A Phase IV clinical trial to evaluate the safety and efficacy of Imeglimin 500 mg and 1000 mg tablets.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/03/064846
- Lead Sponsor
- Synokem Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures.
2.Male and Female subjects of group age =18 to = 65 years.
3.Treatment naïve patients with inadequately controlled with diet and exercise therapy alone for the at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of =7.5 to = 8.5 %.
4.Type 2 diabetes (fasting glucose =126 mg/dl).
5.Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening/ base line.
1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent form.
2. Subject with positive pregnancy test as confirmed by urine dipstick test.
3. Subject who is planning to become pregnant within the study duration/lactating mothers.
4. Fasting plasma glucose > 200 mg/dl ( >15 mmol/L).
5. Type 1 diabetes and Evidence of serious diabetic complications.
6. Evidence of serious cardiovascular complications.
7. Laboratory value abnormalities as defined by the protocol.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method