Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: pump (Device); insulin glargine (Drug); insulin aspart (Drug)

Phase: Phase 1

Status: Completed

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

Secondary outcome:

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. Gender(s): Both.

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

Aarhus, Denmark

Clinical Trials at Novo Nordisk

Starting date: May 2005
Last updated: September 10, 2007