CTRI/2021/03/032103 [Registered on: 18/03/2021] Trial Registered Prospectively
Last Modified On:
29/04/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A clinical trial to study the efficacy and safety of fixed dose combination of Glimepiride plus Voglibose plus Metformin Tablets in the treatment of type 2 diabetes mellitus.
Scientific Title of Study
"An Open Label, Prospective, Randomized, Comparative, Multicenter and Phase IV Clinical Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Glimepiride plus Voglibose plus Metformin Tablets in Patients with Type 2 Diabetes Mellitus".
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CRPL/CT/20/006
Protocol Number
Version No.: 00 and Dated Nov 12, 2020
Other
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr A Gopal Rao
Designation
Associate Professor
Affiliation
Government Medical College & Government General Hospital (Old RIMSGGH)
Address
Department of Medicine,
Government Medical College & Government General Hospital (Old RIMSGGH),
Srikakulam-532001.
Srikakulam ANDHRA PRADESH 532001 India
Phone
8942279033
Fax
Email
drgopalraoa@gmail.com
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.I.G: 19, H. No. 1-9-25/19,
4th Floor, Above Karur Vysya Bank, Dr. A.S. Rao Nagar, Hyderabad-500062.
Hyderabad TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd., H.I.G: 19, H. No. 1-9-25/19, 4th
Floor, Above Karur Vysya Bank, Dr. A.S. Rao Nagar, Hyderabad-
500062.
Department of Clinical Research,
Kovelamudivari Street, Suryaraopet, Vijayawada-520002. Krishna ANDHRA PRADESH
7794022370
drcresearch@gmail.com
Dr Vipul Khandelwal
Apex Hospitals Private Limited
Department of Clinical Research,
SP-4 & 6, Malviya Industrial Area,
Near Apex Circle,
Malviya Nagar,
Jaipur-302017. Jaipur RAJASTHAN
9829193517
dr.vipul@yahoo.co.in
Dr Swapnav Borthakur
Down Town Hospital
Department of Clinical Research,
Down Town Hospital,
Dispur, G.S. Road,
Guwahati-781006. Kamrup ASSAM
9864038704
swapnav.borthakur@gmail.com
Dr Solanki Dipakkumar Becharlal
Dr. M. K. Shah Medical College & Research Centre & SMT S.M.S Multispecialty Hospital
Department of Medicine,
Near Tapovan Circle,
Visat - Gandhinagar Highway, Chandkheda, Ahmedabad-382424. Ahmadabad GUJARAT
9909961231
drdeepaksolanki3@gmail.com
Dr J Naganna
Gandhi Medical College / Hospital
In Patient Block, 5th Floor, Department of General Medicine,
Gandhi Medical College / Hospital, Musheerabad, Secunderabad-500003. Hyderabad TELANGANA
9666345120
nagan99@gmail.com
Dr A Gopal Rao
Government Medical College & Government General Hospital (Old RIMSGGH)
Department of Clinical Research,
Government Medical College & Government General Hospital (Old RIMSGGH), Srikakulam-532001. Srikakulam ANDHRA PRADESH
8942279033
drgopalraoa@gmail.com
Dr Vinayak Maruti Sawardekar
Grant Government Medical College
Department of Clinical Research,
J J Marg, Byculla, Mumbai-400008. Mumbai MAHARASHTRA
9820747703
vinayaks1812@gmail.com
Dr Mahendra Pal Singh
GSVM Medical College
Post Graduate Department of Medicine, Swaroop Nagar,
Kanpur-208002. Kanpur Nagar UTTAR PRADESH
8765379671
drmahendrapalsingh@gmail.com
Dr Ved Prakash
Indira Gandhi Institute of Medical Sciences (IGIMS)
Department of Endocrinology,
Sheikhpura,
Patna-800014. Patna BIHAR
9472008685
vedprakashims@gmail.com
Dr Sanjiv Maheshwari
Jawahar Lal Nehru (J.L.N) Medical College
Department of Medicine,
Kala Bagh, Ajmer-305001. Jaipur RAJASTHAN
9460479888
doctor.sanjiv@gmail.com
Dr Prabhat Kumar Sharma
Maharaja Agrasen Superspeciality Hospital
Department of Clinical Research,
Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039. Jaipur RAJASTHAN
9983995050
agrasenhospital2003@gmail.com
Dr Raja Bhattacharya
Medical College and Hospital
Department of Medicine,
Medical College and Hospital, Kolkata, MCH Building,
4th Floor, 88 College Street, Kolkata-700073. Kolkata WEST BENGAL
9477305539
rbrbhattacharya@gmail.com
Dr Vijaykumar Shivajirao Patil
Prakash Institute of Medical Sciences & Research (PIMS & R))
Department of Clinical Research,
Islampur-Sangali Road, Islampur, Tal-Walwa, Dist-Sangali-415409. Sangli MAHARASHTRA
9371877555
prakashmc.research@gmail.com
Dr Vijaykumar Bhagwan Barge
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College
Department of Clinical Research,
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital,
Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416002. Kolhapur MAHARASHTRA
8080328480
rscmgmc.research@gmail.com
Dr Sagar Vivek Redkar
Redkar Hospital and Research Centre
Department of Clinical Research,
Mumbai-Goa Highway, Oxelbag, Dhargal, Tal-Pernem, Goa-403513. North Goa GOA
9158592177
cromgoa@gmail.com
Dr Mohan Kumar Singh
W Pratiksha Hospital
Department of Clinical Research, Golf Course Ext. Road, Sushant Lok II,
Sector 56, Gurugram-122011. Gurgaon HARYANA
North East Healthcare Private Limited, W Pratiksha Hospital
Approved
Prakash Medical College Institutional Ethics Committee
Submittted/Under Review
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2)
Submittted/Under Review
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
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
FDC of Glimepiride 1 mg plus Voglibose 0.2 mg plus Metformin Hydrochloride ER 500 mg Tablets;
FDC of Glimepiride 2 mg plus Voglibose 0.2 mg plus Metformin Hydrochloride ER 500 mg Tablets
Patients will be advised to take one tablet two times daily just before the meal (or with the first bite of each main meal), for 24 weeks.
