DOMME Dose Optimization Multicentric Mexican Evaluation

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

To evaluate the efficiency of Lantus plus combined oral hypoglycaemic agents in terms of respondents percentage.

Describe the glycemia levels and body weight change in the two response groups, (respondents and non-respondents).

It had 1 arm (groups): 1 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 371 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: Patients with type 2 diabetes mellitus receiving antidiabetic treatment (1 or 2 oral agents) during more than 6 months, who need a prolonged action basal insulin to control hyperglycemia. Body mass index (BMI) \< 40 kg/m2. Voluntary acceptation of the treatment and capability to self inject the insulin glargine. Capability and desire to carry out self-determination of glycemia levels using glucometers.

The full record lists 5 inclusion and 21 exclusion criteria; among the exclusions: acute metabolic acidosis (\> 1 episode during the last year) or chronic, including diabetic ketoacidosis; clinical evidence of an active liver disease or serum alt/ast \>2.5 times the upper normality limit; A history of unnoticed hypoglycemia.

How the Study Was Run

Design: non-randomized, single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-04 with completion listed for 2008-12.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in the initial vs. final values of HbA1c (time frame: 9 months). Number of severe hypoglycemia (time frame: 9 months).

It also tracked 3 secondary outcomes, for example - Change in the fasting glucose values with each visit and - Change in body weight initial visit vs. final visit.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 371 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, all human trials.