Levemir-Body Composition and Energy Metabolism

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Insulin Detemir.

The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .

It had two arms (groups): 1:Insulin detemir (experimental) and 2:Insulin Glargin (active comparator).

Insulin detemir (Levemir® - Novolin® 4 pen).

Insulin glargine (Lantus® - Solostar®).

The registry classes the interventions as drug.

Who Took Part

42 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Type 2 diabetic patients who require basal (long-acting) insulin for the control of hyperglycemia according to the opinion of the investigator. Stable body weight for previous 3 months (± 5 kg). Structured exercise lower than 4 hours per week.

The full record lists 5 inclusion and 23 exclusion criteria; among the exclusions: type 1 diabetes mellitus; previous treatment with insulin (\< 6 months prior inclusion). insulin therapy for less than 6 days at the time of an acute event is acceptable; secondary diabetes mellitus (i.e. steroid induced, cushing syndrome, chronic pancreatitis, cystic fibrosis, etc.) and maturity-onset diabetes of the young.

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 Glargine and who got the comparison, which limits bias.

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

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

It started in 2009-03 with completion listed for 2014-04.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in total fat mass (in kg) (time frame: Baseline and 6 months).

It also tracked 1 secondary outcome, for example Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Detemir in 42 people.

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

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