Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

Primary Objective: -To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).

It had 1 arm (groups): HOE901 (experimental).

HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels.

The registry classes the interventions as drug.

More on the Plan

The total duration of study period per patient is up to 6 months.

Who Took Part

242 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: Patient ≥ 18 years old. Male or Female. Type 2 diabetes patients. Signed informed consent. Signed informed consent.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: patient not willing or not able to perform self-monitoring blood glucose; patient not willing or not able to self-titrate insulin glargine under physician's guidance; treatment with systemic corticosteroid within 3 months prior to study entry.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2015-11-22 with completion listed for 2017-11-27.

It ran at 1 site in Jordan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline in HbA1c (time frame: Baseline, 6 months).

It also tracked 8 secondary outcomes, for example - Change from baseline in fasting plasma glucose values, - Percentage of patients with hypoglycemic events, - Change from baseline in body weight, - Number of patients with adverse events and - Time to reach control.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine in 242 people.

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

More context: the Insulin Glargine compound page, all human trials.