A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes

What Was Tested

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

The registry classes the interventions as drug.

More on the Plan

Todate, most studies have compared insulin detemir and glargine to NPH and not to each other.

The researchers have used continuous glucose monitoring (CGMS) extensively in their practice.

CGMS is arguably the most sensitive method for detecting differences in glycemic control in the outpatient setting and there by allowing fine adjustments in insulin treatment.

This allows for an even more accurate basal insulin replacement per set glycemic goal.

Who Took Part

The registry lists 35 planned participants were the target.

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: Currently on a basal insulin, that is, NPH, glargine or detemir. Capable of self monitoring glucose \>4/day. Previously complaint with clinical recommendations. Subject may be on oral antiglycemic medications but no change in treatment is permitted during study.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: urinary ketosis; currently participating in another clinical trial; known or suspected allergy to insulin glargine or detemir.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

It started in 2006-10 with completion listed for 2007-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): In the time period 2400 to 0600 hours (the Basal Period) when post-meal food is least likely to affect the glucose level, detect the mean percentage pf time the glucose level is between [amount hidden]/dL.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine and Insulin Detemir in 35 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 Glargine compound page and the Insulin Detemir compound page, all human trials.