EVALUATION OF EFFICACY AND SAFETY OF FDC OF THREE ANTIDIABETIC DRUGS VERSUS FDC OF TWO ANTIDIABETIC DRUGS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2015/01/005408
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Efficacy and safety of FDC of Glimepiride, Voglibose and Metformin ER was determined in open label, randomized, comparative, multicentric, 29 weeks study (1 week of screening period, 4 weeks of run-in period and 24 weeks of treatment period) in 294 patients at 11 different centers across India. Patients with type 2 diabetes and fulfilling all the inclusion criteria were enrolled in the study. Two groups of patients who were receiving either fixed dose combination of Glimepiride 1 mg + Metformin ER 500 mg or fixed dose combination of Glimepiride 2 mg + Metformin ER 500 mg two times daily dose and met all inclusion the criteria and none of the exclusion criteria at screeningvisit were considered eligible for “Run-in Period†in the study.
Patients were kept on same dose (of screening) for 4 weeks in run in period after successful screening and both the groups of patients were reevaluated for eligibility criteria after 28 days. Patients who met all the inclusion criteria and none of exclusion criteria were enrolled in the study and randomized to either dual drug therapy or triple drug therapy.The dose was taken just before meal or with the first bite of each main meal. Patients on Glimepiride 1 mg + Metformin ER 500 mg twice daily group during “Run-in Period†were randomized when eligible to either receive Glimepiride 1 mg + Metformin ER 1000 mg twice daily or Glimepiride 1 mg + Voglibose 0.2 mg + Metformin ER 500 mg twice daily for 24 weeks. Patients on Glimepiride 2 mg + Metformin ER 500 mg twice daily group during “Run in Period†were randomized when eligible to either receive Glimepiride 2 mg + Metformin ER 1000 mg twice daily or Glimepiride 2 mg + Voglibose 0.2 mg + Metformin ER 500 mg twice daily for 24 weeks. Primary efficacy variables were Change in PPBG from baseline and Change in HbA1c from baseline. Secondary efficacy variables were Change in FBG from baseline, Proportion of participants with HbA1c reduction of at least 1% at the end of 24 weeks, Proportion of participants with PPBG < 170 mg/dl at the end of 24 weeks and evaluation of Clinical Global Impression on Improvement (CGI-I).
In summary, based on the study results, it is concluded that FDC of three drugs (FDC of Glimepiride 1mg + Voglibose 0.2 mg + Metformin ER 500 mg group and FDC of Glimepiride 2 mg + Voglibose 0.2 mg + Metformin ER 500 mg group) is safe and effective in patients with type 2 DM. It is especially useful in Indians, because of higher pancreatic beta-cell function, less insulin sensitive and consumption of carbohydrate as polished rice. It can also be an alternative for elderly patients and in those with hepatic impairment or mild to moderate renal function impairments in whom further increase in Metformin dose is not recommended.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
The following points were considered for inclusion criteria in this study: 1.Male or female patients who were aged between 18 years to 65 years 2.Patients who were diagnosed with type 2 diabetes 3.Patients who had HbA1c ratio of≥7.5 and≤10 4.Patients who had BMI of≥23 and≤30kg/m2 5.Patients who had postprandial blood glucose (2 hours post meal) concentration more than 200 mg/dl 6.Patients who were on treatment with stable dose of fixed dose combination of Glimepiride 1 mg + Metformin 500 mg twice daily OR fixed dose combination of Glimepiride 2 mg + Metformin 500 mg twice daily for at least 12 weeks before enrolment 7.Patients who willingly gave their informed consent.
The following points were considered for exclusion criteria in this study: 1.Pregnant, lactating women or women of childbearing age who were not willing to use an acceptable method of birth control during the study period 2.Patients who had type 1 diabetes 3.Patients who had fasting blood glucose concentration more than 270 mg/dl 4.Patients who had hypersensitivity to any of the investigational products 5.Patients who had significant renal or hepatic impairment 6.Patients who received long term insulin therapy (≤ 3 days of treatment was allowed) 7.Patients who had history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis 8.Patients who were in a state of diabetic coma or pre coma 9.Patients who had severe infection or serious trauma 10.Alcohol abused patients 11.Patients who were in New York Heart Association (NYHA) class III or IV category 12.Patients who had congestive heart failure to be treated 13.Patients who had inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption 14.Patients who were judged unfit for this study by investigator 15.Patients who were receiving Miconazole.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in PPBG from baseline Time frame 12 Weeks and 24 Weeks | Time frame 12 Weeks and 24 Weeks Change in HbA1c from baseline Time frame 12 Weeks and 24 Weeks | Time frame 12 Weeks and 24 Weeks
- Secondary Outcome Measures
Name Time Method Change in FBG Proportion of participants with HbA1c reduction of at least 1% at the end of 24 weeks
Trial Locations
- Locations (11)
Ashirwad Hospital & Research Centre
🇮🇳Mumbai, MAHARASHTRA, India
Aster Aadhar Hospital
🇮🇳Kolhapur, MAHARASHTRA, India
Deogaonkar Hospital
🇮🇳Nashik, MAHARASHTRA, India
GMERS Medical College & Hospital
🇮🇳Ahmadabad, GUJARAT, India
GMERS Medical College and General Hospital Vadodara
🇮🇳Vadodara, GUJARAT, India
IPGME & R, SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
Medical college Hospital Kolkata
🇮🇳Kolkata, WEST BENGAL, India
Osmania General Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Peerless Hospitex Hospital & Research Centre Limited
🇮🇳Kolkata, WEST BENGAL, India
Sanjeevan Hospital
🇮🇳Pune, MAHARASHTRA, India
Scroll for more (1 remaining)Ashirwad Hospital & Research Centre🇮🇳Mumbai, MAHARASHTRA, IndiaDr Shrikant V DeshpandePrincipal investigator9822017445svshrikant@gmail.com