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A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)

NCT02139943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2016-07-18

Study results available
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Summary

The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Canagliflozin 100 mg

Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.

DRUG

Canagliflozin 300 mg

Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.

DRUG

Placebo

Matching placebo capsule will be taken orally, before the first meal of the day.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT02139943 on ClinicalTrials.gov