A clinical study to Evaluate the Safety and Efficacy of FDC containing Orlistat and Metformin with Metformin alone in Obese Type II Diabetic Patients.

A Multicentric, Comparative Controlled, Open Label, Randomized, Parallel-Group, Phase III Study to Evaluate the Safety and Efficacy of FDC containing Orlistat and Metformin with Metformin alone in Obese Type II Diabetic Patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/01/002334

Enrollment

200

Registered

2012-01-12

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: null- Obese patients with Type II diabetes

Interventions

Intervention1: Orlistat 60mg + Metformin 500mg: Tablet Thrice daily just before meal for 28 days. Control Intervention1: Metformin 500mg: Tablet Thrice daily just before meal for 28 days.

Eligibility

Inclusion criteria

Inclusion criteria: i) Male and female patients in the age group of 20-80 years ii) Females of childbearing potential should have a negative pregnancy test at the pre-study visit and agree to use contraception during the study. iii) Patients willing to give informed consent. iv) Mild to moderate obese Type 2 diabetic patient. v) Patients who are willing to comply with all study requirements

Exclusion criteria

Exclusion criteria: i) Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits). ii) Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment. iii) Women who are pregnant, breast feeding or have the intention of becoming pregnant during their participation in the study. iv) Women of childbearing potential who are not using effective and medically acceptable methods of contraception. v) Patients who are meeting any of the contraindications of the study medication

Design outcomes

Primary

Measure	Time frame
Changes in fasting blood sugar level from baseline at 4 weeks between combination of Orlistat (60 mg) and Metformin (500 mg) with only Metformin (500 mg)Timepoint: 28 days	—

Secondary

Measure	Time frame
1. The percentage change change in BMI prior to therapy initiation to 4 weeks of the study 2. The percentage change in Body weight prior to therapy initiation to 4 weeks of the study 3. The percentage change in waist-hip girth prior to therapy initiation to 4 weeks of the study 4. The percentage change in Lipid profile (HDL, LDL, T Cholesterol, Triglycerides) prior to therapy initiation to 4 weeks of the study Timepoint: 28 days	—

Measure

Time frame

1. The percentage change change in BMI prior to therapy initiation to 4 weeks of the study 2. The percentage change in Body weight prior to therapy initiation to 4 weeks of the study 3. The percentage change in waist-hip girth prior to therapy initiation to 4 weeks of the study 4. The percentage change in Lipid profile (HDL, LDL, T Cholesterol, Triglycerides) prior to therapy initiation to 4 weeks of the study Timepoint: 28 days

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Countries

India

Contacts

Public ContactDr Vanita Sabhait

tkpal12@gmail.com9830036297

Outcome results

None listed

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