CTRI/2020/11/029080 [Registered on: 12/11/2020] Trial Registered Prospectively
Last Modified On:
29/11/2022
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 Study to Assess Efficacy and Safety of Fixed Dose Combination of Glimepiride, Voglibose and Metformin Tablets in Comparison to Dual – Combination of Anti-Diabetic Drug in Patients with Type 2 Diabetes Mellitus.
Scientific Title of Study
A Multicenter, Randomized, Comparative Study to Assess Efficacy and Safety of Fixed Dose Combination of Glimepiride, Voglibose and Metformin Tablets in Comparison to Dual – Combination of Anti-Diabetic Drug in Patients with Type 2 Diabetes Mellitus
Department of Medicine , B.J. Medical college & Civil hospital, Asarwa, Ahmedabad- 380016,Gujarat,India Ahmadabad GUJARAT
9924643700
sheetalobgy@gmail.com
Dr Brij Mohan
Brij Medical centre Pvt Ltd
Brij Medical centre Pvt Ltd., 94-E Near Panki police Station, Panki, Kanpur, UP-208020 Kanpur Nagar UTTAR PRADESH
9415043742
drbrijmohanbmc@gmail.com
Dr Alok Kanungo
Dr. Alok Kanungo’s Diabetic Center
Dr. Alok Kanungo’s Diabetic Center, 2nd floor, JB Coporate , N4/345, Nayapalli, Bhubaneswar- 751015, Odisha, India. Khordha ORISSA
9437055740
Kanungokids@gmail.com
Dr S Vasanth Kumar
Gandhi Hospital
Inpatient Block no. 03 department of general Medicine, Gandhi Hospital Musheerabad, Secunderabad, Telangana- 500003 Hyderabad TELANGANA
9160860777
Vasanth.suram@gmail.com
Dr Vidhale Tushar Ashok
Grant Govt. Medical College & Sir J.J. Group of Hospital
OPD. 20 , Department od Medicine , OPD Building , Grant Govt. Medical College & Sir J.J. Group of Hospital, Byculla Mumbai 400 008- Maharashtra India Mumbai MAHARASHTRA
8971697969
tusharvidhale@hotmail.com
Dr Balamurugan Ramanathan
Kovai Diabetes Speciality Centre and Hospital
Kovai Diabetes Speciality Centre and Hospital No. 15, Vivekananda Road, Ram Nagar, Coimbatore- 641009, Tamil Nadu. Coimbatore TAMIL NADU
9842244881
rbmkdsc@gmail.com
Dr Micky Patel
Lotus Multispeciality Hospital
Lotus Multispeciality Hospital, Block N, Krupa Residency, Motera Stadium Road, Motera- Sabarmati, Ahmedabad-380005, Gujarat, India. Ahmadabad GUJARAT
9909007305
lotushospital.79@gmail.com
Dr Sandeep Kumar Gupta
M.V. Hospital and Research Centre
M.V. Hospital and Research Centre, 314/30, Mirza Mandi, Chowk , Lucknow-226003, Uttar Pradesh, India. Lucknow UTTAR PRADESH
9336077839
sandeepkumar.gupta@rediffmail.com
Dr K Neelaveni
Osmania General Hospital
Osmania General Hospital, Osmania Medical College Afzalgunj, Hyderabad- 500012, Telengana, India Hyderabad TELANGANA
Department of Endocrinology, SMS Medical College and attached hospital, Jaipur- 302004 Jaipur RAJASTHAN
9760190799
drsanjaysaran@gmail.com
Dr Arya Vivek Vedprakash
Smt. NHL Medical College and SVP Institute Of Medical Sciences & Research
A-1, First floor General medicine, SVP Hospital, Smt. NHL Medical College and SVP Institute Of Medical Sciences & Research, Ellisbridge, Ahmedabad, 380006. Ahmadabad GUJARAT
9879537973
vivekarya007@yahoo.com
Dr Bharat Das
Sparsh Hospital & Critical Care Private Limited
A/407, Back Side of Kalyan Jewellers, Sahid Nagar, Bhubaneswar, Odisha- 751007 Khordha ORISSA
