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Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

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Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 1
Diabetes

Treatments

Drug: insulin NPH
Drug: insulin detemir
Drug: insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT00595374
NN304-1582

Details and patient eligibility

About

This trial is conducted in Europe.

The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

Enrollment

114 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Duration of type 1 diabetes for at least 12 months
  • BMI below 35 kg/m2
  • HbA1c between 7.0-12.0%
  • Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
  • Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

Exclusion criteria

  • Known or suspected allergy to trial product or related products
  • Previous participation in this trial
  • Receipt of any investigational products within the last 2 months prior to this trial
  • Drug or alcohol dependence
  • Pregnancy, breast-feeding or intention of becoming pregnant

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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