single drug vs double drug in new diabetic adults.

A Randomised Open Label Study on the efficacy and safety of Metformin Monotherapy vs Metformin- Dapagliflozin combination therapy in the treatment of newly diagnosed type 2 diabetic patients in the urban population of chennai

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052868

Enrollment

200

Registered

2023-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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: METFORMIN AND DAPAGLIFLOZIN: oral tablet Metformin 500 mg twice daily after food, morning and evening for 6 months oral tablet dapagliflozin 10 mg once daily in the morning after food

Eligibility

Inclusion criteria

Inclusion criteria: newly diagnosed type 2 diabetes mellitus with HbA1C more than 6.5 % associated with hypertension, obesity, hyperlipidemia.

Exclusion criteria

Exclusion criteria: age less than 35 and more than 55 type 1 diabetes mellitus hypertensives, hyperlipidemics renal or hepatic disease pregnancy lactation

Design outcomes

Primary

Measure	Time frame
hbA1CTimepoint: 3rd month, 6th month, 12th month	—

Secondary

Measure	Time frame
fasting blood sugar, post prandial blood sugar, lipid profile, BP, waist circumference ratio , urine routine QOL(quality of life) indexTimepoint: baseline, 6th month(investigations) QOL at 6th month and 12th month	—

Countries

India

Contacts

Public ContactDr B KALAISELVI

ACS medical college and hospital, DR MGR EDUCATIONAL AND RESEARCH INSTITUTE

drbkalaiselvi@gmail.com9840311021

Outcome results

None listed

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