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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1

• Registration Number: NCT00184639
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-16
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2005-11-22
• Study Completion: 2005-11-22
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 %

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Exclusion Criteria

• Current treatment with premixed insulin(s)
• Impaired hepatic or renal function
• Recurrent major hypoglycaemia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Fasting plasma glucose	after 16 and 32 weeks, respectively

Secondary Outcome Measures

Name	Time	Method
Adverse events
HbA1c results at the end of each treatment period
Blood glucose
Standard Laboratory Safety Parameters
Hypoglycaemia

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Hannover, Germany