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

Comparison of Efficacy and the Safety of Insulin Detemir and Insulin NPH as add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00604253

Enrollment

362

Registered

2008-01-30

Start date

2003-12-31

Completion date

2005-05-31

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 2

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 type 2 diabetes when added to current OHA treatment.

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 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

Design outcomes

Primary

Measure	Time frame
HbA1c	after 36 weeks of treatment

Secondary

Measure	Time frame
Plasma glucose profiles	—
Incidence of hypoglycaemic episodes	—
Adverse events	—
Insulin antibodies	—

Countries

Japan

Outcome results

None listed

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