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NCT01203774 Clinical Trial

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

Diabetes Clinical Trial

Official title:
"Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients Discharged From the Hospital"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01203774
Other study ID # 10-0788
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2010
Est. completion date August 2013

Study information
Verified date July 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender All
Age group 22 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Glargine insulin
20-180 units per day

Locations
Country Name City State
United States University of Colorado Denver Aurora Colorado

Sponsors (2)
Lead Sponsor Collaborator
University of Colorado, Denver Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c at Three Months of Each Period of Treatment Data was collected by group Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)
Secondary Compliance and Patient Satisfaction 6 months of treatment after discharge from the hospital
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