Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: FDC of Glimepiride (1 mg/2 mg), Voglibose (0.2 mg), Metformin ER 500 mg tablets: One tablet twice daily orally for 24 weeks
Control Intervention1: FDC of Voglibose (0.2 mg / 0.3 mg), Me
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 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]
Exclusion criteria
Exclusion criteria: 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 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 Ë? 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 12 and 24Timepoint: Change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 12 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: week 12 and 24 | — |
Countries
India
Contacts
Public ContactRajesh Gaikwad
Sun Pharma Laboratories Limited
Outcome results
None listed