Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Sitagliptin, Glimepiride and Extended Release Metformin Hydrochloride Tablets: One tablet of Sitagliptin 100 mg, Glimepiride 1 mg and Extended Release Metformin Hydrochloride 1000 mg, t
Sponsors
Sun Pharma Laboratories Ltd SPLL
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adult patients of either sex who are ready to give written informed consent to participate in the study. 2) Patients with type 2 diabetes. 3) Patients on stable total daily dose of Glimepiride 2 mg & Metformin Hydrochloride Extended Release/Sustained Release/Prolonged Release 1500 mg or 2000 mg for at least 10 weeks prior to screening 4) Patients with glycosylated haemoglobin (HbA1c) >= 8% and 5) Patients with body mass index (BMI) 6) Women of childbearing potential must have 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.
Exclusion criteria
Exclusion criteria: 1) Patients with Fasting Blood Glucose (FBG) >= 270 mg/dL at screening 2) Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes. 3) Patients taking any therapy for diabetes, other than Glimepiride 2 mg and Metformin Hydrochloride ER/SR/PR 1500 mg or 2000 mg during 10 weeks prior to screening. 4) Patients with history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). 5) Patients diagnosed with type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes. 6) Patients having significant renal or hepatic impairment. 7) Patients having history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis or hyperosmolar state (including coma) within the past 6 months. 8) Any condition which require insulin therapy at the time of screening or during the study period. 9) Any weight loss medications within 3 months prior to randomization 10) Patients with New York Heart Association (NYHA) class III or IV 11) Patients with history of myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, stroke or transient ischemic attack within past 6 months 12) Patients with history of unstable angina within the past 3 months. 13) Patients with history of sustained and clinically relevant ventricular arrhythmia. 14) Patients having history or currently suffering with severe and disabling arthralgia 15) Patients having history or currently suffering with bullous pemphigoid requiring hospitalization and taking DPP-4 inhibitors 16) Patients with inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption. 17) Any of the following electrocardiogram (ECG) abnormalities: • Second or third degree atrioventricular block (AV) block without a pacemaker • Long QT syndrome or QTc > 500 ms 18) Patients with any clinically significant laboratory abnormalities/condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements. 19) Pre-planned surgery or medical procedure that would interfere with the conduct of the study 20) Patients with known alcohol or other substance abuse within last one year. 21) 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. 22) Pregnant, lactating women or women of childbearing age not willing to use an acceptable method of birth control during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in HbA1c from baseline at the end of Week 16Timepoint: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change in FBG from baseline at the end of Weeks 12, 16, 24 and 28Timepoint: Weeks 12, 16, 24 and 28;Mean Change in HbA1c from baseline at the end of Week 28Timepoint: Week 28;Mean Change in PPBG from baseline at the end of Weeks 12, 16, 24 and 28Timepoint: Weeks 12, 16, 24 and 28;Number of patients requiring hypoglycaemia managementTimepoint: Throughout the study;Number of patients requiring rescue medicationsTimepoint: Throughout the study;Proportion of Participants Achieving HbA1c less than 7.0% at Weeks 12, 16, 24 and 28Timepoint: Weeks 12, 16, 24 and 28;Safety assessment includes Treatment Emergent Adverse Events (TEAEs) assessment during the studyTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactRajesh Gaikwad
Sun Pharma Laboratories Limited
Outcome results
None listed