Study to check the result and safety of combination treatment of vildagliptin and dapagliflozin in type 2 diabetes mellitus patient

Post Approval Concurrent Observational Study to Assess Safety Clinical Utilization and Effectiveness of Vildagliptin and Dapagliflozin Fixed Dose Combination (FDC) in the treatment of Type 2 Diabetes with Multiple Risk Factors - SUVIDA MRF - SUVIDA

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/08/044757

Enrollment

4000

Registered

2022-08-18

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: E116- Type 2 diabetes mellitus with other specified complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients 18 to 59 years 2. Known T2DM cases with uncontrolled HbA1c greater than 7 requiring Dapagliflozin or Vildagliptin SR as fixed dose combination 3. T2DM cases with one or more additional risk factors or established CAD that is stable for greater then 3 months following hospitalization 4. Patients willing follow-up for 12 W 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 less than 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 breastfeeding 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

Measure	Time frame
Change in Glycosylated Haemoglobin (Hba1c) levels from baseline to 12 weeksTimepoint: Baseline (day 0) and 12 weeks	—

Secondary

Measure	Time frame
Change for HbA1c in T2d cases with CAD at 12 WTimepoint: Baseline (Day 0) to 12 weeks ;Change in Albumin & LDL-C at 12 WTimepoint: Baseline (Day 0) to 12 weeks;Change in FPG and PPBG at 4 WTimepoint: Baseline (Day 0) to 4 week;Change in SGPT and SGOT at 12WTimepoint: Baseline (Day 0) to 12 weeks ;Proportion of participants with treatment emergent adverse event during observation periodTimepoint: Baseline (Day ) to 12 weeks	—

Measure

Time frame

Change for HbA1c in T2d cases with CAD at 12 WTimepoint: Baseline (Day 0) to 12 weeks ;Change in Albumin & LDL-C at 12 WTimepoint: Baseline (Day 0) to 12 weeks;Change in FPG and PPBG at 4 WTimepoint: Baseline (Day 0) to 4 week;Change in SGPT and SGOT at 12WTimepoint: Baseline (Day 0) to 12 weeks ;Proportion of participants with treatment emergent adverse event during observation periodTimepoint: Baseline (Day ) to 12 weeks

—

Countries

India

Contacts

Public ContactDr Shehla Shaikh

KGN DIABETES ENDOCRINOLOGY CENTRE

drshehla@rediffmail.com9820984842

Outcome results