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Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)
Plain-language guide to NCT01212913: phase 4 randomized trial of Insulin Glargine and Insulin Aspart, 161 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01212913
- Phase
- phase 4
- Status
- completed
- Start
- 2010-08
- Completion (planned or actual)
- 2012-05
- Participants
- 161 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine and Insulin Aspart.
It had two arms (groups): group 1: Basal plus (experimental) and group 2: Biphasic insulin (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 161 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: Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months:. Male or Female ≥18 years old. Body Mass Index (BMI) \<40. Patients willing to sign data release consent form.
The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: diabetes other than t2dm; enrolled in other clinical trials; previous treatment with an insulin other than insulin glargine.
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 2010-08 with completion listed for 2012-05.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in hemoglobin A1c level (HbA1c) (time frame: At 6 months of treatment).
It also tracked 6 secondary outcomes, for example Rate of hypoglycemic events (total, severe, nocturnal), Change in body weight, Reactive Oxidative Stress (ROS) level changes, Change in Quality of Life and Continuous Glucose Monitoring System (CGMS) data.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 161 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.