A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Liraglutide.

This trial is conducted in Africa, Asia, Europe, North America and South America.

The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.

It had two arms (groups): Insulin degludec/liraglutide QD + OAD(s) (experimental) and insulin glargine QD + OAD(s) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1012 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: Male or female, age greater than or equal to 18 years at the time of signing informed consent. Subjects diagnosed with type 2 diabetes mellitus. Body mass index greater than or equal to 20 kg/m\^2. Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: screening calcitonin greater than or equal to 50 ng/l; impaired liver function, defined as alat or asat greater than or equal to 2.5 times upper limit of normal; family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2016-01-31 with completion listed for 2018-10-03.

It ran at 143 sites in United States (44), India (13), South Africa (11), United Kingdom (9), Israel (8) and Norway (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification (time frame: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2).

It also tracked 53 secondary outcomes, for example Change in HbA1c, Change in Body Weight, Change in FPG, SMPG-9-point Profile (Individual Points in the Profile), Change in SMPG-mean 9-point Profile and Change in SMPG-mean Postprandial Increment Over All Meals.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Liraglutide in 1012 people.

With 1012 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 and the Liraglutide compound page, all human trials.