Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00312104
NCT00312104CompletedPhase 3

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.

Novo Nordisk A/S46 sites in 3 countries325 target enrollmentStarted: April 1, 2002Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
325
Locations
46
Primary Endpoint
HbA1c
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 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 1 diabetes for at least 12 months
  • •Current daily insulin dose of more than 1.4 IU/kg
  • •BMI lesser than or equal to 35 kg/m2
  • •HbA1c greater than 7.5% and less than or equal to 12.0%
  • •In Austria, age more than 19 years

Exclusion Criteria

  • •Proliferate retinopathy or maculopathy
  • •Recurrent major hypoglycaemia
  • •Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

Outcomes

Primary Outcomes

HbA1c

Time Frame: after 26 weeks of treatment

Secondary Outcomes

  • Blood glucose
  • Hypoglycaemia
  • Adverse events
  • Body weight

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (46)

Loading locations...

Similar Trials

Completed
Phase 3
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 DiabetesDiabetes Mellitus, Type 1Diabetes
NCT00312156Novo Nordisk A/S347
Completed
Phase 3
Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 DiabetesDiabetes Mellitus, Type 2Diabetes
NCT00605020Novo Nordisk A/S719
Completed
Phase 3
Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 DiabetesDiabetes Mellitus, Type 1Diabetes
NCT00435019Novo Nordisk A/S348
Completed
Phase 4
Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 DiabetesDiabetes Mellitus, Type 1Diabetes
NCT00117780Novo Nordisk A/S520
Completed
Phase 3
Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 DiabetesDiabetes Mellitus, Type 2Diabetes
NCT00283751Novo Nordisk A/S583