Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients

What Was Tested

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

It had two arms (groups): 1 (active comparator) and 2 (active comparator).

8 weeks of insulin Detemir, then cross over to 8 Weeks of Insulatard, then cross over to 1 week of Detemir.

8 weeks of Insulin Insulatard, then cross over to 8 weeks of insulin Detemir, then crossover to 1 week of Insulin Insulatard.

The registry classes the interventions as drug.

More on the Plan

Type 2 diabetic patients experience weight gain when receiving insulin treatment.

There has been reports that the weight gain is less or absent when patients are treated with Insulin Detemir.

Insulin Detemir i protein bound and is therefore not excreted in the kidneys.

The researchers test this hypothesis by examining urinary sodium excretion, extracellular volume by GFR measurements, Body composition by DEXA scan, body weight, and 24 hour blood pressure.In patients that are changed from Insulin Insulatard to Insulin Detemir and back.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Type 2 diabetes according to WHO 1999 criteria for at least 3 month. Insulin treated for at least 1 month.

How the Study Was Run

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

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.

In the crossover set-up each of the participants took both Insulin Detemir and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Insulin Detemir study: the participants and staff both knew the treatment.

It started in 2008-06 with completion listed for 2009-12.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: change in weight; change in extracellular volume (time frame: 17 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 24 people.

Its size is small, so on its own it can only give an early look.

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.