Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Vildagliptin: Vildagliptin 100 mg Sustained Release Tablet Study drug will be administered orally once daily from day 1 to day 84
Control Intervention1: Sitagliptin: Sitagliptin 100 mg
Sponsors
USV Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients of >18 years of age diagnosed with type 2 diabetes using American Diabetes Association Criteria; Treated with metformin monotherapy at a stable dose (=1,000 mg per day) for at least one month before randomization. 2.Patients who are willing to comply with continues glucose monitoring system will be included in CGMS group. 3.Patients who are uncontrolled on metformin with HbA1c of >7%. 4.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol-specific procedures are performed. 5.Patients with body mass index (BMI) 18.0 to 35.0 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Type-1 diabetes mellitus. 2. Patients who are on more than two oral anti-diabetic drugs or on insulin. 3. Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg). 4. Symptomatic heart failure. 5. Severe hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels more than three times the normal upper limit). 6. Patients with known hypersensitivity to Vildagliptin or Metformin HCl or Sitagliptin to any of the excipients. 7. Patients with severe renal impairment. 8. Patients with acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis, with or without coma. 9. Subjects who are pregnant or are currently breast-feeding. 10. Patient who is an employee of the Investigator or the Institution, or a patient who has direct involvement with the trial or other trials under the direction of the Investigator. 11. Patient who has been treated with other investigational agent or devices within the previous 30 days, has planned use of drugs or devices, or has been previously randomized in this trial. 12. Laboratory value abnormalities as defined by the protocol 13. Evidence of serious diabetic complications. 14. Patients who are Hepatitis B or C or HIV positive. 15. Patients who have undergone pancreatectomy or pancreas/islet cell transplant. 16. Patient with history or evidence of active severe proliferative retinopathy, nephropathy and/or neuropathy significant cardiovascular disease, anemia or hemoglobinopathy, endocrinology, renal, hepatic, pulmonary, gastrointestinal, musculoskeletal, peripheral vascular, psychiatric, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1C Timepoint: Change in HbA1c at baseline(screening)and day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage reduction of Fasting Blood Glucose (FBG) levels Percentage reduction of Postprandial Blood Glucose (PPBG) levels Continuous Glucose Measurements The adverse effects of the study drugTimepoint: FBG & PBG levels at baseline Visit 1 (Day -14 to -1) Visit 3 (Day 21±3)Visit 4 (Day 63±3) and at Visit 5 (Day 84±3) Continuous Glucose Measurements in 25 patients in each treatment arm at baseline and end of the study The adverse effects of the study drug will be assessed by monitoring adverse events vital signs physical examination and clinically significant changes in laboratory parameters | — |
Countries
India
Contacts
Public ContactDr Someswara Rao Korla
someswararao.korla@jeevanscientific.com
Outcome results
None listed