Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Detemir.

It had three arms (groups): NPH insulin injection (experimental), detemir insulin injection (experimental) and glargine insulin injection (experimental).

NPH insulin will be injected in random order in one of three seperated visit days.

Insulin detemir will be injected in random order in one of three seperated visit days.

Insulin glargine will be injected in random order in one of three seperated visit days.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 19 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Diagnosis of diabetes mellitus according to WHO criteria; history and clinical course consistent with type 1 diabetes mellitus. Diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (CSII) at least 6 months at time of inclusion. Age ≥ 18 years. BMI between 18.5 and 28 kg /m2 (including both values).

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; recurrent major hypoglycaemic episodes; heart: unstable angina pectoris, ami \< 12 months or heart insufficiency classified according to nyha iii-iv.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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

It started in 2012-02 with completion listed for 2012-11.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): IGF-I(ng/ml) (time frame: 16 hours (from 18:00 to 10:00 next day)). IGFBP-1(ng/ml) (time frame: 16 hours (from 18:00 to 10:00 next day)). IGFBP-2(ng/ml) (time frame: 16 hours (from 18:00 to 10:00 next day)).

It also tracked 2 secondary outcomes, for example plasma glucose concentration (mmol/L) after a single injection of either NPH insulin, insulin Detemir or insulin glargine and insulin concentration (mmol/L) after a single injection of either NPH insulin, insulin Detemir or insulin glargine.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Detemir in 19 people.

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

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.