Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
AstraZeneca
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00976495
First received: September 11, 2009
Last updated: January 6, 2011
Last verified: January 2011
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Purpose
The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Dapagliflozin Drug: Placebo Drug: Hydrochlorothiazide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Basic Science |
| Official Title: | An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic and Blood Pressure (BP) Control |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Glomerular Filtration Rate as measured by plasma clearance of non-radioactive iohexol [ Time Frame: After 12 weeks of double-blind oral administration ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Ambulatory blood pressure. Red cell mass measured by dilution of radioisotopically tagged erythrocytes & plasma volume (PV) measured by dilution of radioisotopically labeled human serum albumin. RCM&PV measured in subset of subjects (part of a substudy) [ Time Frame: After 12 weeks of double-blind oral administration ] [ Designated as safety issue: Yes ]
| Enrollment: | 75 |
| Study Start Date: | October 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dapagliflozin |
Drug: Dapagliflozin
Tablets, Oral, 10 mg, once daily, 12 weeks
Other Name: BMS-512148
Drug: Placebo
Tablets, Oral, 0 mg, once daily, 12 weeks
|
| Active Comparator: Hydrochlorothiazide |
Drug: Hydrochlorothiazide
Tablets, Oral, 25 mg, once daily, 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 6.6 and ≤ 9.5%
- Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the enrollment visit
- Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and < 165 mmHg, AND/OR diastolic BP (DBP) ≥ 80 and < 105 mmHg
- C-peptide ≥ 0.8 ng/mL
- Estimated GFR by the Modification of Diet in Renal Disease (MDRD) formula > 60 mL/min/1.73m² and < 150 mL/min/1.73m²
- Urine albumin:creatinine ratio (UACR) < 300 mg/g
- BMI ≤ 45.0 kg/m2
Exclusion Criteria:
- Administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either ACEI or ARB), at any dose during the 12 weeks prior to the enrollment visit
- History of adverse reaction to radio-contrast dye
- Allergy or contraindication to use of thiazide diuretics
- Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN)
- Alanine aminotransferase (ALT) > 3X ULN
- Serum Total Bilirubin > 1.5X ULN
- Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976495
Locations
| United States, California | |
| Advanced Clinical Res Inst | |
| Anaheim, California, United States, 92801 | |
| Torrance Clinical Research | |
| Lomita, California, United States, 90717 | |
| United States, Florida | |
| Elite Research Institute | |
| Miami, Florida, United States, 33169 | |
| Orlando Clinical Research Center | |
| Orlando, Florida, United States, 32809 | |
| Compass Research, Llc | |
| Orlando, Florida, United States, 32806 | |
| United States, Michigan | |
| University Of Michigan | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| Prism Research | |
| St. Paul, Minnesota, United States, 55114 | |
| United States, Rhode Island | |
| Memorial Hospital Of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, Wisconsin | |
| Zablocki Veterans Affairs Medical Center | |
| Milwaukee, Wisconsin, United States, 53295 | |
| Canada, Ontario | |
| Local Institution | |
| Toronto, Ontario, Canada, M4G 3E8 | |
| Canada, Quebec | |
| Local Institution | |
| Laval, Quebec, Canada, H7T 2P5 | |
| Netherlands | |
| Local Institution | |
| Groningen, Netherlands, 9713 GZ | |
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00976495 History of Changes |
| Other Study ID Numbers: | MB102-035, EUDRACT #: 2009-010221-39 |
| Study First Received: | September 11, 2009 |
| Last Updated: | January 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hydrochlorothiazide Diuretics Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013