Comparative safety study of Glimepiride and Metformin in Indian patients with type 2 Diabetes Mellitus.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/12/022364
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult (>=18 years to <65 years) Indian patients of either sex with Type 2 Diabetes
2. Newly diagnosed type 2 DM subjects or subjects who are uncontrolled on Metformin/Glimepiride monotherapy with HbA1c of >=7.5% to <10.5% at the start of the treatment or within 30 days prior to consenting.
3. In the opinion of investigator, the participant is considered appropriate to receive Glimepiride along with Metformin.
4. In the opinion of investigator, the participant is unlikely to require additional antidiabetic agents (oral or parenteral) during the study.
5. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
6. Signs and dates a written, informed consent form prior to the initiation of any study procedures.
1. Abnormal clinical examination including manifestation of renal and hepatic impairment.
2. History of recurrent hypoglycaemic episodes or event of severe hypoglycaemia in past 3 months
3. Patient on current concomitant medications that may interfere with study assessment like but not limited to Corticosteroids, Thyroxine, Diuretics or alternative system of medicine e.g. Ayurvedic or Homeopathic
4. Has a history of lactic acidosis.
5. Has dehydration or gastrointestinal dysfunction such as diarrhoea or vomiting, which may cause dehydrated state.
6. Has any serious cardiac disease, any serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
7. Has a condition requiring insulin for blood glucose control (eg, severe ketosis, diabetic coma, type 1 diabetes, severe infection, pre- or post-operative condition, or serious trauma).
8. Has any malignancy.
9. Has a history of hypersensitivity or allergies to sulphonylureas or biguanides.
10. Is a habitual drinker consuming more than 100 mL of alcohol on average daily.
11. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol dependence.
12. If female, the participant is pregnant or lactating; intending to become pregnant during study period or who is sexually active with a non-sterilized male partner not consenting to routinely use adequate contraception from signing of informed consent throughout the duration of the study
13. Is considered ineligible for the study for any other reason by the investigator.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method