Clinical Protocol MB102230

  • STATUS
    Recruiting
  • sponsor
    AstraZeneca AB, 151 85 Södertälje, Sweden Study being conducted by Bristol-Myers Squibb on behalf of AstraZeneca AB
Updated on 25 March 2021

Summary

Clinical Protocol MB102230

Description

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.

Details
Condition Diabetes Mellitus Types I and II
Clinical Study IdentifierTX145993
SponsorAstraZeneca AB, 151 85 Södertälje, Sweden Study being conducted by Bristol-Myers Squibb on behalf of AstraZeneca AB
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

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%

Exclusion Criteria

History of T2DM
Previous use of dapagliflozin and/or any other SGLT-2 inhibitors
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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