Clinical trial NCT00850161: Intranasal Insulin and Its Effect on Postprandial Metabolism in Comparison to Subcutaneous Insulin
Official title: Intranasal Insulin and Its Effect on Postprandial Glucose Metabolism in Comparison to Subcutaneous Insulin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes
Nasal Insulin
Insulin Deficiency
Insulin-Dependent
Lead sponsor: CPEX Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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 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

Primary outcomes:
measure: The primary endpoint is to determine whether intranasal administration of Nasulin™ will stimulate glucose disposal and suppress endogenous glucose production.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, MD
role: PRINCIPAL_INVESTIGATOR
References: