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This study has been withdrawn prior to enrollment.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

February 23, 2009
July 12, 2010
July 2009
August 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00850161 on ClinicalTrials.gov Archive Site
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Intranasal Insulin and Its Effect on Postprandial Metabolism in Comparison to Subcutaneous Insulin
Intranasal Insulin and Its Effect on Postprandial Glucose Metabolism in Comparison to Subcutaneous Insulin

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.

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.
Interventional
Phase 2
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 1 Diabetes Mellitus
  • Drug: aspart
    Administered subcutaneously based on routine clinical therapy.
  • Drug: Nasulin™
    100 IU(2 puffs in each nostril)
  • Experimental: Nasulin™
    Intranasal insulin spray
    Intervention: Drug: Nasulin™
  • Active Comparator: aspart
    Subcutaneous administration
    Intervention: Drug: aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
16
September 2010
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00850161
Nasulin™-BNT-US-100-PK009
No
Robert M. Stote, MD, CPEX Pharmaceuticals
CPEX Pharmaceuticals Inc.
Not Provided
Principal Investigator: Adrian Vella, MD Mayo Clinic
CPEX Pharmaceuticals Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP