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Clinical Trials/NCT00184665
NCT00184665
Completed
Phase 3

2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.

Novo Nordisk A/S1 site in 1 country501 target enrollmentJune 2004
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ConditionsDiabetesDiabetes Mellitus, Type 1
Drugsinsulin detemirinsulin NPHinsulin aspart

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
501
Locations
1
Primary Endpoint
HbA1c
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin 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 insulin antibodies and side effects).

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
September 2006
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Type 1 diabetes
  • •Currently on basal-bolus regimen
  • •BMI = 35.0 kg/m2
  • •HbA1c =11.0%

Exclusion Criteria

  • •Proliferative retinopathy or maculopathy
  • •Recurrent major hypoglycaemia
  • •Cardial problems
  • •Uncontrolled hypertension
  • •Impaired hepatic or renal function

Outcomes

Primary Outcomes

HbA1c

Time Frame: after a two-year trial period

Secondary Outcomes

  • Hypoglycaemia
  • Body composition
  • Blood glucose
  • Body weight
  • Antibodies
  • Adverse events

Study Sites (1)

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