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Clinical Trials/NCT00117780
NCT00117780
Completed
Phase 4

Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes

Novo Nordisk A/S1 site in 1 country520 target enrollmentJune 2005
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ConditionsDiabetesDiabetes Mellitus, Type 1
Drugsinsulin detemirinsulin aspart

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
520
Locations
1
Primary Endpoint
Mean HbA1c
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
October 2006
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Type 1 diabetes for more than 1 year
  • •Subject treated by any kind of insulin regimen and whatever the number of injections
  • •HbA1c = 7.5% and = 10%

Exclusion Criteria

  • •Type 2 diabetes
  • •Treatment by oral anti-diabetic drugs
  • •Severe medical conditions

Outcomes

Primary Outcomes

Mean HbA1c

Time Frame: after 4 months of insulin detemir treatment

Secondary Outcomes

  • HbA1c
  • Adverse events
  • Weight
  • Hypoglycaemia
  • Blood glucose
  • Insulin dose requirements during initial 4 months of treatment and during 3 months extension

Study Sites (1)

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