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NCT00604253 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00604253
Other study ID # NN304-1477
Secondary ID JapicCTI-R070009
Status Completed
Phase Phase 3
First received January 17, 2008
Last updated January 26, 2017
Start date December 2003
Est. completion date May 2005

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 362
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin detemir

• insulin NPH

Locations
Country Name City State
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (2)

Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 36-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Once Daily Treatment as an Add-on Current Oral Hypoglycemic Agen

Tajima N, Iwamoto Y, Kaku K, Kawamori R, Nishida T, Kobayashi M. Once-daily insulin detemir added to oral antidiabetic drugs results in less weight gain and a trend for reduced hypoglycaemia in comparison with NPH insulin in Japanese patients with type 2

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 36 weeks of treatment
Secondary Plasma glucose profiles
Secondary Incidence of hypoglycaemic episodes
Secondary Adverse events
Secondary Insulin antibodies
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