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.
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2020/11/029080
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
This is a Phase IV, threearms, multicenter, comparative, open label study. The study will be conductedat approximately 18-20 number of centers in India, having qualifiedInvestigators. The study will be initiated only after the receipt of regulatoryand ethics committee (EC) approval. After obtaining the informed consent, patientswill be screened by undergoing various assessments as mentioned in Schedule ofAssessment (Appendix I). After confirming the eligibility, patients will berandomized by allotting the randomization number. The randomized patient willtake the study medication for 24 weeks (Treatment period). Patients will berandomized in 1:1:1 ratio in either Fixed Dose Combination of Glimepiride +Voglibose + Metformin ER arm or Dual combination of Voglibose + Metformin armor Dual combination of Glimepiride + Metformin arm. Further, dose titrationwill be done if the HbA1c assessment is found > 7.5 % at week 12. Theup-titrated patients will continue on the titrated dose till week 24 andpatients that do not undergo up-titration will continue on pervious drug combinationtill week 24. During the study, assessments will be performed as mentioned inSchedule of Assessment (Appendix I).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 399
- Patients of either sex, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
- Patients with confirmed documented diagnosis of type 2 diabetes.
- 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.
- [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].
- Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes (e.g. sulfonamide).
- 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).
- Patients receiving Miconazole.
- 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.
- Patients with significant renal (eGFR below 45 mL/min/1.73 m2) or hepatic impairment (AST and ALT ˃ 3 x ULN).
- Patients with history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis.
- Patients in a state of diabetic coma or pre coma.
- Any condition (e.g. infection, trauma, surgery) which require insulin therapy at the time of screening or during the study period.
- Patients with New York Heart Association (NYHA) class III or IV.
- Patients with inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption.
- Patients with any clinically significant condition as assessed by the investigator.
- 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.
- 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.
- 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.
- Pregnant, lactating women or women of childbearing age who were not willing to use an acceptable method of birth control during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (14)
B.J. Medical college & Civil hospital
🇮🇳Ahmadabad, GUJARAT, India
Brij Medical centre Pvt Ltd
🇮🇳Nagar, UTTAR PRADESH, India
Dr. Alok Kanungo’s Diabetic Center
🇮🇳Khordha, ORISSA, India
Gandhi Hospital
🇮🇳Hyderabad, TELANGANA, India
Grant Govt. Medical College & Sir J.J. Group of Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Kovai Diabetes Speciality Centre and Hospital
🇮🇳Coimbatore, TAMIL NADU, India
Lotus Multispeciality Hospital
🇮🇳Ahmadabad, GUJARAT, India
M.V. Hospital and Research Centre
🇮🇳Lucknow, UTTAR PRADESH, India
Osmania General Hospital
🇮🇳Hyderabad, TELANGANA, India
Shivam Hospital
🇮🇳Ahmadabad, GUJARAT, India
Scroll for more (4 remaining)B.J. Medical college & Civil hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Kartikeya ParmarPrincipal investigator9924643700sheetalobgy@gmail.com