A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs)

What Was Tested

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

This trial is conducted in Asia.

The aim of the trial is to compare the glycaemic control of Levemir® (insulin detemir) administered once daily according to two titration algorithms after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other anti-diabetic drugs (OADs).

It had two arms (groups): 3-0-3 Algorithm (experimental) and 2-4-6-8 Algorithm (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 46 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: \- Diagnosed with type 2 diabetes mellitus at least 3 months prior to Visit 1 (week -2). \- Insulin-naïve subjects. \- Body mass index (BMI) below or equal to 35.0 kg/m\^2.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: \- female who is breast-feeding; \- the receipt of any investigational product within 4 weeks prior to visit 1; \- any contraindication to insulin detemir according to the domestic labelling.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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 2013-06 with completion listed for 2015-05.

It ran at 6 sites in South Korea (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline (time frame: Week 0, week 20).

It also tracked 6 secondary outcomes, for example Change in HbA1c, Change in Fasting Plasma Glucose From Baseline, Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours, Change in Fasting Plasma Glucose From Baseline and Incidence of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 46 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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