A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

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

Subjects are to continue their pre-trial metformin treatment.

It had two arms (groups): IDeg followed by IGlar (experimental) and IGlar followed by IDeg (experimental).

The registry classes the interventions as drug.

Who Took Part

145 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: Type 2 diabetes.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: current treatment with insulin other than insulin glargine in vials; treatment with thiazolidinediones or glucagon-like peptide-1 (glp-1) receptor agonists within 12 weeks; stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2012-04 with completion listed for 2014-01.

It ran at 46 sites in United States (45) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period (time frame: Week 0, week 16 of each treatment period).

It also tracked 5 secondary outcomes, for example Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period, Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B, Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period, Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B and Number of Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 145 people.

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.