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Clinical Trials/NCT00184639
NCT00184639
Completed
Phase 3

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.

Novo Nordisk A/S1 site in 1 country71 target enrollmentAugust 16, 2004
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ConditionsDiabetesDiabetes Mellitus, Type 1

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
71
Locations
1
Primary Endpoint
Fasting plasma glucose
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 16, 2004
End Date
November 22, 2005
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fasting plasma glucose

Time Frame: after 16 and 32 weeks, respectively

Secondary Outcomes

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

Study Sites (1)

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