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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01203774
First received: September 15, 2010
Last updated: February 1, 2017
Last verified: February 2017
  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 Phase
Diabetes Drug: Glargine insulin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
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:


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 ]

Secondary Outcome Measures:
  • Compliance and patient satisfaction [ Time Frame: 6 months of treatment after discharge from the hospital ]

Enrollment: 61
Study Start Date: September 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: February 1, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Colorado, Denver:
Diabetes

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017