Observational study to check the effectiveness and safety of Remoglifozin in high risk patients with type 2 Daibetes Mellitus.

Not Applicable

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

• Registration Number: CTRI/2022/01/039072
• Lead Sponsor: Torrent Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male or female patients 18 to 59 years.

2. Known T2DM cases with uncontrolled HbA1c >7 % requiring or receiving Remogliflozin etabonate for not more than two weeks

3. T2DM cases with one or more additional risk factors or established CVD that is stable for >3 months following hospitalization

4.Patients willing follow-up for 24 W at the same centre.

Exclusion Criteria

1. Hypersensitivity to SGLT2i or Metformin Extended release formulation

2. Unstable or untreated CVD with HF not receiving either ARNI or Diuretics

3. CKD with eGFR <45 ml/min

4. Hepatic enzyme elevation X3 ULN

5. DKA and/or history or prior use of Dapagliflozin or Canagliflozin or Empagliflozin

6. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding

7. Type 1 diabetes mellitus patients

8. Sexually active woman of childbearing age not practicing accepted birth control method

9. Urinary tract infection or acute pyelonephritis in the 30 days prior to study entry

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean changes from baseline in glycated hemoglobin (HbA1c) level at 12 WTimepoint: Mean changes from baseline in glycated hemoglobin (HbA1c) level at 12 W

Secondary Outcome Measures

Name	Time	Method
1. Proportion of participants with treatment emerging adverse events during observational period. <br/ ><br>2. Change of HbA1c in T2d cases with more than or is equal to 1 additional risk factor at 12 W. <br/ ><br>3. Change of HbA1c in in T2d cases with CVD at 12 W. <br/ ><br>4. Change in SBP and DBP at 12W and 24 W. <br/ ><br>5. Change in PPBG at 12W.Timepoint: At 12 W and 24 W.