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Clinical Trials/NCT00283751
NCT00283751CompletedPhase 3

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

Novo Nordisk A/S97 sites in 6 countries583 target enrollmentStarted: March 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
583
Locations
97
Primary Endpoint
HbA1c
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Type 2 Diabetes for more than 12 months, and no previous insulin treatment
  • •Oral Antidiabetic Drug treatment for at least 4 months
  • •Body Mass Index (BMI) less than 40 kg/m2
  • •HbA1c 7.5-10.0%

Exclusion Criteria

  • •Current or previous treatment with thiazolidinediones within the last 6 months
  • •Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
  • •Proliferative retinopathy or maculopathy
  • •Known hypoglycaemia unawareness

Outcomes

Primary Outcomes

HbA1c

Time Frame: after 52 weeks

Secondary Outcomes

  • Insulin antibodies
  • Plasma glucose profiles
  • Incident of hypoglycaemic episodes and adverse events
  • Change in body weight

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (97)

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