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A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes

NCT04288778 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2025-03-30

Study results available
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Summary

The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination.

Conditions

Interventions

DRUG

Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)

Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration. The study Treatment duration will be of 24 weeks.

Sponsors & Collaborators

  • Johnson & Johnson Private Limited

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Private Limited Clinical Trial · Johnson & Johnson Private Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2022-07-26
Completion
2022-07-26
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT04288778 on ClinicalTrials.gov