Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Male/ Female Patients above 18 years of age. 2. Patients with type 2 diabetes mellitus, receiving Evogliptin 5 mg tablet. 3. Patient willing to give written informed consent to participate in the study 4. In the judgment of the Principal Investigator, able to comply with protocol requirements.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial: 1. Patients having screening HbA1c 2. Patients having history of type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus. 3. Patients having history of pancreatitis/ pancreatic cancer 4. Patients with history of hypersensitivity to DPP-IV inhibitors/ Evogliptin 5. Concurrent or prior treatment with DPP-IV inhibitors within 8 weeks prior to the study. 6. Initiation of new antidiabetic therapy with-in 8 weeks prior to the study 7. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study. 8. Pregnant or lactating female. 9. Known history of drug or alcohol abuse within 3 months prior to the time of screening 10. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine change in HbA1c from baseline to week 12 in patients with type 2 diabetes.Timepoint: Week 12 & Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To determine the change from baseline in Fasting Plasma Glucose 2) To determine the change from baseline in Post-prandial Plasma Glucose 3) To determine the changes from baseline in body weight. 4) any serious or non-serious adverse event at the end of the treatment.Timepoint: Weeks 12 and 24. | — |
Countries
India
Contacts
Public ContactDr Prabhakar K
Alkem Laboratories Ltd
Outcome results
None listed