| CTRI Number |
CTRI/2023/02/050136 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess the efficacy and safety of Imeglimin Tablets 1000 mg in patients with diabetes. |
|
Scientific Title of Study
|
“An Open Label, Prospective, Randomized, Non-comparative, Multicentric, Phase IV Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Imeglimin Hydrochloride Tablets 1000 mg in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise Alone.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/2022/41, Version No.: 00 and Dated Nov 07, 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38, Kamala Prasanna Nagar, Near Ramalayam Temple, Kukatpally, Hyderabad.
Hyderabad
TELANGANA
500072
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38, Kamala Prasanna Nagar, Near Ramalayam Temple, Kukatpally, Hyderabad.
TELANGANA
500072
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mihir Upadhyay |
| Designation |
Manager - Regulatory Affairs |
| Affiliation |
Exemed Pharmaceuticals |
| Address |
Exemed Pharmaceuticals,
Plot No. 133/1 & 133/2, GIDC, Selvas Road, Vapi.
Valsad
GUJARAT
396195
India |
| Phone |
7405490368 |
| Fax |
|
| Email |
mihir.upadhyay@exemedpharma.com |
|
|
Source of Monetary or Material Support
|
| Exemed Pharmaceuticals, Plot No. 133/1 & 133/2, GIDC, Selvas Road, Vapi-396195, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Exemed Pharmaceuticals |
| Address |
Plot No. 133/1 & 133/2, GIDC, Selvas Road, Vapi-396195, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chintan B Patel |
Aatman Hospital |
# 5, Anveshan Row House, Bopal Gam BRTS, Bopal-Ghuma Road, Bopal, Ahmedabad-380058.
Ahmadabad
GUJARAT |
9825182251
cr.aatman@gmail.com |
| Dr Sagorika Mullick |
Abhayahasta Multispeciality Hospital |
Research Room, 347 by 247, 2nd Cross, Kaggadasapura Main Road, CV Raman Nagar, Bengaluru-560093.
Bangalore
KARNATAKA |
9653433664
cr.abhayahasta@gmail.com |
| Dr Arindam Naskar |
Calcutta School of Tropical Medicine |
Department of Endocrinology,
Government of West Bengal, 108, Chittranjan Avenue,
Calcutta-700073.
Kolkata
WEST BENGAL |
9874749626
dr.arindam83@gmail.com |
| Dr Sanjiv Maheshwari |
Jawahar Lal Nehru (J.L.N) Medical College |
Department of Medicine, Kala Bagh, Ajmer-305001.
Ajmer
RAJASTHAN |
9460479888
doctor.sanjiv@gmail.com |
| Dr Prabhat Kumar Sharma |
Maharaja Agrasen Superspeciality Hospital |
Room No. 109, Basement, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039.
Jaipur
RAJASTHAN |
9983995050
pksharma.clinical@gmail.com |
| Dr Vijaykumar Bhagwan Barge |
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and CPR General Hospital |
Department of Medicine, Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416002.
Kolhapur
MAHARASHTRA |
8080328480
rcsmgmc.research@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee, Calcutta School of Tropical Medicine |
Approved |
| Institutional Ethics Committee, Aatman Hospital |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2) |
Approved |
| Sri Durgamba Independent Ethics Committee - Abhayahasta Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Imeglimin Hydrochloride Tablets 1000 mg |
Patients will be advised to take one tablet twice a day orally, swallowed with water in the morning and evening around same time every day for 16 weeks. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female Patients aged between 18 to 65 years (both inclusive) with diagnosis of Type 2 diabetes mellitus.
2. 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%.
3. 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.
4. Patients with no abnormality on 12-lead ECG at screening / baseline visit.
5. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
6. Patients willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
2. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
3. Patients with fasting plasma glucose (FPG) > 200 mg/dL at screening.
4. 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.
5. 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.
6. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
7. 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.
8. Patients with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
9. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
10. Patients with known hypersensitivity to any of the ingredients of study medication.
11. Patients receiving treatment with systemic corticosteroids.
12. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
13. 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).
14. Patients with history of any malignancy.
15. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
16. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening.
17. 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.
18. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
19. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
20. Suspected inability or unwillingness to comply with the study procedures.
21. 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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 16). |
At Screening/baseline visit,
Visit 3 [Week 6/Day 42 (±4)],
Visit 4 [Week 12/Day 84 (±4)] and
Visit 5 [Week 16/Day 112 (±4)]. |
| 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,
Visit 3 [Week 6/Day 42 (±4)],
Visit 4 [Week 12/Day 84 (±4)] and
Visit 5 [Week 16/Day 112 (±4)]. |
| 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)],
Visit 4 [Week 12/Day 84 (±4)] and
Visit 5 [Week 16/Day 112 (±4)]. |
| Hypoglycemic episodes during the study. |
Throughout the study. |
Adverse events / serious adverse events reported
during the study. |
Throughout the study. |
Changes in clinical laboratory parameters from
baseline to end of the study visit (week 16). |
At Screening/baseline visit and
Visit 5 [Week 16/Day 112 (±4)]. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "210"
Final Enrollment numbers achieved (India)="210" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/03/2023 |
| Date of Study Completion (India) |
18/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
trial is an open label, prospective, randomized, non-comparative, multicentric,
phase IV clinical study to evaluate the efficacy, safety and tolerability of
Imeglimin Hydrochloride Tablets 1000 mg in patients with type 2 diabetes
mellitus inadequately controlled with diet and exercise alone.
Patients
who are willing and able to participate in the study will sign and date the
Informed Consent Form on the day of screening / baseline visit (Visit 1).
During this screening period, patients who are willing to give consent will be
evaluated for all the eligibility criteria. Eligible patients (male or female) aged
between 18 to 65 years (both inclusive), who are on the diet and exercise therapy alone for at least 3 months prior
to 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 the
subject will be randomized and provided with study medication at randomization
visit. Subjects will be provided with patient diary at randomization visit,
which need to be brought along with in each subsequent visit till the last
visit. Follow up visits will be done on week 6/day 42(±4), week 12/day 84(±4) and
week 16/day 112(±4) (Final Visit) of treatment to assess efficacy, safety and
tolerability.
Patients
will be assigned to Imeglimin Hydrochloride Tablets 1000 mg. Patients will be
given the study medication twice a day for 16 weeks. |