Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Teneligliptin 20 mg alternate day therapy (Group B): Tablet Teneligliptin 20 mg oral once every alternate day for 3 months over and above standard of care.
Control Intervention1: Tenel
Sponsors
NONE
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with T2DM visiting Medicine / Endocrinology OPD/Ward who are taking metformin >=1000 mg for a duration of 3 months or more. 2) Age:18- 59 years. 3) HbA1c 7-9 %
Exclusion criteria
Exclusion criteria: 1) Type 1 Diabetes patients. 2) Patients taking metformin for less than 3 months duration. 3) Patients with known allergy to study drugs. 4) Pregnant and lactating women. 5)Patients with uncontrolled cardiovascular disorders. 6) Patients with severe life-threatening diseases. 7) Patients having renal dysfunction (serum creatinine 1.5 times more than the upper normal limit range). 8) Cases with hepatic dysfunction (SGOT and/ or SGPT levels 3-fold more than upper limit range). 9) Patients who have recent history of diabetic ketoacidosis. 10) Patients who are not willing / unable to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels from baseline to 3 months in both groups.Timepoint: 0,3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in incidence of adverse drug events among T2DM patients receiving daily versus alternate day teneligliptin 20 mg therapy.Timepoint: 0,3 months;Change in FBS levels from baseline to 3 months in both groups.Timepoint: 0,1,3 months | — |
Countries
India
Contacts
Public ContactDr Harmanjit Singh
Government medical college and hospital, Chandigarh
Outcome results
None listed