Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: pump (Device); insulin glargine (Drug); insulin aspart (Drug)
Phase: Phase 1
Sponsored by: Novo Nordisk
Official(s) and/or principal investigator(s):
Peter Kruse, MD, PhD, Study Director, Affiliation: Novo Nordisk
Birgitte K. Berg, MSc, Study Director, Affiliation: Novo Nordisk A/S
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.
Official title: Investigating the Pharmacokinetic and Pharmacodynamic Profiles Following Continuous Subcutaneous Infusion of Insulin Aspart or Injection of Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
Study design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Variation in morning FPG
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
Minimum age: 18 Years.
Maximum age: 75 Years.
- Subjects with type 2 diabetes for more than 2 years
- Subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2
- 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 %
- 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
- 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
Locations and Contacts
Clinical Trials at Novo Nordisk
Starting date: May 2005
Last updated: September 10, 2007