Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects 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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2003-06-30

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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insulin detemir

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)

insulin NPH

Group Type ACTIVE_COMPARATOR

insulin NPH

Intervention Type DRUG

Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)

Interventions

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insulin detemir

Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)

Intervention Type DRUG

insulin NPH

Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Subjects treated with insulin for minimum 3 months
* Duration of diabetes for at least 12 months
* Body Mass Index (BMI) below 30 kg/m\^2
* HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria

* Current treatment with insulin above 1.2 U/kg/day
* Current treatment with insulin glargine
* Current treatment with drugs known to interfere with glucose metabolism
* Current treatment with oral antidiabetic drugs

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No