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

This study has been withdrawn prior to enrollment.
(Business purposes.)
Information provided by (Responsible Party):
CPEX Pharmaceuticals Inc. Identifier:
First received: February 23, 2009
Last updated: February 12, 2016
Last verified: February 2016
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: Allocation: Randomized
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 ]

Enrollment: 0
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)
Other Name: insulin
Active Comparator: aspart
Subcutaneous administration
Drug: aspart
Meal-time insulin. Administered subcutaneously based on routine clinical therapy.
Other Name: insulin aspart

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.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00850161

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

Responsible Party: CPEX Pharmaceuticals Inc. Identifier: NCT00850161     History of Changes
Other Study ID Numbers: Nasulin™-BNT-US-100-PK009 
Study First Received: February 23, 2009
Last Updated: February 12, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no data; study never initiated.

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

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 Aspart
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on October 21, 2016