

Winthrop University Hospital

Capital Clinical Research Center

Rogue Valley Clinical Research

Univ Of Oklahoma Health Science Center

Thomas Jefferson University

Drexel University College Of Medicine

Panhandle Family Care Associates

Kcva Medical Center Research Svc (151)

La Biomed At Harbor Ucla Med Ctr.

Va Nebraska-Western Iowa Health Care System (Nwihcs)

Zablocki Veterans Affairs Medical Center

Palmetto Clinical Research

Diabetes Medical Center Of California

Slocum-Dickson Medical Group, Pllc

Endocrine Associates Of The Rockies

University Of Medicine And Dentistry Of New Jersey

Westbury Medical Clinic P.A.

Community Health Care Of Manchester

Physician Research, Inc.

Endocrine Research Solutions, Inc.

Center For Thyroid Diseases And Endocrinology

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

Age Continuous

Age, Customized

Gender, Customized

Race/Ethnicity, Customized

Weight

Study Specific Characteristic

Pre-Enrollment Anti-Hyperglycemic Therapy

All randomized participants who received at least 1 dose of study medication

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.

All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)

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

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

All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)

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

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.

All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)

Arms	Assigned Interventions
Active Comparator: Dapagliflozin (10 mg)	Drug: Dapagliflozin Tablets, Oral, 10 mg, Once Daily, 104 weeks Other Name: BMS-512148
Active Comparator: Dapagliflozin (5 mg)	Drug: Dapagliflozin Tablets, Oral, 5 mg, Once Daily, 104 weeks Other Name: BMS-512148
Placebo Comparator: Placebo	Drug: Placebo Tablets, Oral, 0 mg, Once Daily, 104 weeks

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Publication

Publication long-term

MB102029_Redacted_CSR_synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator