Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Detemir.

A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control despite intensive basal-bolus insulin regimen.

It had two arms (groups): PPE (experimental) and injections (active comparator).

PPE : CSII +/- Metformin.

INJ: basal/bolus MDI +/- Metformin.

The registry classes the interventions as drug.

More on the Plan

Visit 1: patient information and eligibility criteria assessment Visit 2: Inform consent signature and randomisation (group CSII or MDI).

Patients randomised in the CSII group are instructed to use pump between V2 and V3.

Start of CSII or MDI treatments.

Stop of all oral diabetic medications except for metformin, which is followed up until the end of the study.

Who Took Part

The registry lists 52 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: Type 2 diabetes mellitus. Age \> 18 years. Patients able to perform self-monitoring blood glucose (SMBG) measurement and insulin injections. SMBG \> 3/day.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: diabetic retinopathy contraindicating glycemic control intensification; situation or pathology not allowing therapeutic education program (blindness, deafness, low language fluency…); situation or pathology not allowing insulin therapy self-management and / or portable insulin pump use (rheumatologic pathology, low visual acuity, …).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

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

It started in 2009-03 with completion listed for 2013-02.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: 12 months).

It also tracked 2 secondary outcomes, for example self monitoring blood glucose measurements (frequency, mean and standard deviation, number of hypoglycaemic and hyperglycaemic events).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 52 people.

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

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