Liraglutide as add-on to Insulin in Type 1 Diabetes

What Was Tested

This registered phase 3 trial tested Liraglutide.

The purpose of this study is to: Part 1: To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.

Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.

It had four arms (groups): Placebo + Insulin + Study 2 (placebo comparator), Liraglutide + Insulin + Study 2 (experimental), Liraglutide + Insulin + Study 1 (experimental) and Placebo + Insulin + Study 1 (placebo comparator).

Study 2: Cognitive performance test.

Study 2: Cognitive performance test.

Study 1: Gastric emptying test.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age: 18-70 years. No residual β-cell function (glucagon test with c-peptide \< 60 pM). Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive). Remission phase must be completed. Female participants must use adequate contraception.

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: overt diabetes complications; creatinin \> 130 µm, proliferative retinopathy, macroalbuminuria; autonomic neuropathy (rr-variation \</=10 beats/min) and/or orthostatic hypotension (oh); pregnancy or lactation.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-03 with completion listed for 2014-10.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline in HbA1c (glycosylated haemoglobin) (time frame: Week 0, week 12). Changes from baseline in EEG and cognitive performances (time frame: week 0, week 12). Change from baseline in gastric emptying rate (time frame: week 0, week 12).

It also tracked 7 secondary outcomes, for example Change from baseline in glycemic control (CGM), Changes from baseline in the counterregulatory hormone responses during hypoglycemia, Change from baseline in body weight, Change from baseline in auditory evoked potentials (AEP) during hypoglycemia, Change from baseline in corrected QTc-interval (QTc) during hypoglycemia and Change from baseline in hypoglycemic symptom score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 40 people.

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

More context: the Liraglutide compound page, all human trials.