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

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Getz Pharma
• Treatments: Insulin

Criteria

Inclusion Criteria:

• Patients who give written informed consent.

• Type 2 diabetic males & females with age 18 & above years.

• HbA1c: 7.0% and above.

• Patients with uncontrolled Diabetes after intervention of lifestyle modifications plus oral and/or insulin therapy.

Exclusion Criteria:

• Known type 1 diabetes mellitus patients.

• History of severe hypoglycemia (<70mg/dL)

• History of hypersensitivity to any of the active or inactive ingredients of the insulin preparations used in the trial, and/or history of significant allergic drug reactions.

• Presence of severe diabetes complications.

• History of renal and/or hepatic dysfunctions.

• Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.

• History of acute coronary syndrome or stroke.

• Pregnant or lactating females.

• History of Acute psychiatric disorder or exacerbation of chronic psychiatric disorder.

• History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study