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

NCT ID: NCT00850161

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-09-30

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Nasulin™

Intranasal insulin spray

Group Type: EXPERIMENTAL

Nasulin™

Intervention Type: DRUG

100 IU(2 puffs in each nostril)

aspart

Subcutaneous administration

Group Type: ACTIVE_COMPARATOR

aspart

Intervention Type: DRUG

Meal-time insulin. Administered subcutaneously based on routine clinical therapy.

Interventions

aspart

Meal-time insulin. Administered subcutaneously based on routine clinical therapy.

Intervention Type: DRUG

Nasulin™

100 IU(2 puffs in each nostril)

Intervention Type: DRUG

Other Intervention Names

insulin aspart; insulin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CPEX Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Vella, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

Nasulin™-BNT-US-100-PK009

Identifier Type: -

Identifier Source: org_study_id