Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-08-31

Brief Summary

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In this study the investigators would like to test the hypothesis that in diabetic patients discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected Glargine in terms of diabetes control, compliance, and patient satisfaction and preference. The investigators will test this hypothesis in a randomized, crossover trial.

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Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pen-administered vs syringe-admnistered Glargine

SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin

Group Type ACTIVE_COMPARATOR

Glargine insulin

Intervention Type DRUG

20-180 units per day

Syringe-administered vs pen-administered Glargine

Syringe-administered Glargine insulin and then pen-administered Glargine insulin

Group Type ACTIVE_COMPARATOR

Glargine insulin

Intervention Type DRUG

20-180 units per day

Interventions

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Glargine insulin

20-180 units per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients with type 1 and 2 diabetes discharged from the hospital with recommendations to take Glargine

Exclusion Criteria

* Patients unwilling to participate and patients incapable of complying with the study regimen, such as patients with alcohol and drug addiction problems and patients with severe mental illness

Minimum Eligible Age

22 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No