Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

Most patients eventually require insulin which usually is added when glycemic control with a regimen of oral antidiabetic agents becomes suboptimal.

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

The registry classes the interventions as drug.

More on the Plan

Oral antihyperglycemic agents were continued at the prestudy dosages.

No dietary advice was given beyond reinforcement of standard guidelines.

Before the start of insulin therapy, and at weeks 12, 24 and 36, blood was withdrawn for measurements of full blood counts, electrolytes, creatinine, liver enzymes and lipids.

Who Took Part

The registry lists 100 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Men and women aged 30-70 years, with a duration of known diabetes \> 2 years. Body mass index less than 40 kg/m2.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: exclusion criteria included pregnancy or breast-feeding; previous use of insulin or other antihyperglycemic drugs; investigational drug within the previous 3 months.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

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

It started in 2007-01 with completion listed for 2007-12.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in hemoglobin A1c (HbA1c) level from baseline to end point for each treatment group (time frame: 9 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 100 people.

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, all human trials.