Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir; Drug: insulin NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT00604253

NN304-1477

JapicCTI-R070009 (Registry Identifier)

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 type 2 diabetes when added to current OHA treatment.

Enrollment: 362 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Duration of type 2 diabetes mellitus for at least one year
• Insulin naive patients
• OHA treatment for at least 12 weeks
• HbA1C between 7.5-10.0%
• Body Mass Index (BMI) below 30.0 kg/m2

Exclusion criteria

• Impaired renal function
• Impaired hepatic function
• Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)