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Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
Plain-language guide to NCT01068678: phase 3 randomized trial of Insulin Glargine, 460 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01068678
- Phase
- phase 3
- Status
- completed
- Start
- 2010-02
- Completion (planned or actual)
- 2010-11
- Participants
- 460 (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 Africa, Asia, Europe, and North America.
It had two arms (groups): IDeg 3 times weekly (3TW) (experimental) and IGlar OD (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 460 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: Insulin naïve subject (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). Body Mass Index (BMI) 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.
Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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 2010-02 with completion listed for 2010-11.
It ran at 99 sites in United States (57), Canada (15), United Kingdom (9), Czechia (5), Israel (5) and Slovakia (5).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Glycosylated Haemoglobin (HbA1c) (time frame: 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 460 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.