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A study to evaluate whether adding Alpha Lipoic Acid to Metformin and Dapagliflozin improves blood sugar control in people with Type 2 Diabetes

Comparative evaluation of Alpha Lipoic Acid as an add on therapy with Metformin Dapagliflozin on insulin resistance and endothelial dysfunction in Type 2 Diabetes Mellitus patients: An open label Randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113900
Enrollment
70
Registered
2026-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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: Alpha Lipoic Acid plus Metformin Dapagliflozin: Participants will receive Tablet Alpha Lipoic Acid 600 mg orally once daily after food in addition to Tablet Metformin 500 mg and Dapagli

Sponsors

SRM Medical College Hospital and Research Centre SRM Institute of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with Type 2 Diabetes Mellitus. HbA1c greater than 6.3 percent and less than 7.4 percent. Type 2 Diabetes Mellitus patients without hypertension and dyslipidemia. Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients with renal failure. Patients with liver failure. Pregnant or lactating women. Patients with psychiatric illness. Age greater than 60 years. Patients unwilling to provide written informed consent.

Design outcomes

Primary

MeasureTime frame
Change in glycated hemoglobin HbA1c from baseline to 16 weeksTimepoint: Baseline to 16weeks—

Secondary

MeasureTime frame
Change in malondialdehyde MDA as a marker of oxidative stress and endothelial dysfunction Change in quality of life assessed using the Short Form 36 questionnaireTimepoint: baseline to 16weeks—

Countries

India

Contacts

Public ContactDr. S. Nagaraj

SRM Medical College Hospital and Research Centre

sathyanv@srmist.edu.in9384633405

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026