Status:
COMPLETED
Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with...
Eligibility Criteria
Inclusion
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
- Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (SPC)
- HbA1c, 7.0-11.0 % (both inclusive)
- Body Mass Index (BMI), 25.0-37.0 kg/m\^2 (both inclusive)
Exclusion
- Metformin contraindication according to local practice
- Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1
- Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
- Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00613951
Start Date
January 1 2008
End Date
August 1 2008
Last Update
March 20 2017
Active Locations (31)
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1
Novo Nordisk Investigational Site
Helsinki, Finland, 00260
2
Novo Nordisk Investigational Site
Kuopio, Finland, 70210
3
Novo Nordisk Investigational Site
Lahti, Finland, 15110
4
Novo Nordisk Investigational Site
Pori, Finland, FI-28100