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NCT Number: NCT01203774

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

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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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

22 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glargine insulin

Drug

20-180 units per day

Primary outcomes

  1. HbA1c at Three Months of Each Period of Treatment

    Time frame: Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)

    Data was collected by group

Secondary outcomes

  1. Compliance and Patient Satisfaction

    Time frame: 6 months of treatment after discharge from the hospital

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2010
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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