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NCT00184639 Clinical Trial

Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes

Diabetes Clinical Trial

Official title:
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Semilente®MC in Children, Adolescents and Young Adults With Type 1 Diabetes on Basal-Bolus Regimen.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00184639
Other study ID # NN304-1630
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated February 22, 2017
Start date August 16, 2004
Est. completion date November 22, 2005

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

Clinical Trial Summary

This trial is conducted in Europe.

A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date November 22, 2005
Est. primary completion date November 22, 2005
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- Type 1 diabetes

- Current intensified insulin treatment

- Injection of insulin Semilente®MC at bedtime for at least 6 weeks

- BMI maximum 32 kg/m^2

- HbA1c > 5.5 % and < 12.0 %

Exclusion Criteria:

- Current treatment with premixed insulin(s)

- Impaired hepatic or renal function

- Recurrent major hypoglycaemia

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin detemir

Locations
Country Name City State
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Hannover

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

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fasting plasma glucose after 16 and 32 weeks, respectively
Secondary Adverse events
Secondary HbA1c results at the end of each treatment period
Secondary Blood glucose
Secondary Standard Laboratory Safety Parameters
Secondary Hypoglycaemia
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