Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes

A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus on a Basal-bolus Regimen

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00604344

Enrollment

401

Registered

2008-01-30

Start date

2003-04-30

Completion date

2005-03-31

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

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 subjects with insulin requiring diabetes.

Interventions

DRUGinsulin detemir

DRUGinsulin NPH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Duration of diabetes mellitus for at least 2 years * Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart * HbA1C below 11.0%

Exclusion criteria

* Impaired renal function * Impaired hepatic function * Serious heart diseases * Known hypoglycaemia unawareness or recurrent major hypoglycaemia * Proliferative retinopathy or maculopathy requiring acute treatment * Uncontrolled treated/untreated hypertension * Current treatment with total insulin dose of more than 100 IU/day * Current treatment or expected at the screening to start treatment with systemic corticosteroids

Design outcomes

Primary

Measure	Time frame
HbA1c	after 48 weeks of treatment

Secondary

Measure	Time frame
Blood glucose profiles	—
Hypoglycaemic episodes	—
Adverse events	—
Body weight	—
Insulin antibodies	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026