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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2 Delivery Systems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pump

Intervention Type DEVICE

insulin glargine

Intervention Type DRUG

insulin aspart

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No