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STUDY TO ASSESS EFFECT OF REMOGLIFLOZIN COMPARED TO DAPAGLIFLOZIN ON 24 HOUR GLUCOSE PROFILE ASSESSED BY CONTINUOUS GLUCOSE MONITORING IN INDIAN PATIENTS OF TYPE 2 DIABETES MELLITUS (REMIT- GV)

A PROSPECTIVE MULTICENTER RANDOMIZED OPEN LABEL, ACTIVE CONTROLLED STUDY TO ASSESS EFFECT OF REMOGLIFLOZIN COMPARED TO DAPAGLIFLOZIN ON 24 HOUR GLUCOSE PROFILE ASSESSED BY CONTINUOUS GLUCOSE MONITORING IN INDIAN PATIENTS OF TYPE 2 DIABETES MELLITUS. - REMIT-GV

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032005
Enrollment
75
Registered
2021-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Remogliflozin 100mg: 100 mg Remogliflozin Tablet twice daily to be consumed by the T2DM patients for 42 days. Control Intervention1: Dapagliflozin 10 mg: Dapagliflozin 10mg tablet to be

Sponsors

Dr Bipin Sethi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults (� 18 years) of either gender 2. Diagnosed with Type-2 Diabetes Mellitus & reported HbA1c >7.0 & 3. On stable therapy ( >6 weeks prior to screening) of Metformin monotherapy or dual therapy of Metformin+DPP4i 4. Random blood glucose levels 5. On complaint dietary regimen for >6 weeks prior to screening 6. Patients who is able to understand & willing to comply with study requirements and provide written informed consent for participation

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to study medications 2. Presence or evidence of diabetic ketosis or non-ketotic hyperosmolar coma 3. Presence of cardiac arrhythmias, acute coronary syndrome 4. Liver enzyme levels > 3 ULN 5. Estimated glomerular filtration rate (eGFR) 6. Evidence of acute infection 7. Anemia and/or using erythropoiesis stimulating agents 8. Pregnant or lactation women 9. Patient with known dietary irregular patterns 10. A patient who in opinion of investigator would not be suitable for study participation

Design outcomes

Primary

MeasureTime frame
1. Mean change from baseline in each of parameters of glycemic variability. Timepoint: 1.Baseline, Week 1, week 4 & week 6 for between the treatment arms—

Secondary

MeasureTime frame
1.Mean change from baseline in HbA1c 2.Mean change from baseline in FPG, PPG 3.Incidence of any treatment emergent adverse events in terms of abnormal signs, or laboratory reports.Timepoint: 1.From Baseline, week 6 & in between two treatment arms. 2.From baseline, week 4 & week 6 in & between two treatment arms 3.From Baseline till end of the study & in between two treatment arms.—

Countries

India

Contacts

Public ContactPranjal Ausekar

Care Hospital

sethibipin54@gmail.com7330796165

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026