Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Detemir.

One arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with APIDRA®.

It had two arms (groups): Intensified multiple injections (other) and Pumps (other).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 14 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: Persons who have provided written informed consent. Age \> 18 years. Patients with type 2 diabetes treated with insulin using a basal / bolus strategy for at least 6 months. Without OAD for at least 4 weeks (sulfamides, Incretines, glinides, acarbose) except Metformin. BMI ≥ 28.5 kg / m2.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: patients treated with glitazones during the 3 months preceding inclusion; patients with proliferative ischemic retinopathy not treated by laser; BMI \< 28.5 kg / m2.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Detemir study did not mask who received what.

It started in 2012-03-08 with completion listed for 2015-02-26.

It ran at 2 sites in France (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mixed measurement of insulin secretion and insulin resistance (time frame: Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 14 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Detemir compound page, all human trials.