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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00184613 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
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Scientific title:
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An Open-label, Randomised, In-patient, Cross Over PK/PD Trial Investigating the Pharmackinectic and Pharmacodynamic Profiles Following Continuous Subcutaneous Infusion of Insulin Aspart or Injection of Insulin Glargine in Subjects With Type 2 Diabetes Mellitus |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00184613 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Birgitte K. Berg, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk |
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Name:
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Peter Kruse, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with type 2 diabetes for more than 2 years
- Subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2
weeks
- Subjects currently treated with unchanged dose(s) for at least 1 month on one or two
Oral Anti-diabetic drugs
- BMI 25 - 40 kg/m2
- HbA1c < 9.5 %
Exclusion Criteria:
- Known or suspected allergy to trial product(s) or related products
- Previous randomisation in this trial
- Pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women
judged not to be using adequate contraceptive measures (Only sterilisation, intra
uterine devices and contraceptive pills are considered adequate contraceptive
methods)
- Mental incapacity, unwillingness or language barriers precluding adequate
understanding and co-operation.
- Any other significant illness such as endocrine, cardiac, neurological, malignant or
other pancreatic illness judged by Investigator
- Participation in other studies within the last three months
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Delivery Systems
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Diabetes
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Diabetes Mellitus, Type 2
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Intervention(s)
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Device: pump
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Drug: insulin aspart
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Drug: insulin glargine
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Primary Outcome(s)
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Variation in morning FPG
[Time Frame: Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge]
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Secondary Outcome(s)
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Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged
[Time Frame: No]
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Variation of pre-dinner plasma glucose collected in hospital on the last 3 days
[Time Frame: No]
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Secondary ID(s)
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2005-000268-22
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PDS253-1666
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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