BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes
Study identifier:MB102-072
ClinicalTrials.gov identifier:NCT01498185
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Explore the Safety, Pharmacokinetics and Pharmacodynamics of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus
Medical condition
Type 1 Diabetes Mellitus
Phase
Phase 2
Healthy volunteers
No
Study drug
Dapagliflozin, Placebo matching Dapagliflozin
Sex
All
Actual Enrollment
171
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Feb 2012
Primary Completion Date: 01 Oct 2012
Study Completion Date: 01 Oct 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2016 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Astra Zeneca, Bristol-Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: Dapagliflozin (1 mg) | Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days |
| Experimental: Arm 2: Dapagliflozin (2.5 mg) | Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days |
| Experimental: Arm 3: Dapagliflozin (5 mg) | Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days |
| Experimental: Arm 4: Dapagliflozin (10 mg) | Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days Drug: Dapagliflozin Tablets, Oral, 1 mg, Once daily, 14 days |
| Experimental: Arm 5: Placebo matching Dapagliflozin | Drug: Placebo matching Dapagliflozin Tablets, Oral, 0 mg, Once daily, 14 days |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
