Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: FDC Glimepiride, voglibose and extended release metformin hydrochloride tablets: FDC Glimepiride, voglibose and extended release metformin hydrochloride tablets
(1+0.2+500) mg
(2+0.2+5
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 4.Patients who had BMI of>=23 and 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
Exclusion criteria
Exclusion criteria: 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 ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PPBG from baseline Change in HbA1c from baseline Timepoint: Time frame 12 Weeks and 24 Weeks Time frame 12 Weeks and 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FBG 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 Evaluation of Clinical Global Impression on Improvement (CGI-I). Timepoint: (Time frame: 12 weeks and 24 weeks) [Time frame: 24 weeks] [Time frame: 24 weeks] [Time frame: 4, 12, 24 weeks] | — |
Countries
India
Contacts
Public ContactMr Guruprasad Palekar
Sun Pharma Laboratories Limited
Outcome results
None listed