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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00850161
• Other study ID #: Nasulin™-BNT-US-100-PK009
• Status: Withdrawn
• Phase: Phase 2
• First received: February 23, 2009
• Last updated: February 12, 2016
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2016
• Source: CPEX Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• aspart
Meal-time insulin. Administered subcutaneously based on routine clinical therapy.
• Nasulin™
100 IU(2 puffs in each nostril)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CPEX Pharmaceuticals Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is to determine whether intranasal administration of Nasulin™ will stimulate glucose disposal and suppress endogenous glucose production.		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	Yes