← Human Trials & Peer-Reviewed Studies
Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.
Plain-language guide to NCT01223131: phase 3 randomized trial of Insulin Glargine and NPH Insulin (isophane), 162 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01223131
- Phase
- phase 3
- Status
- completed
- Start
- 2011-02
- Completion (planned or actual)
- 2014-03
- Participants
- 162 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 1 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Glargine and NPH Insulin (isophane).
It had two arms (groups): Insulin glargine (experimental) and NPH insulin (active comparator).
Injection once daily at bedtime.
Injection once daily at bedtime or twice daily in the morning and at bedtime.
The registry classes the interventions as drug.
More on the Plan
The study duration for each patient is 28 weeks +/- 7 day broken down as follows: * Screening phase: up to 2 weeks * Run-in phase: 1 week * Treatment phase: 24 weeks * Follow-up: 1 week.
Who Took Part
162 actual participants took part.
It was open to people of any sex aged from 6 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 2 exclusion criteria; among the exclusions: treatment with oral or parenteral glucose-lowering medications other than insulin.
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.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2011-02 with completion listed for 2014-03.
It ran at 10 sites in China (10).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Absolute change of glycosylated hemoglobin (HbA1c) (time frame: from baseline to week 24).
It also tracked 7 secondary outcomes, for example Change in Fasting Blood Glucose (FBG), Change in nocturnal Blood Glucose (BG), Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG), Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia and Anti-glargine and anti-human insulin antibody assessment.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and NPH Insulin (isophane) in 162 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 and the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
Related Pages
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.