Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
CPEX Pharmaceuticals Inc. |
---|---|
Information provided by: | CPEX Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00850161 |
The purpose of this study is to determine if glucose peaks higher and earlier after a meal when a patient is given intranasal insulin instead of conventional insulin treatment.
Condition | Intervention | Phase |
---|---|---|
Type 1 Diabetes Mellitus |
Drug: aspart Drug: Nasulin™ |
Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Crossover Assignment, Bio-availability Study |
Official Title: | Intranasal Insulin and Its Effect on Postprandial Glucose Metabolism in Comparison to Subcutaneous Insulin |
Estimated Enrollment: | 16 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Nasulin™: Experimental
Intranasal insulin spray
|
Drug: Nasulin™
100 IU(2 puffs in each nostril)
|
aspart: Active Comparator
Subcutaneous administration
|
Drug: aspart
Administered subcutaneously based on routine clinical therapy.
|
Diabetes mellitus is a common metabolic disorder characterized by hyperglycemia which when untreated is associated with microvascular disease. Most people with type 1 diabetes are treated with a combination of long-acting (basal) insulin and short-acting (prandial) insulin administered prior to meals. This necessitates multiple daily injections (>3) which is a significant barrier to long-term compliance and treatment.
Intranasal administration of insulin has been developed in an effort to overcome the need for insulin injection prior to meals. The pharmacokinetic properties conferred to insulin by this route of administration suggest that postprandial glucose disposal may be stimulated leading to lower glucose concentrations in comparison to dosing via other routes. We propose to study postprandial glucose turnover in healthy volunteers with Type 1 diabetes to determine the effect of intranasal insulin on glucose disposal. We wish to do so in order to develop a greater understanding of how the different bioavailability timing of intranasal insulin might alter postprandial glucose disposal and suppression of endogenous glucose production. In order to address these questions we will address specific aims:
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert Stote, MD | 603-658-6100 | rstote@cpexpharm.com |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Adrian Vella, MD | Mayo Clinic |
Responsible Party: | CPEX Pharmaceuticals ( Robert M. Stote, MD ) |
Study ID Numbers: | Nasulin™-BNT-US-100-PK009 |
Study First Received: | February 23, 2009 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00850161 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Type 1 Diabetes Nasal Insulin Insulin Deficiency Insulin-Dependent |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 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 Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |