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Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
Plain-language guide to NCT01497561: phase 1 randomized trial of Insulin Detemir and NPH Insulin (isophane), 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01497561
- Phase
- phase 1
- Status
- completed
- Start
- 2003-03
- Completion (planned or actual)
- 2003-06
- Participants
- 15 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Detemir and NPH Insulin (isophane).
This trial is conducted in Europe.
It had two arms (groups): insulin detemir (experimental) and insulin NPH (active comparator).
The registry classes the interventions as drug.
Who Took Part
15 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: Type 2 diabetes. Subjects treated with insulin for minimum 3 months. Duration of diabetes for at least 12 months. Body Mass Index (BMI) below 30 kg/m\^2.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: current treatment with insulin glargine; current treatment with drugs known to interfere with glucose metabolism; current treatment with oral antidiabetic drugs.
How the Study Was Run
The set-up was randomized, crossover and double-blind.
The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.
Each person switched between Insulin Detemir and the comparison at some point, usually with a gap in between.
Blinding on both sides kept the participants and researchers unaware of who received Insulin Detemir.
Those kept unaware of assignments: participant and investigator.
It started in 2003-03 with completion listed for 2003-06.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Area under the glucose infusion rate curve.
It also tracked 9 secondary outcomes, for example Maximum glucose infusion rate, Time to maximum glucose, Area under the curve, Maximum concentration, Time to maximum concentration and Insulin clearance.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 15 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compounds
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
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.