| Trial ID: | L6693 |
| Source ID: | NCT04288778
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| Associated Drug: |
Canagliflozin + Metformin Hydrochloride (Fixed Dose Combination)
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| Title: |
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
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT04288778/results
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| Conditions: |
Diabetes Mellitus
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| Interventions: |
DRUG: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)
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| Outcome Measures: |
Primary: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. TEAEs were defined as events that started on or after the study medication start date and time., Baseline (Day 1) up to 24 weeks|Percentage of Participants With Unexpected Adverse Events (AEs), An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An adverse event was considered unexpected if the nature or severity was not consistent with the applicable product reference safety information., Baseline (Day 1) up to 24 weeks|Percentage of Participants With Adverse Drug Reactions (ADRs), ADRs were defined as the treatment related TEAEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were defined as events that started on or after the study medication start date and time., Baseline (Day 1) up to 24 weeks | Secondary: Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24, Percent change from baseline in HbA1c at Weeks 12 and 24 was reported., Baseline, Weeks 12 and 24
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| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Private Limited
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
276
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2020-11-25
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| Completion Date: |
2022-07-26
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| Results First Posted: |
2023-08-18
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| Last Update Posted: |
2025-03-30
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| Locations: |
Lifecare Hospital and Research Centre, Bengaluru, 560092, India|Post Graduate Institute of Medical Education And Research PGIMER, Chandigarh, 160012, India|Kovai Diabetes Specialty Centre & Hospital, Coimbatore, 641 009, India|Excelcare Hospitals (A unit of Asclepius Hospitals and Health Care Pvt. Ltd.), Guwahati, 781033, India|Thumbay Hospital New life / Endocrinology, Hyderabad, 500024, India|Fortis Hospital, Mohali, 160062, India|Jehangir Clinical Development Center Pvt Ltd, Pune, 411001, India|Chellaram Diabetes Institute, Pune, 411021, India|Nirmal Hospital Pvt. Ltd., Surat, 395002, India|Jothydev's Diabetes Research Centre, Trivandrum, 695032, India
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| URL: |
https://clinicaltrials.gov/show/NCT04288778
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