Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus

Novo Nordisk A/S1 site in 1 country114 target enrollmentDecember 2, 2003

ConditionsDiabetes Diabetes Mellitus, Type 1

Drugsinsulin detemir insulin NPH insulin aspart

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 114
Locations: 1
Primary Endpoint: HbA1c
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2, 2003

End Date

October 7, 2004

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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