Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes
1 other identifier
interventional
325
3 countries
46
Brief Summary
The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes
Started Apr 2002
Shorter than P25 for phase_3 diabetes
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 5, 2006
CompletedFirst Posted
Study publicly available on registry
April 7, 2006
CompletedJanuary 27, 2017
January 1, 2017
11 months
April 5, 2006
January 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
after 26 weeks of treatment
Secondary Outcomes (4)
Adverse events
Body weight
Blood glucose
Hypoglycaemia
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 diabetes for at least 12 months
- Current daily insulin dose of more than 1.4 IU/kg
- BMI lesser than or equal to 35 kg/m2
- HbA1c greater than 7.5% and less than or equal to 12.0%
- In Austria, age more than 19 years
You may not qualify if:
- Proliferate retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (46)
Novo Nordisk Investigational Site
Graz, 8036, Austria
Novo Nordisk Investigational Site
Vienna, 1030, Austria
Novo Nordisk Investigational Site
Vienna, 1090, Austria
Novo Nordisk Investigational Site
Vienna, A 1160, Austria
Novo Nordisk Investigational Site
Vienna, A-1130, Austria
Novo Nordisk Investigational Site
Bad Kreuznach, 55545, Germany
Novo Nordisk Investigational Site
Bad Mergentheim, 97980, Germany
Novo Nordisk Investigational Site
Bad Neuenahr-Ahrweiler, 53474, Germany
Novo Nordisk Investigational Site
Berlin, 10789, Germany
Novo Nordisk Investigational Site
Diez, 65582, Germany
Novo Nordisk Investigational Site
Erlangen, 91052, Germany
Novo Nordisk Investigational Site
Essen, 45138, Germany
Novo Nordisk Investigational Site
Flensburg, 24939, Germany
Novo Nordisk Investigational Site
Frankfurt, 60590, Germany
Novo Nordisk Investigational Site
Friedrichsthal, 66299, Germany
Novo Nordisk Investigational Site
Genthin, 39307, Germany
Novo Nordisk Investigational Site
Halle, 06120, Germany
Novo Nordisk Investigational Site
Hamburg, 20251, Germany
Novo Nordisk Investigational Site
Hanover, 30171, Germany
Novo Nordisk Investigational Site
Heidelberg, 69115, Germany
Novo Nordisk Investigational Site
Hennigsdorf, 16761, Germany
Novo Nordisk Investigational Site
Hünxe, 46569, Germany
Novo Nordisk Investigational Site
Jena, 07743, Germany
Novo Nordisk Investigational Site
Kiel, 24105, Germany
Novo Nordisk Investigational Site
Landau, 76829, Germany
Novo Nordisk Investigational Site
Ludwigshafen, 67059, Germany
Novo Nordisk Investigational Site
Marl, 45770, Germany
Novo Nordisk Investigational Site
Mönchengladbach, 41061, Germany
Novo Nordisk Investigational Site
Neunkirchen, 66538, Germany
Novo Nordisk Investigational Site
Neuss, 41460, Germany
Novo Nordisk Investigational Site
Northeim, 37154, Germany
Novo Nordisk Investigational Site
Nuremberg, 90402, Germany
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780, Germany
Novo Nordisk Investigational Site
Rheda-Wiedenbrück, 33378, Germany
Novo Nordisk Investigational Site
Saarbrücken, 66121, Germany
Novo Nordisk Investigational Site
Saarlouis, 66740, Germany
Novo Nordisk Investigational Site
Schönebeck, 39218, Germany
Novo Nordisk Investigational Site
Schwabenheim, 55270, Germany
Novo Nordisk Investigational Site
Schwerin, 19049, Germany
Novo Nordisk Investigational Site
Völklingen, 66333, Germany
Novo Nordisk Investigational Site
Wiesbaden, 65183, Germany
Novo Nordisk Investigational Site
Würzburg, 97072, Germany
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2193, South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4091, South Africa
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7130, South Africa
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7925, South Africa
Related Publications (1)
Pieber TR, Treichel HC, Hompesch B, Philotheou A, Mordhorst L, Gall MA, Robertson LI. Comparison of insulin detemir and insulin glargine in subjects with Type 1 diabetes using intensive insulin therapy. Diabet Med. 2007 Jun;24(6):635-42. doi: 10.1111/j.1464-5491.2007.02113.x. Epub 2007 Mar 22.
PMID: 17381500RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2006
First Posted
April 7, 2006
Study Start
April 1, 2002
Primary Completion
March 1, 2003
Study Completion
March 1, 2003
Last Updated
January 27, 2017
Record last verified: 2017-01