1. Patients of either sex, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
2. Patients with confirmed documented diagnosis of type 2 diabetes.
3. Patients, along with diet and exercise control, additionally on treatment with stable daily dose of Metformin 1000 mg for at least 12 weeks prior to enrolment
4. Patients with HbA1c between ≥ 7.5 to ≤ 9 %
5. Women of childbearing potential having a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence)
[Note: Woman with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal]
6. A female patient of non-childbearing potential such as (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
[Note: Post-menopausal woman are defined as: Women not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age]
ExclusionCriteria
Details
1. Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes (e.g. sulfonamide).
2. Patients who were taking anti-diabetic drugs other than study drug at the time of screening or planned to take during the study (metformin was allowed).
3. Patients receiving Miconazole.
4. Patients with Fasting Blood Glucose (FBG) > 270 mg/dl at enrolment
5. Patients with Postprandial Blood Glucose (2-hour post meal) concentration ≤ 200 mg/dL at screening
6. Patients diagnosed with type 1 diabetes.
7. Patients with significant renal (eGFR below 45 mL/min/1.73 m2) or hepatic impairment (AST and ALT ˃ 3 x ULN).
8. Patients with history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis.
9. Patients in a state of diabetic coma or pre coma.
10. Any condition (e.g. infection, trauma, surgery) which require insulin therapy at the time of screening or during the study period.
11. Patients with New York Heart Association (NYHA) class III or IV.
12. Patients with inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption.
13. Patients with any clinically significant condition as assessed by the investigator.
14. Any condition that, in the opinion of the investigator, would have compromised the well-being of the patient or the conduct of the study, or prevented the patient from meeting or performing study requirements.
15. Patients with BMI > 35 kg/m2
16. Pre-planned surgery or medical procedure that would have interfered with the conduct of the study
17. Patient with known alcohol or other substance abuse within last one year as per DSM -5 criteria.
18. Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.
19. Pregnant, lactating women or women of childbearing age who were not willing to use an acceptable method of birth control during the study period.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 12 and 24
Change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 12 and 24
Change in Postprandial Blood Glucose (PPBG) from baseline at the end of week 12 and 24
Change in Fasting Blood Glucose (FBG) from baseline at the end of week 12 and 24
Proportion of Participants Achieving HbA1c less than 7.0% at week 12 and 24
Proportion of patients requiring rescue medications
Proportion of patients requiring hypoglycemia management
Safety assessment includes Treatment Emergent Adverse Events (TEAEs) assessment during the study
week 12 and 24
Target Sample Size
Total Sample Size="399" Sample Size from India="399" Final Enrollment numbers achieved (Total)= "399" Final Enrollment numbers achieved (India)="399"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Phase IV, three
arms, multicenter, comparative, open label study. The study will be conducted
at approximately 18-20 number of centers in India, having qualified
Investigators. The study will be initiated only after the receipt of regulatory
and ethics committee (EC) approval. After obtaining the informed consent, patients
will be screened by undergoing various assessments as mentioned in Schedule of
Assessment (Appendix I). After confirming the eligibility, patients will be
randomized by allotting the randomization number. The randomized patient will
take the study medication for 24 weeks (Treatment period). Patients will be
randomized in 1:1:1 ratio in either Fixed Dose Combination of Glimepiride +
Voglibose + Metformin ER arm or Dual combination of Voglibose + Metformin arm
or Dual combination of Glimepiride + Metformin arm. Further, dose titration
will be done if the HbA1c assessment is found > 7.5 % at week 12. The
up-titrated patients will continue on the titrated dose till week 24 and
patients that do not undergo up-titration will continue on pervious drug combination
till week 24. During the study, assessments will be performed as mentioned in
Schedule of Assessment (Appendix I).