Use of mirabegron in overweight sugar patients not controlled with both metformin and glimepiride medicine.

Effect of mirabegron as add on therapy in overweight type 2 diabetes mellitus patients not adequately controlled with metformin and glimepiride: A randomized double blind placebo controlled trial. - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087020

Enrollment

112

Registered

2025-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Intervention1: Tab Mirabegron: Tab Mirabegron 100 mg OD for 3 months Control Intervention1: Placebo: placebo 100 mg 0D for 3 months

Eligibility

Inclusion criteria

Inclusion criteria: Patients with overweight with BMI of more than 23 and on stable therapy with metformin and glimepiride for 6 months with HbA1c between 8 to 10.5

Exclusion criteria

Exclusion criteria: Patient with type 2 diabetes mellitus on insulin. Patient with HbA1C more than 10.5% Patient with uncontrolled hypertension more than 160/110 mm Hg. Patients with elevated levels of AST and ALT more than three times the normal limit. Patients with elevated serum creatinine levels and blood urea nitrogen levels are 1.5 times higher level than the upper limit of normal. Pregnant and lactating women.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of mirabegron in achieving the glycemic targets when administered as add on therapy in overweight type 2 diabetes mellitus patients not adequately controlled with metformin and glimepiride.Timepoint: Fasting and two-hour postprandial blood glucose - baseline and every monthly visit for 3 months. HbA1c - baseline and at the end of 3 months.	—

Secondary

Measure	Time frame
To compare the changes in body weight, waist circumference, and body mass index with mirabegron and placebo as add on therapy in overweight type 2 diabetes mellitus patients not adequately controlled with metformin and glimepiride. To evaluate the effect of add on therapy of mirabegron on lipid profile in overweight type 2 diabetes mellitus patients not adequately controlled with metformin and glimepiride. To describe the adverse effects of mirabegron as add on therapy in overweight type 2 diabetes mellitus patients not adequately controlled with metformin and glimepiride. Timepoint: The body weight, waist circumference, body mass index, blood pressure, heart rate, adverse effects experienced by the patient- Baseline and every monthly visits for 3 months. total cholesterol and its fractions-baseline and at the end of months	—

Measure

Time frame

To compare the changes in body weight, waist circumference, and body mass index with mirabegron and placebo as add on therapy in overweight type 2 diabetes mellitus patients not adequately controlled with metformin and glimepiride. To evaluate the effect of add on therapy of mirabegron on lipid profile in overweight type 2 diabetes mellitus patients not adequately controlled with metformin and glimepiride. To describe the adverse effects of mirabegron as add on therapy in overweight type 2 diabetes mellitus patients not adequately controlled with metformin and glimepiride. Timepoint: The body weight, waist circumference, body mass index, blood pressure, heart rate, adverse effects experienced by the patient- Baseline and every monthly visits for 3 months. total cholesterol and its fractions-baseline and at the end of months

—

Countries

India

Contacts

Public ContactDr Manikandan S

JIPMER

rahulmbbs2.0@gmail.com8870202912

Outcome results

None listed

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