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Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes
Plain-language guide to NCT01006291: phase 3 randomized trial of Insulin Glargine, 687 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01006291
- Phase
- phase 3
- Status
- completed
- Start
- 2009-11
- Completion (planned or actual)
- 2010-09
- Participants
- 687 (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
The trial (phase 3) is built around Insulin Glargine.
This trial is conducted in Africa, Asia, Europe and South America.
The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes.
It had three arms (groups): IDeg OD FF (experimental), IDeg OD (experimental) and IGlar OD (experimental).
The registry classes the interventions as drug.
Who Took Part
687 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 mellitus (diagnosed clinically) for at least 6 months. Body Mass Index (BMI) below or equal to 40.0 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.
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 2009-11 with completion listed for 2010-09.
It ran at 72 sites in India (11), Israel (8), United Kingdom (8), Finland (7), Russia (7) and Norway (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 3 secondary outcomes, for example Mean of 9-point Self Measured Plasma Glucose Profile (SMPG), Rate of Confirmed Hypoglycaemic Episodes and Rate of Nocturnal Confirmed Hypoglycaemic Episodes.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 687 people.
With 687 participants it is a large trial for this field.
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.