A Multi-centric, Open label, Randomized, Non-Comparative, Two-Arm, Phase IV clinical trial to evaluate the safety and efficacy of Imeglimin 500 mg and 1000 mg tablets in the treatment of patients diagnosed with type-II diabetes mellitus in adequate control of diet and exercise alone. - IME

Synokem Pharmaceuticals Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•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.

发起方

Synokem Pharmaceuticals Limited