Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted in Europe.

The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.

It had two arms (groups): Insulin detemir (experimental) and Insulin NPH (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 86 actual participants took part.

It was open to people of any sex aged from 70 years with no upper age limit.

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

Examples of who could join: Type 2 diabetes. Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: secondary diabetes, mody (maturity onset diabetes of the young); previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the investigator); proliferative retinopathy, maculopathy requiring treatment,.

How the Study Was Run

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

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.

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

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

It started in 2007-07 with completion listed for 2008-12.

It ran at 2 sites in France (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Haemoglobin (HbA1c) at Month 7 (time frame: week 0, month 7).

It also tracked 12 secondary outcomes, for example Change in Glycosylated Haemoglobin (HbA1c) at Month 4, Change in Mean Fasting Plasma Glucose (FPG) at Month 7, Change in Mean Fasting Plasma Glucose (FPG) at Month 4, Change in Mean Pre-lunch Plasma Glucose at Month 7, Change in Mean Pre-lunch Plasma Glucose at Month 4 and Change in Mean Pre-dinner Plasma Glucose at Month 7.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 86 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.