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NCT00312104 Clinical Trial

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

Diabetes Clinical Trial

Official title:
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00312104
Other study ID # NN304-1372
Secondary ID
Status Completed
Phase Phase 3
First received April 5, 2006
Last updated January 26, 2017
Start date April 2002
Est. completion date March 2003

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 325
Est. completion date March 2003
Est. primary completion date March 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin detemir

• insulin glargine

• insulin aspart

Locations
Country Name City State
Austria Novo Nordisk Investigational Site Graz
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Germany Novo Nordisk Investigational Site Bad Kreuznach
Germany Novo Nordisk Investigational Site Bad Mergentheim
Germany Novo Nordisk Investigational Site Bad Neuenahr-Ahrweiler
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Diez
Germany Novo Nordisk Investigational Site Erlangen
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Flensburg
Germany Novo Nordisk Investigational Site Frankfurt
Germany Novo Nordisk Investigational Site Friedrichsthal
Germany Novo Nordisk Investigational Site Genthin
Germany Novo Nordisk Investigational Site Halle
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Hannover
Germany Novo Nordisk Investigational Site Heidelberg
Germany Novo Nordisk Investigational Site Hennigsdorf
Germany Novo Nordisk Investigational Site Hünxe
Germany Novo Nordisk Investigational Site Jena
Germany Novo Nordisk Investigational Site Kiel
Germany Novo Nordisk Investigational Site Landau
Germany Novo Nordisk Investigational Site Ludwigshafen
Germany Novo Nordisk Investigational Site Marl
Germany Novo Nordisk Investigational Site Mönchengladbach
Germany Novo Nordisk Investigational Site Neunkirchen
Germany Novo Nordisk Investigational Site Neuss
Germany Novo Nordisk Investigational Site Northeim
Germany Novo Nordisk Investigational Site Nürnberg
Germany Novo Nordisk Investigational Site Rehlingen-Siersburg
Germany Novo Nordisk Investigational Site Rheda-Wiedenbrück
Germany Novo Nordisk Investigational Site Saarbrücken
Germany Novo Nordisk Investigational Site Saarlouis
Germany Novo Nordisk Investigational Site Schönebeck
Germany Novo Nordisk Investigational Site Schwabenheim
Germany Novo Nordisk Investigational Site Schwerin
Germany Novo Nordisk Investigational Site Völklingen
Germany Novo Nordisk Investigational Site Wiesbaden
Germany Novo Nordisk Investigational Site Würzburg
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Austria,  Germany,  South Africa, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 26 weeks of treatment
Secondary Adverse events
Secondary Body weight
Secondary Blood glucose
Secondary Hypoglycaemia
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