Clinical Trial Details

Overview

Research Study Summary

Clinical Protocol MB102230

Purpose

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus.

To Learn more

CW ID: 220605
Date Last Changed: November 7, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 to 75 Years
Overall Status
Recruiting
Lead Sponsor
AstraZeneca AB, 151 85 Södertälje, Sweden Study being conducted by Bristol-Myers Squibb on behalf of AstraZeneca AB
Duration
68 Weeks
Facility Type
N/A

Eligibility

Key Inclusion Criteria:

  • Ages 18 to 75 years
  • Diagnosis of T1DM. In addition, a central laboratory C-peptide < 0.7 ng/mL (0.23 nmol/L) is required
  • Insulin use for at least 12 months prior to screening
  • HbA1c eligibility criteria include: Screening Visit: Central laboratory HbA1c 7.7% To 11.0%

Key Exclusion Criteria:

  • History of T2DM
  • Previous use of dapagliflozin and/or any other SGLT-2 inhibitors

Contact

Denise Esparza, Senior Clinical Research Coordinator
Diabetes Associates Medical Group / Clinical Research
1234 W. Chapman Ave., Suite 106
Orange, CA 92868
Phone: 714-202-8894
Fax: 714-639-3904

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