Research on Human Insulin rDNA (Insuget) Safety and Efficacy in Patients With Type 2 Diabetes Mellitus

Detailed Summary

Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus. Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study. Sample size: The estimated target sample size is n=230. Study duration: 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy. * Primary (SAFETY Outcomes): * Frequency of adverse events during the course of study follow-up. * Frequency of serious adverse events. * SECONDARY OUTCOME MEASURES (EFFICACY ENDPOINTS) * Change from baseline in HbA1c% to the last-observation. * Change from baseline in fasting plasma glucose to the last- observation on treatment Ethical consideration: The ethical approval of study is taken from an independent ethics committee. The study will be conducted in compliance with the protocol, good clinical practices (GCP), the ethical principles that have their origin in the Declaration of Helsinki and the applicable regulatory requirements.

Study Details

Timeline

Interventions