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Basal-bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes (PININ Study)
Plain-language guide to NCT02333851: phase 4 randomized trial of Insulin Glargine, 72 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02333851
- Phase
- phase 4
- Status
- terminated early
- Start
- 2013-06
- Completion (planned or actual)
- 2014-02
- Participants
- 72 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin Glargine.
It had two arms (groups): Premixed insulin (experimental) and Basal-bolus (experimental).
Mixtard 30:70 Novonordisk® twice daily, before breakfast and before dinner.
'Lantus® once daily and Apidra® before meals.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 72 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.
The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: patients with hyperglycemia without a previous diagnosis of diabetes; patients with acute hyperglycemic emergencies or with severe hyperglycemia treated with intravenous insulin infusion on admission; patients treated with corticosteroids.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
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 2013-06 with completion listed for 2014-02.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Differences in mean daily blood glucose concentration (time frame: Participants will be followe for the duration of hospital stay, an expected average of 2 weeks).
It also tracked 3 secondary outcomes, for example Number and severity of hypoglycemia episodes and Measures of dispersion of glycemia values (Glycemia variability).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 72 people.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
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.