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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604344
• Other study ID #: NN304-1476
• Secondary ID: JapicCTI-R070008
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2008
• Last updated: January 26, 2017
• Start date: April 2003
• Est. completion date: March 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• 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 subjects with insulin requiring diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

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 (3)

Ishii H, Iwamoto Y, Kaku K, Kawamori R, Tajima N, Kobayashi M. Quality of Life (QoL) Assessment of Insulin Detemir and NPH Human Insulin in Japanese Subjects with Diabetes on Basal-Bolus Regimen. Diabetes 2007; 56 (Suppl. 1): A170 (2805-PO)

Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 48-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Subjects with Insulin Requriring Diabetes Mellitus in a Basal-bo

Kobayashi M, Iwamoto Y, Kawamori R, Tajima N, Nishida T, Kaku K. Insulin detemir achieves lower, less variable fasting glucose and a reduced risk of nocturnal hypoglycaemia and weight gain compared to NPH insulin in basal bolus therapy of Japanese patient

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		after 48 weeks of treatment
Secondary	Blood glucose profiles
Secondary	Hypoglycaemic episodes
Secondary	Adverse events
Secondary	Body weight
Secondary	Insulin antibodies

External Links

•   Clinical Trials at Novo Nordisk