Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
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
2 other identifiers
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started May 2005
Typical duration for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedOctober 17, 2016
October 1, 2016
8 months
September 12, 2005
October 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Variation in morning FPG
Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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 %
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Århus C, 8000, Denmark
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
May 1, 2005
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
October 17, 2016
Record last verified: 2016-10