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

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

Collaborators

Astra Zeneca, Bristol-Myers Squibb

Inclusion and exclusion criteria

Location

Jasper Clinic, Inc.

Kalamazoo, MI, United States, 49007

Location

Dallas Diabetes & Endocrine Center

Dallas, TX, United States, 75230

Location

Va San Diego Healthcare System

San Diego, CA, United States, 92161

Location

Compass Research Phase 1, Llc

Orlando, FL, United States, 32806

Location

La Biomed Research Inst. At Harbor Ucla Med Ctr.

Torrance, CA, United States, 90502

Location

Kansas City University Of Medicine And Biosciences

Kansas City, MO, United States, 64106

Location

Regional Medical Clinic-Endocrinology

Rapid City, SD, United States, 57701

Location

Louisiana Research Associates, Inc.

New Orleans, LA, United States, 70114

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

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
MB102072_Clinical_Study_Protocol
Download
Publication
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Bristol-Myers Squibb

BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes

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

Jasper Clinic, Inc.

Dallas Diabetes & Endocrine Center

Va San Diego Healthcare System

Compass Research Phase 1, Llc

La Biomed Research Inst. At Harbor Ucla Med Ctr.

Kansas City University Of Medicine And Biosciences

Regional Medical Clinic-Endocrinology

Louisiana Research Associates, Inc.

Documents available

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

MB102072_Clinical_Study_Protocol

Publication

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator