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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin detemir; Drug: insulin NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT00604344

JapicCTI-R070008 (Registry Identifier)

NN304-1476

Details and patient eligibility

About

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.

Enrollment: 401 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)