← Human Trials & Peer-Reviewed Studies
Safety of Insulin Detemir in Children With Type 1 Diabetes
Plain-language guide to NCT00605137: phase 3 randomized trial of Insulin Detemir and NPH Insulin (isophane), 83 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00605137
- Phase
- phase 3
- Status
- completed
- Start
- 2004-05-21
- Completion (planned or actual)
- 2005-04-23
- Participants
- 83 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin Detemir and NPH Insulin (isophane).
This trial is conducted in Japan.
The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children with type 1 diabetes.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 83 actual participants took part.
It was open to people of any sex aged from 7 years up to 18 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes for at least one year. Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin. Willing to comply with Investigator's instructions. Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia.
The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: impaired renal function; impaired hepatic function; known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the investigator or sub-investigator).
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Insulin Detemir study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Insulin Detemir group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin Detemir study did not mask who received what.
It started in 2004-05-21 with completion listed for 2005-04-23.
It ran at 1 site in Japan.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Incidence of hypoglycaemic episodes (time frame: during treatment).
It also tracked 5 secondary outcomes, for example Adverse events, Laboratory assessments and other safety endpoints, HbA1C, self monitored blood glucose and within-subject variability of glucose and Height.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 83 people.
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.