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A Phase IV clinical trial to evaluate the safety and efficacy of Imeglimin 500 mg and 1000 mg tablets.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/064846
Enrollment
490
Registered
2024-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Imeglimin 1000 mg: Imeglimin 1000 mg Tablets once a day orally for 112 days Intervention2: Imeglimin 500 mg: Imeglimin 500 mg Tablets twice a day orally for 112 days

Sponsors

Synokem Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Mean Change in HbA1cTimepoint: from base line to Day 84 week 12.—

Secondary

MeasureTime frame
Mean Change in fasting plasma glucose from baseline to EOT (Day 112, week16). Timepoint: from base line to EOT Day 112 week 16;Mean Change in 2-hr post prandial plasma glucose (2-hr PPG) Timepoint: from baseline to EOT (Day 112, week16).;Proportion of patients achieving a therapeutic glycemic response, defined as HBA1C 7%Timepoint: at the EOT (Day 112, week16).—

Countries

India

Contacts

Public ContactMukesh Kumar

RAHE Life Science

mukesh@rahelife.com9873038019

Outcome results

None listed

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