Comparator Agent
FDC of Voglibose 0.2 mg plus Metformin 500 mg Tablets;
FDC of Voglibose 0.3 mg plus Metformin 500 mg Tablets;
FDC of Glimepiride 1 mg plus Metformin 500 mg Tablets;
FDC of Glimepiride 2 mg plus Metformin 500 mg Tablets
Patients will be advised to take one tablet two times daily just before the meal (or with the first bite of each main meal), for 24 weeks.
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).
2. Patients with confirmed documented diagnosis of type 2 diabetes mellitus.
3. Patients, along with diet and exercise control, additionally on treatment with stable daily dose of Metformin 1000 mg for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels between ≥ 8.0 to ≤ 10.0%.
4. Patients with fasting blood glucose ≤ 270 mg/dL at screening visit.
5. Patients with postprandial blood glucose (2 hours post meal) concentration > 200 mg/dL at screening visit.
6. 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.
7. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
8. Patients willing to comply with the protocol requirements.
ExclusionCriteria
Details
1. Patients with intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or drugs of similar class.
2. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
3. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
4. Patients with the Body Mass Index (BMI) < 18.5 and / or > 29.9 kg/m2 at screening visit.
5. 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.
6. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL) at screening.
7. Patients receiving Miconazole.
8. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
9. 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.
10. Patients with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
11. Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
12. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
13. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
14. 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).
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 90 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. 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
Permuted block randomization, fixed
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit (24 weeks).
Visit 1 (Baseline / Day -7), Visit 4 (Week 12 / Day 84) and Visit 6 (Week 24 / Day 168).
Secondary Outcome
Outcome
TimePoints
Mean change in fasting blood glucose (FBG) and 2-hr post prandial blood glucose (2-hr PPBG) from baseline to end of the study visit (24 weeks).
Visit 1 (Baseline / Day -7), Visit 3 (Week 6 / Day 42), Visit 4 (Week 12 / Day 84), Visit 5 (Week 18 / Day 126) and Visit 6 (Week 24 / Day 168).
Proportion of patients achieving HbA1c 7.0% at week 12 and week 24.
Visit 4 (Week 12 / Day 84) and Visit 6 (Week 24 / Day 168).
Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.
Visit 3 (Week 6 / Day 42), Visit 4 (Week 12 / Day 84), Visit 5 (Week 18 / Day 126) and Visit 6 (Week 24 / Day 168).
Changes in clinical laboratory parameters from baseline to end of the study visit (24 weeks).
Visit 1 (Baseline / Day -7) and Visit 6 (Week 24 / Day 168).
Target Sample Size
Total Sample Size="339" Sample Size from India="339" Final Enrollment numbers achieved (Total)= "355" Final Enrollment numbers achieved (India)="355"
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, three arm, comparative,
multicenter and phase IV clinical study.
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 were on diet and exercise control, additionally on treatment with
stable daily dose of Metformin 1000 mg for at least 3 months, fasting blood
glucose levels ≤ 270 mg/dL, postprandial blood glucose levels > 200 mg/dL
and having inadequate glycemic control defined as HbA1c levels between ≥ 8.0 to
≤ 10.0% at screening visit 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 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(±2), week
12/day 84(±2), week 18/day 126(±2) and week 24/day 168(±2) (Final Visit) of
treatment to assess efficacy and safety.
Patients will be
assigned to either of the three arms i.e. Arm A or Arm B or Arm C consisting of
FDC of Glimepiride 1 mg + Voglibose 0.2 mg + Metformin Hydrochloride ER 500 mg
Tablets or FDC of Voglibose 0.2 mg + Metformin 500 mg Tablets or FDC of
Glimepiride 1 mg + Metformin 500 mg Tablets. At Week 12/Day 84, If the fasting
blood glucose (FBG) assessment report is > 200 mg/dL, patients should be up
titrated to further dose. Patients will be given the study medication twice
daily for 24 weeks.