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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00184613

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2 Delivery Systems	Device: pump Drug: insulin glargine Drug: insulin aspart	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2005

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Variation in morning FPG [Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge]

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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