Status:
COMPLETED
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
MALE
18-69 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of i...
Eligibility Criteria
Inclusion
- The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
- ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
- ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:
- Diagnosed with type 2 diabetes mellitus for at least 12 months
- Treated with insulin for the last 3 months prior to screening.
- Body Mass Index (BMI) between 22.0 and 35.0 kg/m\^2 (both inclusive)
Exclusion
- A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
- A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01865305
Start Date
September 1 2006
End Date
February 1 2007
Last Update
October 23 2015
Active Locations (1)
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1
Neuss, Germany, 41460