A clinical study to evaluate the safety and efficacy of Imeglimin Tablets in diabetes patients.

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. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/03/107198

Enrollment

490

Registered

2026-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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 Tablets 500 mg: Patients will be advised to take two tablets in the morning and two tablets in the evening orally, swallowed with water around same time every day for 112 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject who agrees for giving informed consent and provide signed and dated written IEC or IRB approved Informed Consent Form prior to initiation of any study procedures. 2. Male and Female subjects of group age Greater than or equal to 18 to Less than or equal to 65 years. 3. Treatment na ve 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 Greater than or equal to 7.5 to Less than or equal to 8.5 Percentage. 4. Type 2 diabetes of fasting glucose Greater than or equal to 126 mg per dL. 5. Women of childbearing potential must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening or base line.

Exclusion criteria

Exclusion criteria: 1. Subjects who are not able to or not willing to sign an IRB or 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 or lactating mothers. 4. Fasting plasma glucose Greater than 200 mg per dL. 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

Measure	Time frame
Mean Change in HbA1c from base line to day 84, Week 12.Timepoint: Baseline and Week 12 (Day 84).	—

Secondary

Measure	Time frame
Mean change in fast plasma glucose from baseline to EOTTimepoint: Baseline, Week 2 (Day 14), Week 6 (Day 42), Week 12 (Day 84) and Week 16 (Day 112).;Mean change in 2hrs post prandial plasma glucose (2hrs PPG) from baseline to EOT.Timepoint: Baseline, Week 2 (Day 14), Week 6 (Day 42), Week 12 (Day 84) and Week 16 (Day 112).;Proportion of patients achieving a Therapeutics glycemic response defined as HbA1C 7 percent at the day 84, Week 12.Timepoint: Week 12 (Day 84). ;Safety assessments such as Serum Lipid Profile (Triglycerides, HDL and LDL), LFT and RFT (BUN, Serum Creatinine and eGFR) from base line and EOT (Day 112, Week 16).Timepoint: Baseline and Week 16 (Day 112).;The number of adverse events will be documented to evaluate the safety profile of study drugs from baseline to EOT (Day 112, Week 16).Timepoint: Throughout the Study.	—

Measure

Time frame

Mean change in fast plasma glucose from baseline to EOTTimepoint: Baseline, Week 2 (Day 14), Week 6 (Day 42), Week 12 (Day 84) and Week 16 (Day 112).;Mean change in 2hrs post prandial plasma glucose (2hrs PPG) from baseline to EOT.Timepoint: Baseline, Week 2 (Day 14), Week 6 (Day 42), Week 12 (Day 84) and Week 16 (Day 112).;Proportion of patients achieving a Therapeutics glycemic response defined as HbA1C 7 percent at the day 84, Week 12.Timepoint: Week 12 (Day 84). ;Safety assessments such as Serum Lipid Profile (Triglycerides, HDL and LDL), LFT and RFT (BUN, Serum Creatinine and eGFR) from base line and EOT (Day 112, Week 16).Timepoint: Baseline and Week 16 (Day 112).;The number of adverse events will be documented to evaluate the safety profile of study drugs from baseline to EOT (Day 112, Week 16).Timepoint: Throughout the Study.

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Countries

India

Contacts

Public ContactDr Aditya Kaushik

Synokem Pharmaceuticals Ltd.

aditya.kaushik@synokempharma.com9818637035

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026