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

NCT01498185 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2017-02-10

Study results available
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Summary

To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Dapagliflozin

Tablets, Oral, 1 mg, Once daily, 14 days

DRUG

Placebo matching Dapagliflozin

Tablets, Oral, 0 mg, Once daily, 14 days

Sponsors & Collaborators

  • Astra Zeneca, Bristol-Myers Squibb

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01498185 on ClinicalTrials.gov