Liraglutide and Insulin Therapy in Patients With Type 2 Diabetes

What Was Tested

The trial (not phased) is built around Insulin (regular human) and Liraglutide.

Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes.

Weight gain is obviously undesirable in an already overweight population, but may also deter further optimization of insulin therapy.

It had two arms (groups): liraglutide (experimental) and insulin (active comparator).

The registry classes the interventions as drug.

More on the Plan

After 26 weeks, patients receiving standard care will subsequently be treated with liraglutide for 26 weeks.

The group on active liraglutide treatment will continue for an additional 26 weeks.

All subjects will continue insulin therapy and oral hypoglycaemic agents (SU derivatives and metformin allowed) treatment.

Thereafter, patients will perform blood glucose profiles prior to every outpatient visit.

Who Took Part

Enrollment: 50 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: Patients with type 2 diabetes mellitus on short-term insulin therapy (≤ 12 months); all types of insulin allowed. Documented insulin-associated weight gain ≥ 3.0 kg from the start of insulin therapy until inclusion. Age 18-75 years. BMI ≥ 25 kg/m2.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: inability to provide informed consent; type 1 diabetes mellitus, mody diabetes, or lada diabetes (presence of anti-gad); inflammatory bowel disease (e.g. m. crohn, ulcerative colitis).

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2012-02 with completion listed for 2014-05.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Body weight change (measured body weight at 26 weeks minus baseline body weight) (time frame: 26 weeks (26 weeks - baseline)).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Liraglutide in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Liraglutide compound page, all human trials.