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Cost Effectiveness of Glargine Insulin Versus NPH Insulin
Plain-language guide to NCT01832935: phase 4 randomized trial of Insulin Glargine and NPH Insulin (isophane), 200 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01832935
- Phase
- phase 4
- Status
- completed
- Start
- 2011-07
- Completion (planned or actual)
- 2012-07
- Participants
- 200 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine and NPH Insulin (isophane).
It had two arms (groups): insulin glargine (active comparator) and Insulin NPH (active comparator).
The registry classes the interventions as drug.
More on the Plan
This was a randomized double blind controlled clinical trial of 12months on subjects with type 2 diabetes.
Two hundred diabetic subjects, 18-65 years of age, were included in the study.
Any current and prior medications were acceptable for participant inclusion other than any type of insulin being evaluated.
Demographic and anthropometric variables were recorded.
Who Took Part
Enrollment: 200 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diabetes type 2. Age 18 to 65.
The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: alteration in insulin sensitivity such as major surgery, infection, renal failure (glomerular filtration rate \< 50),; glucocorticoid treatment,; recent (within 2 weeks) serious hypoglycemic episode (requires assistance of another),.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
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.
Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.
Those kept unaware of assignments: participant and care provider.
It started in 2011-07 with completion listed for 2012-07.
It ran at 1 site in Iran.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Number Of Hypoglycemic events (time frame: 3 months).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine and NPH Insulin (isophane) in 200 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 NPH Insulin (isophane) 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.
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
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.