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

October 14, 2016 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Århus C, Denmark, 8000
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Variation in morning FPG Time Frame: Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge	Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)