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Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes
Plain-language guide to NCT01272193: phase 3 randomized trial of Insulin Glargine and Insulin Aspart, 296 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01272193
- Phase
- phase 3
- Status
- completed
- Start
- 2011-01
- Completion (planned or actual)
- 2011-09
- Participants
- 296 (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 and Insulin Aspart.
This trial is conducted in Japan.
It had two arms (groups): IDegAsp OD (experimental) and IGlar OD (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 296 actual participants took part.
It was open to people of any sex aged from 20 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 35.0 kg/m\^2.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: use of glucagon-like peptide-1 (glp-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation.
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.
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 2011-01 with completion listed for 2011-09.
It ran at 50 sites in Japan (50).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 26).
It also tracked 5 secondary outcomes, for example Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal, Rate of Treatment Emergent Adverse Events (AEs), Rate of Confirmed Hypoglycaemic Episodes, Rate of Nocturnal Confirmed Hypoglycaemic Episodes and Change in Body Weight.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 296 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 and the Insulin Aspart 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.
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.