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The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study
Plain-language guide to NCT01966978: phase 4 randomized trial of Insulin Aspart and Insulin Detemir, 157 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01966978
- Phase
- phase 4
- Status
- completed
- Start
- 2014-11
- Completion (planned or actual)
- 2017-12
- Participants
- 157 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2; Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Aspart and Insulin Detemir.
It had two arms (groups): Control: Metformin, Insulin Detemir, Insulin Aspart (active comparator) and Metformin, insulin determir, Liraglutide (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 157 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 17 exclusion criteria; among the exclusions: type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;; clinical state requiring inpatient admission/treatment;; contraindication or strong cautions to any of the study medications:.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Insulin Aspart 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.
Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2014-11 with completion listed for 2017-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean Change From Randomization in A1c at Week 26 (time frame: Baseline and Week 26).
It also tracked 7 secondary outcomes, for example Composite End-point, Percentage of Participants Reaching Pre-specified "Treatment Failure" Outcome, Mean Change From Randomization in Body Weight, Hypoglycemic Episodes, Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means and Change in Short Form-36 (SF-36) Questionnaire Score.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 157 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.
Our Notes on the Compounds
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
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.