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

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.

Sample size: The estimated target sample size is n=230.

It had 1 arm (groups): Uncontrolled diabetes requiring Insulin (experimental).

The registry classes the interventions as drug.

More on the Plan

METHODOLOGY: STUDY DESIGN: Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.

NUMBER OF SITES Total 04-05 sites.

STUDY DURATION 10-12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) SAMPLING TECHNIQUE A non-probability consecutive sampling method will be used to screen patients as per study eligibility criteria.

LABORATORY TESTING: Reputable laboratory is considered for testing of diabetes patients i.e.

Who Took Part

The registry lists 238 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients who give written informed consent. Type 2 diabetic males \& females with age 18 \& above years. Patients with uncontrolled Diabetes after intervention of lifestyle modifications plus oral and/or insulin therapy.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: known type 1 diabetes mellitus patients; presence of severe diabetes complications; history of renal and/or hepatic dysfunctions.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Insulin (regular human) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-01-01 with completion listed for 2022-11-30.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Frequency of adverse events, serious adverse events during the course of study follow-up (time frame: 6 months). Change from baseline in HbA1c% to the last-observation (time frame: 6 months). Change from baseline in fasting plasma glucose to the last- observation on treatment (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin (regular human) in 238 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.