A clinical trial to study the effect of Evogliptin in patients with type 2 diabetes mellitus.
- Conditions
- Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
- Registration Number
- CTRI/2019/10/021542
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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:
Subjects presenting with any of the following will not be included in the trial:
1. Patients having screening HbA1c < 7%
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine change in HbA1c from baseline to week 12 in patients with type 2 diabetes.Timepoint: Week 12 & Week 24
- Secondary Outcome Measures
Name Time Method 1) To determine the change from baseline in Fasting Plasma Glucose <br/ ><br>2) To determine the change from baseline in Post-prandial Plasma Glucose <br/ ><br>3) To determine the changes from baseline in body weight. <br/ ><br>4) any serious or non-serious adverse event at the end of the treatment.Timepoint: Weeks 12 and 24.