A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00162305
First received: September 9, 2005
Last updated: March 20, 2015
Last verified: March 2015
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Purpose
The purpose of this clinical research study is to assess the safety of, exposure to, and biological effects of BMS-512148 in stable Type 2 diabetic subjects
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: BMS-512148 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Placebo-controlled, Randomized, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Bms-512148 in Diabetic Subjects |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Secondary Outcome Measures:
- To assess the PK of BMS-512148 and its pharmacologically active metabolite, BMS-511926, when BMS-512148 is administered alone or concomitantly with metformin [ Time Frame: 14 days ] [ Designated as safety issue: No ]Exposure to BMS-512148 and BMS-511926
- To assess the pharmacodynamic effect of BMS-512148, administered alone or concomitantly with metformin, on serum and urine markers of glucose homeostasis [ Time Frame: 14 days ] [ Designated as safety issue: No ]Fasting and post-prandial serum glucose, serum fructosamine, serum insulin, and serum C-peptide and urinary glucose and urinary calcium
- To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on safety markers in urine [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]calcium, magnesium, sodium, potassium, phosphate, chloride, uric acid, oxalate, citrate, total protein, albumin, osmolality, deoxypyridinoline (D-pyr) cross-links, C-telopetide (CTX), N-acetyl-β- D-glucoasaminidase (NAG), and β2-microglubulin (β2-MG)
- To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on the following safety markers in serum [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Serum osteocalcin, parathyroid hormone (PTH), 25-Vitamin D, and 1,25-Vitamin D
- To assess the effect of BMS-512148 administered alone or concomitantly with metformin on the percent inhibition of renal glucose reabsorption [ Time Frame: 14 days ] [ Designated as safety issue: No ]Percent inhibition of renal glucose resorption over each 0-4 h, 4-8 h, and 8-12 h post-dose interval calculated from the amount of renally filtered glucose and the amount of glucose excreted in the urine for each collection interval.
- To assess the effects of BMS-512148 on the PK of metformin in diabetic subjects. [ Time Frame: 14 days ] [ Designated as safety issue: No ]Exposure to metformin
- To identify potential biomarkers in both urine and blood [ Time Frame: 14 days ] [ Designated as safety issue: No ]Serum and urine for metabonomic assessment
| Enrollment: | 47 |
| Study Start Date: | April 2005 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: BMS-512148
Capsules, Oral, 100 mg, Once daily, 14 days.
Other Name: Dapagliflozin
|
| Active Comparator: 2 |
Drug: BMS-512148
Capsules, Oral, 25 mg, Once daily, 14 days.
Other Name: Dapagliflozin
|
| Active Comparator: 3 |
Drug: BMS-512148
Capsules, Oral, 5 mg, Once daily, 14 days.
Other Name: Dapagliflozin
|
| Placebo Comparator: 4 |
Drug: Placebo
Capsules, Oral, 0 mg, Once daily, 14 days.
Other Name: Dapagliflozin
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Established diagnosis of Type 2 diabetes mellitus, who are treated with metformin or diet alone (drug naive).
- Fasting glucose (FG) < - 240 mg/dL, while on metformin or antidiabetic diet alone.
- HbA1c (Hemoglobin A1c) in the range of 6.0-10.0%
Exclusion Criteria:
- Women of childbearing potential
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162305
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162305
Locations
| United States, Florida | |
| Local Institution | |
| Fort Lauderdale, Florida, United States, 33301 | |
| Local Institution | |
| Miami, Florida, United States, 33169 | |
| Local Institution | |
| Orlando, Florida, United States, 32809 | |
| United States, Louisiana | |
| Local Institution | |
| New Orleans, Louisiana, United States, 70119 | |
| United States, Texas | |
| Local Institution | |
| San Antonio, Texas, United States, 78229-3894 | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
Publications:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00162305 History of Changes |
| Other Study ID Numbers: | MB102-003 |
| Study First Received: | September 9, 2005 |
| Last Updated: | March 20, 2015 |
| 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 |
ClinicalTrials.gov processed this record on September 28, 2016