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A research project investigating at how individuals with Type 2 Diabetes Mellitus respond to the addition of Sodium-glucose Cotransporter-2(SGLT2) inhibitor drugs in terms of blood sugar levels and weight.

A Prospective Observational Study to Assess the Efficacy & Safety of Sodium-glucose Cotransporter-2(SGLT2) Inhibitors as an Add-On drug to other Oral Hypoglycemic Agents in Reducing Glycated Hemoglobin and Weight in Type 2 Diabetes Mellitus at a Tertiary Care Hospital in Jaipur. - SWAG

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/06/054440
Enrollment
90
Registered
2023-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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: SGLT 2 Inhibitors as an adjunct with OHAs: Dapaglifozin 10mg OD for 6 months Empaglifozin 10mg or 25 mg OD for 6 months Control Intervention1: Standard Treatment with Oral Hypoglycemic

Sponsors

Dr Mahima Makhija
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients >18 years of age. 2.Patients of Type 2 DM fulfilling criteria of Type 2 DM according to American Diabetes Association (ADA) guidelines. 3.Patients with Type 2 DM on other OHAs. 4.T2DM Patients with other Chronic Cardiovascular issues like HTN, Heart Failure and CAD

Exclusion criteria

Exclusion criteria: 1.Patients with eGFR 2.Pregnant females. 3.Patients not filling the criteria of Type 2 DM according to ADA guidelines. 4.Patients with other contraindications to SGLT2 Inhibitors.

Design outcomes

Primary

MeasureTime frame
1.To evaluate the efficacy of SGLT2 Inhibitors as an add-on drug to other OHAs in reducing : HBA1C (Glycated Haemoglobin) and; Weight in Type 2 DM patients. 2.To evaluate the safety of SGLT2 Inhibitors as an add-on drug to other OHAs. Timepoint: Zero Month, 3rd Month , 6th Month—

Secondary

MeasureTime frame
1. To assess the Cardio-protective effect of the SGLT 2 inhibitors and; 2. To evaluate the risk factors of Type 2 DM on the basis of History. Timepoint: Zero Month , 6 Months—

Countries

India

Contacts

Public ContactDr Prahlad Dhakar

RUHS College of Medical Sciences

alkabansal04@gmail.com9929058384

Outcome results

None listed

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