A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

This trial is conducted in the United States of America (USA).

It had two arms (groups): IDeg (experimental) and IGlar (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Type 1 diabetes. BMI (body mass index) below 35 kg/m\^2.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues; subjects with regular use of acetaminophen who are not willing to use another analgetic during cgm (continuous glucose monitoring) periods; stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

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.

It started in 2012-04 with completion listed for 2012-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Average Time Within Glycaemic Target Range (Above [amount hidden]/dL and Below [amount hidden]/dL).

It also tracked 5 secondary outcomes, for example Mean Interstitial Glucose (IG) Based on 14 Days of CGM, Fasting Plasma Glucose (FPG), Glycosylated Haemoglobin (HbA1c), Number of Treatment Emergent Adverse Events (AEs) and Number of Treatment Emergent Confirmed Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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