The Effects of Insulin Detemir and Gliclazide-MR Treatments on Endothelial Functions in Patients With Type 2 Diabetes

What Was Tested

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

The main purpose of this study is to analyze the effects of the addition of sulfonylurea (gliclazide MR) or ,alternatively, basal insulin (insulin detemir) to life-style modification and metformin treatment as a second step treatment in type 2 diabetes mellitus on endothelial cell functions.

The second goal is to identify the effects of these treatment alternatives on body-mass index, the changes in body fat mass, insulin resistance and on the insulin secretion capacity of beta cells.

The third aim of this study is to determine the success rates of these treatment alternatives on glycemic control at 6 months follow-up.

It had two arms (groups): Gliclazide MR (active comparator) and Insulin Detemir (active comparator).

Early initiation of insulin detemir in contrast to Gliclazide MR treatment.

The registry classes the interventions as drug.

More on the Plan

The lack of enough number of randomized and controlled studies in the treatment of type 2 diabetes is the most important obstacle in recommending a single-drug or a combination treatment to the other.

The pleomorphic effects of the treatment choices other than the control of hyperglycemia in type 2 diabetes are equally important.

There is yet a lack of the comparison of different treatment alternatives found in the treatment algorithms of American Diabetes Association (ADA) both in terms of the effects on hyperglycemia control as well as other pleomorphic effects.

Some of these pleomorphic effects are the change in body-mass index, insulin resistance, insulin secretion capacity and the effects on endothelial functions and coagulation status.

Who Took Part

The registry lists 64 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

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

Examples of who could join: 7\<A1C ≤ 11. Patients without any previous use of oral antidiabetics other than metformin or insulin. Between 20 to 65 years old male or female patients.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: active hepatic disease; proliferative diabetic retinopathy; coronary artery disease.

How the Study Was Run

Design: 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.

The Insulin Detemir group and the comparison group ran side by side rather than switching.

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

It started in 2010-06 with completion listed for 2012-04.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The evaluation of the changes in Flow-Mediated Dilatation (FMD) at 12th and 24th weeks compared to the baseline level, as a Measure of Endothelial Function (time frame: The basal, 12th and 24th week after reaching the target glycemic levels). The Changes in the Peripheral Blood Levels of TNF-α, IL-6, MCP-1, sICAM-1, sVCAM-1, vWF, E-selectin, P-selectin, Endothelin-1, PAI-1, tPA and HMW Adiponectin at 12th and 24th weeks compared to the baseline level, as Measures of Inflam. and Coagulation (time frame: The basal, 12th and 24th week after reaching the target glycemic levels).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Detemir in 64 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.