At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 276 enrolled
Drug / intervention
Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)drug
Likely dose
Canagliflozin + Metformin hydrochloride (Fixed Dose Combination) 50 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-centric, Open-label, Single-arm, Phase 4 Study to Evaluate the Safety and Efficacy of Canagliflozin + Metformin Hydrochloride IR Fixed-dose Combination as an Adjunct to Diet and Exercise to Improve Glycemic Control in Indian Adult Patients With Type 2 Diabetes Mellitus When Treatment With Both Canagliflozin and Metformin is Appropriate
In Brief
A Phase 4 clinical trial evaluating Canagliflozin + Metformin hydrochloride (Fixed Dose Combination) for Diabetes Mellitus. Completed, enrolled 276 participants across 10 sites.
Detailed Summary
The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesIndia
Collaborators--
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
First PostedFeb 2020
Enrollment StartNov 2020
Primary CompletionJul 2022
TodayJul 2026
First PostedFeb 28, 2020
Enrollment StartNov 25, 2020
Primary CompletionJul 26, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.3 years ago
Interventions
Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)drug
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.