A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes

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).

It had two arms (groups): IDeg OD ± OADs followed by IGlar OD ± OADs (experimental) and IGlar OD ± OADs followed by IDeg OD ± OADs (active comparator).

The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.

The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 721 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.

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and double-blind.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-01-06 with completion listed for 2015-12-04.

It ran at 166 sites in United States (161) and Puerto Rico (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period (time frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)).

It also tracked 5 secondary outcomes, for example Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period, Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period, Incidence of Treatment Emergent Adverse Events, Change From Baseline in HbA1c (Glycosylated Haemoglobin) and FPG (Fasting Plasma Glucose).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 721 people.

With 721 participants it is a large trial for this field.

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.