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Sponsored by: |
Valeritas, LLC |
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Information provided by: | Valeritas, LLC |
ClinicalTrials.gov Identifier: | NCT00453934 |
The primary objective of this study is to compare patient preference of the h-Patch as delivery device for insulin lispro compared with either an insulin pen or needle and syringe in patients with diabetes, either Type 1 or Type 2, on stable multiple daily injection regimens. This will be assessed using an accepted preference scale.
Condition | Intervention | Phase |
---|---|---|
Type 1 Diabetes Type 2 Diabetes |
Device: h-Patch |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | h-Patch vs. Pen or Needle and Syringe as Insulin Administration Device in Type 1 or 2 Diabetes Patients Using MDI: Patient Preference and Glycemic Control After Switch in an Open-Label, Randomized Cross-Over Study |
Enrollment: | 11 |
Study Start Date: | May 2007 |
Study Completion Date: | September 2007 |
Patients with Type 1 Diabetes have an absolute deficiency in insulin production and benefit from physiologic insulin replacement, defined as administration of background and mealtime insulin. More than half of patients with Type 2 diabetes (T2DM) have less than 50% of their beta cell function at the time of diagnosis. Because of this, these patients would also benefit from the physiologic delivery of insulin. Currently, 4 or more injections per day are required to deliver the various different available insulins in a physiologic manner.
Valeritas has developed the h-Patch, a device suitable to make the delivery of basal and bolus insulin effective, simple and discrete. This study will measure patient preference, glucose control and safety of the h-Patch compared with patients' previous therapy. Patients previous therapy will be multiple daily injections delivered either by pens or needle and syringe.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pregnancy, breast-feeding, intention of becoming pregnant for female patients of child-bearing potential.
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United States, Texas | |
Diabetes and Glandular Research | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Mark S Kipnes, MD | Diabetes and Glandular Research |
Study ID Numbers: | V4001 |
Study First Received: | March 27, 2007 |
Last Updated: | December 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00453934 History of Changes |
Health Authority: | United States: Institutional Review Board |
Diabetes Type 1 Diabetes Type 2 Diabetes Physiologic Insulin Basal Insulin |
Bolus Insulin Mealtime insulin Insulin patch Multiple daily injections |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 Physiological Effects of Drugs |
Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |