FindTrial
Sign In

Study to check the safety and benefits of medicine combination of Sitagliptin and Dapagliflozin in Diabetic patients

Post Approval Concurrent Observational Study to Assess Safety Clinical Utilization and Effectiveness of Sitagliptin and Dapagliflozin Combination Therapy in the treatment of Type 2 Diabetes for Extra Glycemic Advantages (SIDAXA Study) - SIDAXA STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/048488
Enrollment
18000
Registered
2022-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

None listed

Sponsors

Torrent Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female patients 18 to 59 years 2.Known T2DM cases with uncontrolled HbA1c >7 % requiring Sitagliptin and Dapagliflozin combination on top of existing therapy 3.T2DM cases with one or more additional risk factors or established CAD that is stable for >3 months following hospitalization 4.Patients willing follow-up for 12 Week at the same centre

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to SGLT2i or Metformin Extended release formulation 2.Unstable or untreated CAD with HF not receiving either ARNI or Diuretics 3.CKD with eGFR 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

Design outcomes

Primary

MeasureTime frame
1 Mean changes from baseline in glycated hemoglobin (HbA1c) level at 12 week 2 FPG and PPBG at 4 weekTimepoint: 1 Baseline (Day 0) and 12 weeks 2 Baseline (Day 0) and 4 weeks—

Secondary

MeasureTime frame
1 Proportion of participants with treatment emergent adverse event during observation period 2 Change for HbA1c in T2d cases with CAD at 12 W 3 Change in Albumin & LDL-C at 12 W 4 Change in FPG and PPBG at 4 W 5 Change in SGPT and SGOT at 12W 6 Change in BP at 4W and 12W 7 Change in Weight at 4W and 12WTimepoint: 1 Baseline (Day 0) and 12 weeks 2 Baseline (Day 0) and 12 weeks 3 Baseline (Day 0) and 12 weeks 4 Baseline (Day 0) and 4 weeks 5 Baseline (Day 0) and 12 weeks 6 Baseline (Day 0) and 12 weeks 7 Baseline (Day 0) and 4 weeks and 12 weeks—

Countries

India

Contacts

Public ContactDr Krishnaprasad K

Lina Diabetes Care and Mumbai Diabetes Research Centre

drmanojchawla@yahoo.com9820002333

Outcome results

None listed

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