Comparison of Two Titration Programs of Adding Insulin Detemir to OADs in Poorly Controlled Type 2 Diabetes

What Was Tested

The trial (not phased) is built around Insulin Detemir.

It had two arms (groups): Active titration algorithm (active comparator) and Usual titration algorithm (experimental).

Contact with investigator only at routine study visit.

The registry classes the interventions as behavioral.

More on the Plan

This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the Taiwan.

The safety will be followed during the 24-week study period.

Inclusion criteria: Patients must meet all of the following criteria: 1.

Men and women with type 2 diabetes. 2. 20 years of age. 3.

Who Took Part

The registry lists 181 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Men and women with type 2 diabetes. 20 years of age. Patients who are willing and able to cooperate with study and give signed informed consent.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: patients with type 1 diabetes; renal dialysis patients; history of hypoglycemia unawareness.

How the Study Was Run

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

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.

Being open-label, the Insulin Detemir study did not mask who received what.

It started in 2011-01 with completion listed for 2015-10.

It ran at 3 sites in Taiwan (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To compare the change in HbA1c between two study groups at Week 24 (time frame: 24 weeks).

It also tracked 5 secondary outcomes, for example To compare the change in HbA1C between two study groups at Week 12, To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24, To compare the change in body weight at each visit and To evaluate the incidence of adverse events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Detemir in 181 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.