A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-01-31

Brief Summary

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This trial is conducted in the United States of America (USA). This is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the final clinic visit. A subject's participation in this trial would be expected to be up to 16 weeks.

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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 aspart

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes diagnosis at least 2 years ago
* Body Mass Index (BMI): 26-40 kg/m\^2 (both inclusive)
* HbA1c: 7.5-10% (both inclusive)
* FPG values at least 140 mg/dl (7.8 mmol/l)

Exclusion Criteria

* Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action or glucose utilization (steroids or non-specific beta-blockers)
* Current addiction to alcohol or substances of abuse or positive results on urine screen for drug and alcohol use
* Known or suspected allergy to trial products or related products

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No