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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 23, 2009

Last Updated Date

May 7, 2009

Start Date ^†

July 2009

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00850161 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Basic Science, Open Label, Crossover Assignment, Bio-availability Study

Condition ^†

Type 1 Diabetes Mellitus

Intervention ^†

Drug: aspart
Drug: Nasulin™

Study Arms / Comparison Groups

Experimental: Intranasal insulin spray
Active Comparator: Subcutaneous administration

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

Estimated Completion Date

January 2010

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Robert Stote, MD

603-658-6100

rstote@cpexpharm.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00850161

Responsible Party

Robert M. Stote, MD, CPEX Pharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

CPEX Pharmaceuticals Inc.

Collaborators ^††

Investigators ^†

Principal Investigator:

Adrian Vella, MD

Mayo Clinic

Information Provided By

CPEX Pharmaceuticals Inc.

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.