A clinical study to assess the efficacy and safety of Imeglimin Tablets 1000 mg in patients with diabetes.

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2023/02/050136
• Lead Sponsor: Exemed Pharmaceuticals

Brief Summary

Thistrial is an open label, prospective, randomized, non-comparative, multicentric,phase IV clinical study to evaluate the efficacy, safety and tolerability ofImeglimin Hydrochloride Tablets 1000 mg in patients with type 2 diabetesmellitus inadequately controlled with diet and exercise alone.

 Patientswho are willing and able to participate in the study will sign and date theInformed Consent Form on the day of screening / baseline visit (Visit 1).During this screening period, patients who are willing to give consent will beevaluated for all the eligibility criteria. Eligible patients (male or female) agedbetween 18 to 65 years (both inclusive), who are on the diet and exercise therapy alone for at least 3 months priorto screening and having inadequate glycaemic control [Glycosylated Haemoglobin(HbA1c) levels of > 7.0% to ≤ 8.5%] will be considered for the study.

 After confirming the inclusion/exclusion criteria thesubject will be randomized and provided with study medication at randomizationvisit. Subjects will be provided with patient diary at randomization visit,which need to be brought along with in each subsequent visit till the lastvisit. Follow up visits will be done on week 6/day 42(±4), week 12/day 84(±4) andweek 16/day 112(±4) (Final Visit) of treatment to assess efficacy, safety andtolerability.

 Patientswill be assigned to Imeglimin Hydrochloride Tablets 1000 mg. Patients will begiven the study medication twice a day for 16 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Study Completion: 2023-10-18
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male or Female Patients aged between 18 to 65 years (both inclusive) with diagnosis of Type 2 diabetes mellitus.
• Treatment naïve patients with inadequately controlled with diet and exercise therapy alone for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of > 7.0% to ≤ 8.5%.
• 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 / baseline visit.
• Patients with no abnormality on 12-lead ECG at screening / baseline visit.
• Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
• Patients willing to comply with the protocol requirements.

Exclusion Criteria

• Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
• Patients with a history of metabolic acidosis or diabetic ketoacidosis.
• Patients with fasting plasma glucose (FPG) > 200 mg/dL at screening.
• Patients with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening.
• Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 2X the UNL) at screening.
• Patients with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
• Patients with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
• Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
• Patients with known hypersensitivity to any of the ingredients of study medication.
• Patients receiving treatment with systemic corticosteroids.
• Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
• Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
• Patients with history of any malignancy.
• Patients with known case of infection with hepatitis B, hepatitis C or HIV.
• Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening.
• Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
• Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
• Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
• Suspected inability or unwillingness to comply with the study procedures.
• Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in glycosylated haemoglobin (HbA1c) from baseline to end of the study visit (week 16).	At Screening/baseline visit, | Visit 4 [Week 12/Day 84 (±4)] and | Visit 6 [Week 16/Day 112 (±4)].

Secondary Outcome Measures

Name	Time	Method
Adverse events / serious adverse events reported	during the study.
Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 16).	At Screening/baseline visit,
Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (week 16).	At Screening/baseline visit,
Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (week 16).	At Visit 5 [Week 16/Day 112 (±4)].
Proportion of patients requiring rescue medication.	At Visit 3 [Week 6/Day 42 (±4)],
Hypoglycemic episodes during the study.	Throughout the study.
Changes in clinical laboratory parameters from	baseline to end of the study visit (week 16).

Trial Locations

Locations (6)

Aatman Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Abhayahasta Multispeciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Calcutta School of Tropical Medicine; 🇮🇳 Kolkata, WEST BENGAL, India

Jawahar Lal Nehru (J.L.N) Medical College; 🇮🇳 Ajmer, RAJASTHAN, India

Maharaja Agrasen Superspeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and CPR General Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Aatman Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Chintan B Patel

Principal investigator

9825182251

cr.aatman@gmail.com