Status:
COMPLETED
Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting ins...
Eligibility Criteria
Inclusion
- Subjects with type 2 diabetes mellitus
- Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
- HbA1c below 10.0%
- Body Mass Index (BMI) \< 30.0 kg/m\^2
Exclusion
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- Current treatment with total insulin dose of more than 100 U or IU/day
- Current treatment or expected to start treatment with systemic corticosteroid
- Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer \[thiazolidinedione: TZD\]) within the last 12 weeks prior to screening
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00842361
Start Date
January 1 2009
End Date
June 1 2009
Last Update
February 9 2017
Active Locations (8)
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1
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0002
2
Novo Nordisk Investigational Site
Miyazaki, Japan, 880 0034
3
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, Japan, 311 0113
4
Novo Nordisk Investigational Site
Ota-ku, Tokyo, Japan, 144 0035