Comparative study of efficacy, safety and patient compliance of Dapagliflozin(anti diabetic drug) and Metformin(anti diabetic drug) Vs Vildagliptin(anti diabetic drug) and Metformin combination therapy in newly diagnosed Type 2 diabetes patients

Comparative study of efficacy, safety and patient compliance of Dapagliflozin and Metformin Vs Vildagliptin and Metformin combination therapy in newly diagnosed Type 2 diabetes patients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/030147

Enrollment

180

Registered

2020-12-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: Dapagliflozin and Metformin: Anti Diabetic Drug in newly diagnosed Type 2 diabetes patients Control Intervention1: Vildagliptin and Metformin: Anti Diabetic Drug in newly diagnosed Type

Eligibility

Inclusion criteria

Inclusion criteria: 1)Newly diagnosed T2DM patients with or without metformin therapy 2)HbA1C >=7.5 3)Age 18-75 yrs

Exclusion criteria

Exclusion criteria: 1)Type 1DM, Patient taking metformin 1000mg/day with poor glycemic control 2)eGFR 3)CHF 4)Pregnancy 5)Lactation 6)Patients with Child bearing potential 7)Active Malignancy 8)Chronic inflammatory disorders 9)Chronic alcoholism 10)History of pancreatitis

Design outcomes

Primary

Measure	Time frame
Change in HbA1C level after 24 weeks of treatment. Timepoint: After 24 weeks of treatment.	—

Secondary

Measure	Time frame
1)Body weight 2)Anthropometric measurements (Hip circumference, Hip-Waist ratio) 3)Blood Pressure (SBP DBP) 4)ECG 5)FPG in mg/dl 6)Change in lipid profile (Total plasma Cholesterol, LDL,VLDL,HDL,Triglycerides) 7)Serum Uric acid 8)NAFLD fibrosis score (NFS) 9)Quality of life (DTR-QOL score) using DTR-QOL questionnaire. 10)Occurrence of Adverse events (Relative risk) Timepoint: After 24 weeks of treatment.	—

Measure

Time frame

1)Body weight 2)Anthropometric measurements (Hip circumference, Hip-Waist ratio) 3)Blood Pressure (SBP DBP) 4)ECG 5)FPG in mg/dl 6)Change in lipid profile (Total plasma Cholesterol, LDL,VLDL,HDL,Triglycerides) 7)Serum Uric acid 8)NAFLD fibrosis score (NFS) 9)Quality of life (DTR-QOL score) using DTR-QOL questionnaire. 10)Occurrence of Adverse events (Relative risk) Timepoint: After 24 weeks of treatment.

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Countries

India

Contacts

Public ContactKumar Gautam

kalinga institute of medical sciences

drmrmishra@gmail.com9338816676

Outcome results

None listed

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