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

NCT05161741 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2023-02-06

No results posted yet for this study

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.

Conditions

  • Adverse Drug Event
  • Effect of Drug
  • Type 2 Diabetes Treated With Insulin

Interventions

DRUG

Insulin

Human rDNA Insulin (Insuget, local brand of Getz Pharma)

Sponsors & Collaborators

  • Getz Pharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161741 on ClinicalTrials.gov