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Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Plain-language guide to NCT01059799: phase 3 randomized trial of Insulin Glargine, 435 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01059799
- Phase
- phase 3
- Status
- completed
- Start
- 2010-02-01
- Completion (planned or actual)
- 2010-12-16
- Participants
- 435 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Glargine.
This trial is conducted in Asia and Japan.
The aim of this trial is to compare insulin degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes never treated with insulin.
It had two arms (groups): IDeg OD (experimental) and IGlar OD (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 435 actual participants took part.
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: For Japan only: minimum age is 20 years. Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months. Body Mass Index (BMI) no higher than 35.0 kg/m\^2.
How the Study Was Run
The set-up was 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.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2010-02-01 with completion listed for 2010-12-16.
It ran at 53 sites in South Korea (19), Japan (12), Malaysia (8), Taiwan (7), Thailand (6) and Hong Kong (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 26).
It also tracked 3 secondary outcomes, for example Rate of Confirmed Hypoglycaemic Episodes, Rate of Nocturnal Confirmed Hypoglycaemic Episodes and Mean of 9-point Self Measured Plasma Glucose Profile (SMPG).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 435 people.
The trial is marked completed; 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.
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.