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

NCT00850161 | Withdrawn Phase 2

• 1 other identifier: Nasulin™-BNT-US-100-PK009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes; Nasal Insulin; Insulin Deficiency; Insulin-Dependent

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nasulin™

EXPERIMENTAL

Intranasal insulin spray

Drug: Nasulin™

aspart

ACTIVE COMPARATOR

Subcutaneous administration

Drug: aspart

Interventions

aspart DRUG

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

Also known as: insulin aspart

aspart

Nasulin™ DRUG

100 IU(2 puffs in each nostril)

Also known as: insulin

Nasulin™

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%
• g OGTT (oral glucose tolerance test)study with insulin concentrations \>80uU/mL

You may not qualify if:

• Active Proliferative Retinopathy
• Active Nephropathy
• Chronic Upper Respiratory Conditions determined by MD
• Pregnant or Lactating Female

Sponsors & Collaborators

• CPEX Pharmaceuticals Inc.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Adrian Vella, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 24, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2010
• Last Updated: February 15, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share