- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00312104
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes
January 26, 2017 updated by: Novo Nordisk A/S
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
325
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria, 8036
- Novo Nordisk Investigational Site
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Wien, Austria, 1090
- Novo Nordisk Investigational Site
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Wien, Austria, 1030
- Novo Nordisk Investigational Site
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Wien, Austria, A 1160
- Novo Nordisk Investigational Site
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Wien, Austria, A-1130
- Novo Nordisk Investigational Site
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Bad Kreuznach, Germany, 55545
- Novo Nordisk Investigational Site
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Bad Mergentheim, Germany, 97980
- Novo Nordisk Investigational Site
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Bad Neuenahr-Ahrweiler, Germany, 53474
- Novo Nordisk Investigational Site
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Berlin, Germany, 10789
- Novo Nordisk Investigational Site
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Diez, Germany, 65582
- Novo Nordisk Investigational Site
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Erlangen, Germany, 91052
- Novo Nordisk Investigational Site
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Essen, Germany, 45138
- Novo Nordisk Investigational Site
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Flensburg, Germany, 24939
- Novo Nordisk Investigational Site
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Frankfurt, Germany, 60590
- Novo Nordisk Investigational Site
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Friedrichsthal, Germany, 66299
- Novo Nordisk Investigational Site
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Genthin, Germany, 39307
- Novo Nordisk Investigational Site
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Halle, Germany, 06120
- Novo Nordisk Investigational Site
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Hamburg, Germany, 20251
- Novo Nordisk Investigational Site
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Hannover, Germany, 30171
- Novo Nordisk Investigational Site
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Heidelberg, Germany, 69115
- Novo Nordisk Investigational Site
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Hennigsdorf, Germany, 16761
- Novo Nordisk Investigational Site
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Hünxe, Germany, 46569
- Novo Nordisk Investigational Site
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Jena, Germany, 07743
- Novo Nordisk Investigational Site
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Kiel, Germany, 24105
- Novo Nordisk Investigational Site
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Landau, Germany, 76829
- Novo Nordisk Investigational Site
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Ludwigshafen, Germany, 67059
- Novo Nordisk Investigational Site
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Marl, Germany, 45770
- Novo Nordisk Investigational Site
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Mönchengladbach, Germany, 41061
- Novo Nordisk Investigational Site
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Neunkirchen, Germany, 66538
- Novo Nordisk Investigational Site
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Neuss, Germany, 41460
- Novo Nordisk Investigational Site
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Northeim, Germany, 37154
- Novo Nordisk Investigational Site
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Nürnberg, Germany, 90402
- Novo Nordisk Investigational Site
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Rehlingen-Siersburg, Germany, 66780
- Novo Nordisk Investigational Site
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Rheda-Wiedenbrück, Germany, 33378
- Novo Nordisk Investigational Site
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Saarbrücken, Germany, 66121
- Novo Nordisk Investigational Site
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Saarlouis, Germany, 66740
- Novo Nordisk Investigational Site
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Schwabenheim, Germany, 55270
- Novo Nordisk Investigational Site
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Schwerin, Germany, 19049
- Novo Nordisk Investigational Site
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Schönebeck, Germany, 39218
- Novo Nordisk Investigational Site
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Völklingen, Germany, 66333
- Novo Nordisk Investigational Site
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Wiesbaden, Germany, 65183
- Novo Nordisk Investigational Site
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Würzburg, Germany, 97072
- Novo Nordisk Investigational Site
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Gauteng
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Johannesburg, Gauteng, South Africa, 2193
- Novo Nordisk Investigational Site
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KwaZulu-Natal
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Durban, KwaZulu-Natal, South Africa, 4091
- Novo Nordisk Investigational Site
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Western Cape
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Cape Town, Western Cape, South Africa, 7130
- Novo Nordisk Investigational Site
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Cape Town, Western Cape, South Africa, 7925
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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HbA1c
Time Frame: after 26 weeks of treatment
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after 26 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
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Adverse events
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Blood glucose
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Hypoglycaemia
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Body weight
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Primary Completion (Actual)
March 1, 2003
Study Completion (Actual)
March 1, 2003
Study Registration Dates
First Submitted
April 5, 2006
First Submitted That Met QC Criteria
April 5, 2006
First Posted (Estimate)
April 7, 2006
Study Record Updates
Last Update Posted (Estimate)
January 27, 2017
Last Update Submitted That Met QC Criteria
January 26, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN304-1372
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
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Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | Diabetes | Diabetes Mellitus, Type 1Germany
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Medical University of GrazCompleted
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Denmark
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Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesJapan
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
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Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, France, Austria, Norway, Algeria
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1United States, Germany