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

NCT01203774 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 10-0788
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compliance and Patient Satisfaction

  6 months of treatment after discharge from the hospital

Study Arms (2)

Pen-administered vs syringe-admnistered Glargine

ACTIVE COMPARATOR

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

Drug: Glargine insulin

Syringe-administered vs pen-administered Glargine

ACTIVE COMPARATOR

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

Drug: Glargine insulin

Interventions

Glargine insulin DRUG

20-180 units per day

Pen-administered vs syringe-admnistered Glargine; Syringe-administered vs pen-administered Glargine

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Sanofi: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Limited results information is available. Multiple attempts were made to obtain this information, however the PI is retired and additional data could not be obtained from any remaining personnel associated with the study.

Results Point of Contact

• Title: Director, Clinical Research Administration
• Organization: University of Colorado Denver

clinicalresearchsupportcenter@ucdenver.edu

3037241111

Study Officials

• Boris Draznin, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 6, 2021
• Results First Posted: August 6, 2021

Record last verified: 2021-07

Locations

US (1)