NCT00564018.
Methods |
Allocation: randomised Intervention model: parallel‐group assignment Masking: open‐label Primary purpose: treatment |
Participants |
Condition: T1DM Estimated number of participants: 33 Inclusion criteria: newly diagnosed T1DM within 1 week of diagnosis; age 6 to 18 years Exclusion criteria: actual treatment with oral drugs influencing beta cell function or blood glucose levels (e.g. oral hypoglycaemic agents); actual treatment with drugs influencing insulin sensitivity (e.g. metformin or systemic steroids); significant concomitant disease likely to interfere with glucose metabolism (children with active bacterial infections at the time of diagnosis must be cured prior to entry); expected poor compliance; pregnancy; any other condition that by the judgement of the investigator may be potentially harmful to the patients |
Interventions |
Intervention(s): detemir Comparator (1): glargine Comparator (2): NPH Duration of the intervention: planned to 1 year (but terminated early ‐ unknown when) |
Outcomes |
Primary outcome(s): C‐peptide Secondary outcome(s): HbA1c Other outcome(s): adverse events Relevant proposed outcome measures for SoF table: serious adverse events |
Reason for awaiting classification | Marked as terminated early ‐ the duration of the trial was not reported prior to termination |
Study details |
Study identifier: NCT00564018; UTSW‐052006‐056 Study start date: September 2006 Study completion date: April 2011 Responsible party/principal investigator: Soumya Adhikari, University of Texas Southwestern Medical Center, USA |
Official title and purpose of study | Quote: "To determine whether using a long‐acting insulin analog at the time of diagnosis, instead of intermediate‐acting insulin, affects the rate of loss of the body's ability to make insulin in children with newly diagnosed type 1 diabetes." |
Notes |