Intranasal Insulin and Its Effect on Postprandial Metabolism in Comparison to Subcutaneous Insulin

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
CPEX Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00850161
First received: February 23, 2009
Last updated: July 12, 2010
Last verified: May 2009
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
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: September 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nasulin™
Intranasal insulin spray
Drug: Nasulin™
100 IU(2 puffs in each nostril)
Active Comparator: aspart
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
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: NCT00850161

Sponsors and Collaborators
CPEX Pharmaceuticals Inc.
Investigators
Principal Investigator: Adrian Vella, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Robert M. Stote, MD, CPEX Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00850161     History of Changes
Other Study ID Numbers: Nasulin™-BNT-US-100-PK009
Study First Received: February 23, 2009
Last Updated: July 12, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014