Study on Liver Fat Content and Visceral Fat Mass in Overweight and Obese Type 2 Diabetes Patients After Treatment With Basal Insulin

What Was Tested

In this not phased trial, researchers set out to test Insulin Detemir.

Primary objective: To compare the change in liver fat content and visceral fat mass (cm2) assessed by MRS (Magnetic Resonance Spectroscopy) and MRI (Magnetic Resonance Image), after 26 weeks of treatment with insulin detemir once daily or insulin NPH once daily both with metformin in overweight and obese type 2 diabetic subjects.

Secondary objectives: To compare the two treatments with respect to: 1.

It had two arms (groups): neutral protamine insulin, metformin (active comparator) and insulin detemir, metformin (experimental).

NPH insulin once daily plus oral metformin twice or thrice daily during 26 weeks.

Insulin detemir once daily plus oral metformin twice or thrice daily during 26 weeks.

The registry classes the interventions as drug.

Who Took Part

50 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.). Female or male, 18 years≤age≤70years. Weight fluctuation\<2kg in one month prior to screening. Able and willing to perform self-monitoring of blood glucose. Willing to accept basal insulin therapy.

The full record lists 9 inclusion and 18 exclusion criteria; among the exclusions: participation in a clinical study of weight control within the last 3 months prior to screening; previous or planned surgical treatment of obesity; anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic steroids, non-selective beta-blockers or mono amine oxidase (mao) inhibitors.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Everyone knew when Insulin Detemir was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-01.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: The change in liver fat content and visceral fat mass (time frame: After 26 weeks of treatment).

It also tracked 9 secondary outcomes, for example MRI, Change in HbA1c, Change in Fasting plasma glucose, Weight at every visit, Waist and hip circumference at every visit and Hypoglycaemia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Detemir in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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