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Intranasal Insulin and Its Effect on Postprandial Metabolism in Comparison to Subcutaneous Insulin
This study is not yet open for participant recruitment.
Verified by CPEX Pharmaceuticals Inc., May 2009
First Received: February 23, 2009   Last Updated: May 7, 2009   History of Changes
Sponsored by: CPEX Pharmaceuticals Inc.
Information provided by: CPEX Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00850161
  Purpose

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

Resource links provided by NLM:


Further study details as provided by CPEX Pharmaceuticals Inc.:

Primary Outcome Measures:
  • The primary endpoint is to determine whether intranasal administration of Nasulin™ will stimulate glucose disposal and suppress endogenous glucose production. [ Time Frame: Blood will be measured at -30, -20, -10, 0, 2, 6, 8, 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 minutes ] [ Designated as safety issue: Yes ]

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.

Detailed Description:

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:

  • Peak postprandial glucose disposal is higher and occurs earlier, in the presence of intranasal insulin administration than it is in more conventional forms of insulin dosing.
  • Peak suppression of endogenous glucose production is greater and occurs earlier, in the presence of intranasal insulin administration than it is in more conventional forms of insulin dosing.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Type 1 Diabetes
  • Age 18-50
  • Treatment management of MDI(multiple daily injections) or Insulin Pump
  • BMI between 19-30 Kg/M2
  • HbA1c less than or equal to 8.0%
  • 75 g OGTT (oral glucose tolerance test)study with insulin concentrations >80uU/mL

Exclusion Criteria:

  • Active Proliferative Retinopathy
  • Active Nephropathy
  • Chronic Upper Respiratory Conditions determined by MD
  • Pregnant or Lactating Female
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850161

Contacts
Contact: Robert Stote, MD 603-658-6100 rstote@cpexpharm.com

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
CPEX Pharmaceuticals Inc.
Investigators
Principal Investigator: Adrian Vella, MD Mayo Clinic
  More Information

No publications provided

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

Keywords provided by CPEX Pharmaceuticals Inc.:
Type 1 Diabetes
Nasal Insulin
Insulin Deficiency
Insulin-Dependent

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009