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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01203774
First received: September 15, 2010
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
 Drug: Glargine insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients Discharged From the Hospital"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • HbA1c at three months of each period of treatment [ Time Frame: 3 months of each period of treatment after discharge from the hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance and patient satisfaction [ Time Frame: 6 months of treatment after discharge from the hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pen-administered vs syringe-admnistered Glargine
SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin
 Drug: Glargine insulin
20-180 units per day
Active Comparator: Syringe-administered vs pen-administered Glargine
Syringe-administered Glargine insulin and then pen-administered Glargine insulin
 Drug: Glargine insulin
20-180 units per day

  Eligibility

Ages Eligible for Study:   22 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203774

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Sanofi
Investigators
Principal Investigator: Boris Draznin, M.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01203774     History of Changes
Other Study ID Numbers: 10-0788
Study First Received: September 15, 2010
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013