Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Fixed dose combination Glibenclamide, Metformin, and Voglibose tablet
: Fixed dose combination Glibenclamide 5 mg, Metformin 500 mg, and Voglibose 0.2 mg tablet,
Fixed dose combin
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be considered for enrollment in the study: 1.Male or female patients aged between 18 to 65 years 2.Patients diagnosed with type 2 diabetes 3.Patients having HbA1c ratio of > 7.5 and 4.Patients having BMI of > 23 and 5.Patients having Postprandial Blood Glucose (2 hours post- meal) concentration more than 200 mg/dl 6.Patients currently on treatment with stable dose of combination of Glibenclamide 5 mg and Metformin 500 mg twice daily for at least 12 weeks before screening. 7.Subject or his legally accepted representative is willing to give informed consent
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must be excluded from enrollment in the study: 1.The patients with the history of serious hypoglycemia shall be excluded. 2.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control 3.Presence of any clinically relevant disease (e.g. Type I diabetes mellitus, severe cardiovascular disease, significant renal or hepatic impairment, diabetic coma or pre coma, acute or chronic metabolic acidosis including diabetic ketoacidosis and lactic acidosis, severe infection, serious trauma, congestive heart failure that requires treatment etc.) 4.Patients having Fasting Blood Glucose concentration more than 270 mg/dl 5.Patients received long term insulin therapy ( 6.Patients who fall into New York Heart Association (NYHA) class III or IV 7.Patients receiving Bosentan 8.Surgical or medical condition that, in the judgment of the Investigator, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used 9.Current or recent substance abuse, including alcohol 10.Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests 11.Participation in any experimental drug study within 60 days before screening 12.Subjects having intolerance, hypersensitivity or any other contraindication to any of the study products 13.Subjects judged unfit for this study by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline in Fixed dose combination Glibenclamide 5 mg, Metformin 500 mg, Voglibose 0.2 mg and in Glibenclamide 5 mg, Metformin 850 mgTimepoint: 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| I.For Fixed dose combination Glibenclamide 5 mg, Metformin 500 mg, Voglibose 0.2 mg and Glibenclamide 5 mg, Metformin 850 mg group: Change in PPBG from baseline Change in FBG from baseline Proportion of participants with HbA1c reduction of at least 0.5% at the end of 24 weeks Proportion of participants with PPBG less than 170 mg/dl at the end of 24 weeks Evaluation of CGI-I Proportion of participants with AEs and SAEs Timepoint: 12 weeks-24 weeks;II.Fixed dose combination Glibenclamide 5 mg, Metformin 500 mg, and Voglibose 0.3 mg and in Glibenclamide 5 mg, Metformin 1000 mg group: Change in PPBG from 12 weeks Change in FBG from 12 weeks Proportion of participants with HbA1c reduction of at least 0.5% at the end of 24 weeks Proportion of participants with PPBG less than 170 mg/dl at the end of 24 weeks Evaluation of CGI-I Proportion of participants with AEs and SAEs Timepoint: 12 weeks - 24 weeks | — |
Countries
India
Contacts
Public ContactGuruprasad Palekar
Sun Pharma Laboratories Limited (SPLL)
Outcome results
None listed