Status:
COMPLETED
Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 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 the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in th...
Eligibility Criteria
Inclusion
- Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
- Specific inclusion criteria for subject with type 1 diabetes:
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
- Specific inclusion criteria for subject with type 2 diabetes:
- Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
- Treated with insulin for the past 3 months prior to screening
- Body Mass Index (BMI) between 22.0 and 35.0 kg/ m\^2 (both inclusive)
Exclusion
- Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
- Subject with a history of or presence of cancer
- Any condition that the Investigator and/or Sponsor feels would interfere with study
- Specific exclusion criteria for subject with type 2 diabetes:
- Therapy with oral antidiabetic drugs within the past 3 months prior to screening
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01865292
Start Date
August 1 2006
End Date
November 1 2006
Last Update
October 19 2015
Active Locations (1)
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1
Neuss, Germany, 41460