A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin

What Was Tested

The trial (phase 3) is built around Insulin Detemir and NPH Insulin (isophane).

This trial is conducted globally.

It had two arms (groups): Insulin detemir and diet/exercise (experimental) and Insulin NPH and diet/exercise (active comparator).

Current OADs i.e. metformin or other OADs are continued unchanged.

Current OADs i.e. metformin or other OADs are continued unchanged.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 42 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

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

Examples of who could join: Male or female, above or equal to 10 years and below or equal to 17 years at the time of signing informed consent/assent. Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: maturity onset diabetes of the young (mody); fasting c-peptide at screening below 0.6 ng/ml; impaired liver function defined as alanine aminotransferase (alt) above or equal to 2.5 times upper normal limit.

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.

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

It started in 2014-06-11 with completion listed for 2016-06-14.

It ran at 82 sites in United States (23), India (8), Turkey (Türkiye) (5), Brazil (4), Malaysia (4) and Morocco (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (Glycosylated Haemoglobin) (time frame: week 0, week 26).

It also tracked 6 secondary outcomes, for example Change in Body Weight Standard Deviation Score (SDS), Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes, Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Incidence of Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 42 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.