NCT00315952

Brief Summary

University of Pittsburgh Medical Center (UPMC) diabetes research physicians are studying the action in muscle tissue of "inhaled" insulin (Exubera®) and "infused" (intravenous or IV) insulin on blood sugar control in people with type 1 diabetes. Type 1 diabetics often take 2-4 shots of insulin every day. Exubera may offer an alternative to these insulin injections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 18, 2008

Status Verified

February 1, 2008

First QC Date

April 17, 2006

Last Update Submit

February 15, 2008

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitusinhaled insulinPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • To perform positron emission tomography (PET) imaging of [18F]-fluoro-deoxy-glucose (FDG) uptake by muscle, following administration of a single dose of inhaled compared to infused insulin in volunteers with type 1 diabetes

Secondary Outcomes (1)

  • To determine overnight rates of glucose production and plasma glucose after a single pre-dinner dose of inhaled compared to IV infused insulin in volunteers with type 1 diabetes

Interventions

ExuberaDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18 to 50 years old
  • Body mass index (BMI) 20 to 27 kg/m2 and a total body weight \> 50 kg (110 lbs)
  • Blood pressure: systolic \< 150; diastolic \< 95.
  • Type 1 DM
  • Have diagnosed diabetes type 1 for a minimum of 12 months prior to study entry
  • In good general health with no evidence or history of clinically significant hematological, renal, endocrine (other than diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
  • Hematocrit (Hct) \> 34%
  • ALT \< 60; AST \< 60
  • Alkaline phosphatase (Alk Phos) \< 150
  • Sensitive thyroid-stimulating hormone (sTSH) \< 6
  • Fasting (morning) glucose 100-160 mg/dl
  • Documented hemoglobin A1c (HbA1c) \< 7.5% at time of entry
  • Triglycerides \< 175
  • Cholesterol \< 275

You may not qualify if:

  • Exclude if unable to master use of the inhalation device after 3 attempts
  • Exclude if positive urine drug screen
  • Exclude if any episodes of severe hypoglycemia in the past 3 months
  • Exclude if pregnant or breastfeeding or unwilling to use an acceptable method of non-hormonal contraception from at least 14 days prior to the first dose of Exubera® until study is completed.
  • Exclude if any history of (h/o) asthma or chronic obstructive pulmonary disease (COPD)
  • Exclude if forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) \< 70% predicted
  • Exclude if treatment with an investigational drug within 30 days preceding the first dose of trial medication.
  • Exclude if blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing
  • Exclude if unable or unwilling to comply with the protocol as written
  • Exclude if any use of tobacco or nicotine containing products within the past 6 months
  • Exclude if history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months of screening
  • Exclude if claustrophobic, any surgical or vascular implants or pacemakers, or any metal in the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Exubera

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • David E. Kelley, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2006

First Posted

April 19, 2006

Study Start

April 1, 2006

Study Completion

December 1, 2006

Last Updated

February 18, 2008

Record last verified: 2008-02

Locations

US(1)