Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: null- Type II Diabetes Mellitus
Conditions
Interventions
Intervention1: Evogliptin: 5 mg tablets to be administered orally, once a day for 24 weeks
Control Intervention1: Sitagliptin: 100 mg tablets to be administered orally, once a day for 24 weeks
Sponsors
ALKEM LABORATORIES LTD
Eligibility
Inclusion criteria
Inclusion criteria: I1. Male/ Female Patients between 18-75 years of age. I2. Patients with type 2 diabetes mellitus, as defined by WHO, insufficiently controlled with Metformin I3. Patients on Metformin monotherapy for > (or equal to) 8 weeks on a stable dose of > (or equal to) 1 gm/ day dose of Metformin. I4. Patient willing to give written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: E1. Patients having screening HbA1c 10% E2. Patients having history of type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus. E3. History of diabetic ketoacidosis or hyperosmolar non-ketotic coma prior to screening. E4. Patients having history of pancreatitis/ pancreatic cancer E5. Patients with thyroid dysfunction i.e. TSH 4 mIU/L at screening. E6. Patients with BMI > 40 kg/m2 E7. Patients with uncontrolled hypertension at the time of screening with resting systolic or diastolic blood pressure >140 mmHg or >90 mmHg, respectively E8. History of myocardial infarction or any other major cardiovascular event in last 6 months prior to screening. E9. Patient with chronic heart failure (NYHA Class III & IV) E10. Patient with ejection fraction E11. Patients with history of malignancy excluding treated basal cell carcinoma E12. Patient with history of gastrointestintal resection E13. History of serological evidence of any infectious liver disease E14. Patients with evidence of depression or any other psychiatric illness E15. Laboratory findings measured at screening: âË?â?? Amylase and/or lipase > 3 times the upper limit of the normal laboratory range. âË?â?? Hemoglobin âË?â?? Total bilirubin > 1.5 times the upper limit of the normal laboratory range âË?â?? ALT/ AST > 2.5 times the upper limit of the normal laboratory range âË?â?? Serum creatinine more than upper limit of the normal. âË?â?? Creatinine phosphokinase (CPK) more than three times of upper limit of normal. âË?â?? Patients with uncontrolled hyperlipidemia i.e. LDL-C > (or equal to) 200 mg/d or TG >400mg/dl E16. Patients taking following medication: âË?â?? Use of corticosteroids for one week or more within 3 months prior to screening âË?â?? Any anti-diabetic treatment other than the background anti-diabetic therapy i.e. Metformin prior to screening âË?â?? Patients currently on drugs which will interfere with CYP3A4 activity: i) CYP3A4 inducers: Rifampicin, Phenytoin, Carbamezepine, Phenobarbital etc ii) CYP3A4 inhibitors: Clarithromycin, Erythromycin, Fluconazole etc âË?â?? Any Anti-HIV drugs E17. Patients with history of hypersensitivity to any component of Metformin or DPP-IV inhibitors. E18. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study. (Patient using oral contraceptives or likely to us oral contraceptive during the study will not be eligible to participate in the study) E19. Pregnant or lactating female. E20. Known history of drug or alcohol abuse within 3 months prior to the time of screening E21. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study. E22. Patient who has participated in any other clinical study in last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine change in HbA1c from baseline to week 12 in both the treatment groups.Timepoint: Baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To determine the changes in HbA1c from baseline to Week 12 & week 24 2) To determine the change from baseline in FPG at Weeks 12 & 24 3) To determine the change from baseline in PPG at Weeks 12 & 24 4) To determine HbA1c response rate i.e. % of patients achieving target HbA1c 7% at Weeks 12 & 24. 5) To determine Ã?² cell function (HOMA-Ã?²) at Weeks 12 & 24 6) To determine the changes from baseline in body weight at Weeks 2, 4, 8, 12, 16, 20 & 24. 7) To determine safety of IP.Timepoint: 1) HbA1c (Baseline to Week 12 & week 24) 2) FPG (Baseline to Week 12 & 24) 3) PPG (Baseline to Week 12 & 24). 4) HbA1c response rate (week 12 & 24) 5) Ã?² cell function (week 12 & week 24) 6) Body weight (baseline to Week 2, 4, 8, 12, 16, 20 & 24) 7) Incidence of AEs | — |
Countries
India
Contacts
Public ContactVinayaka Shahavi
Alkem Laboratories Limited
Outcome results
None listed