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Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
Plain-language guide to NCT01076647: phase 3 randomized trial of Insulin Glargine, 467 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01076647
- Phase
- phase 3
- Status
- completed
- Start
- 2010-03
- Completion (planned or actual)
- 2010-12
- Participants
- 467 (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
This registered phase 3 trial tested Insulin Glargine.
This trial was conducted in Europe and North America.
The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).
It had two arms (groups): IDeg 3TW (experimental) and IGlar OD (active comparator).
The registry classes the interventions as drug.
Who Took Part
467 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: Type 2 diabetes (diagnosed clinically) for at least 6 months. Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days). BMI (Body Mass Index) below or equal to 45.0 kg/m\^2.
How the Study Was Run
It was run as a randomized, parallel-group and open-label 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.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2010-03 with completion listed for 2010-12.
It ran at 105 sites in United States (66), France (8), Netherlands (8), Canada (7), Hungary (6) and Romania (6).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 26).
It also tracked 1 secondary outcome, for example Change in Body Weight.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 467 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.