Insulin Glargine Versus Twice-Daily NPH

Plain-language guide to NCT00687453: phase 4 randomized trial of Insulin Glargine, 27 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00687453
Phase: phase 4
Status: terminated early
Start: 2003-02
Completion (planned or actual): 2009-08
Participants: 27 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes Mellitus
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

It had two arms (groups): Insulin glargine injected at bedtime (experimental) and NPH insulin injected twice-daily (active comparator).

Insulin glargine injected at bedtime.

NPH insulin injected twice-daily, before breakfast and at bedtime.

The registry classes the interventions as drug.

Who Took Part

The registry lists 27 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female, age 18-75. Type 2 diabetes diagnosed for at least 1 year. Body mass index (BMI) between 20 and 40 kg/m2.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: history of confirmed (or clinical suspicion of ) type 1 diabetes; female subjects of childbearing potential who are sexually active and not using a reliable form of contraception; current pregnancy or lactation.

How the Study Was Run

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

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.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2003-02 with completion listed for 2009-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hemoglobin A1c Change From Baseline (time frame: Baseline to 6 months).

It also tracked 6 secondary outcomes, for example Frequency of Total Hypoglycemic Reactions, Frequency of Severe Hypoglycemic Reactions, Body Mass Index Change From Baseline and Any Adverse Event Other Than Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 27 people.

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

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

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

Our Notes on the Compound

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Insulin Glargine in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.