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Clinical Trials/NCT00604253
NCT00604253
Completed
Phase 3

Comparison of Efficacy and the Safety of Insulin Detemir and Insulin NPH as add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus

Novo Nordisk A/S1 site in 1 country362 target enrollmentDecember 2003
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ConditionsDiabetesDiabetes Mellitus, Type 2
Drugsinsulin detemirinsulin NPH

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
362
Locations
1
Primary Endpoint
HbA1c
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.

Registry
clinicaltrials.gov
Start Date
December 2003
End Date
May 2005
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Duration of type 2 diabetes mellitus for at least one year
  • •Insulin naive patients
  • •OHA treatment for at least 12 weeks
  • •HbA1C between 7.5-10.0%
  • •Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria

  • •Impaired renal function
  • •Impaired hepatic function
  • •Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods

Outcomes

Primary Outcomes

HbA1c

Time Frame: after 36 weeks of treatment

Secondary Outcomes

  • Insulin antibodies
  • Incidence of hypoglycaemic episodes
  • Plasma glucose profiles
  • Adverse events

Study Sites (1)

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