An observational, multicenter study to evaluate Evogliptin on glycemic control of HbA1c levels â?? A national wide cohort study on patients with type 2 diabetes mellitus in India. - EVOLVE

Alkem Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•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.

发起方

Alkem Laboratories Limited