Back to resultsComparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2, Delivery Systems
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
pump
insulin glargine
insulin aspart
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Variation in morning FPG
Secondary Outcome Measures
Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged
Variation of pre-dinner plasma glucose collected in hospital on the last 3 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00184613
Brief Title
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The objective of the study is to investigate the effect and safety of continously basal delivered insulin aspart given by a pump versus once daily injection of insulin glargine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2, Delivery Systems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
pump
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Primary Outcome Measure Information:
Title
Variation in morning FPG
Time Frame
Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge
Secondary Outcome Measure Information:
Title
Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged
Title
Variation of pre-dinner plasma glucose collected in hospital on the last 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
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