Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315952
Status:
COMPLETED
Last Update Posted:
2008-02-18
First Post:
2006-04-17
Brief Title:
Study to Estimate the Effects of Inhaled Versus Intravenous IV Infusion of Human Insulin in Subjects With Type 1 Diabetes
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Open-Label Randomized Two-Way Crossover Pilot Study to Estimate the Effects of Inhaled vs IV Infusion of Human Insulin With Regards to Glucose Disposal in Subjects With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
A dry powder insulin formulation delivered by an aerosol inhaler has been in clinical development for use in types 1 and 2 diabetes mellitus DM and just recently 1-27-06 received approval from the US Food and Drug Administration FDA for the clinical treatment of diabetes Administration of insulin without the need for subcutaneous SC injection is an attractive alternative for patients with diabetes There are preclinical and clinical data that indicate inhalation of insulin results in a more potent effect on glucose disposal and a lower fasting glucose than is attained with equivalent dosing of SC or intravenous IV insulin The physiological mechanisms are unclear but occur even when matched for pharmacokinetics
The current proposal seeks primarily to more fully delineate whether there are physiological differences in the metabolic effects of inhaled compared to IV infused insulin giving IV insulin to match the pharmacokinetics PK achieved with inhaled insulin
There are 3 specific aims
1 The first aim is to establish a protocol for matching the PK of inhaled insulin with the PK of intravenously infused insulin An infusion algorithm has been developed and will be tested and refined in healthy volunteers n 3-5 and will be used for the physiological studies aims outlined below
2 The second aim is to perform Positron Emission Tomography PET imaging of 18F-FDG uptake by muscle following administration of a single dose of inhaled compared to infused insulin Volunteers with type 1 DM n 12 will be studied serving as hisher within-subject control under each condition of insulin administration
In these type 1 diabetes mellitus type 1 DM volunteers we will test the hypothesis that a single dose of inhaled versus infused insulin matched for arterial concentrations causes greater stimulation of muscle glucose uptake
3 The third aim is to determine overnight rates of glucose production and plasma glucose after a single pre-dinner dose of inhaled compared to IV infused insulin The same 12 volunteers studied for Aim 2 will be studied the evening preceding the PET imaging studies and will serve as hisher within-subject control under each condition of insulin administration
The current proposal seeks primarily to more fully delineate whether there are physiological differences in the metabolic effects of inhaled compared to IV infused insulin giving IV insulin to match the pharmacokinetics PK achieved with inhaled insulin
There are 3 specific aims
1 The first aim is to establish a protocol for matching the PK of inhaled insulin with the PK of intravenously infused insulin An infusion algorithm has been developed and will be tested and refined in healthy volunteers n 3-5 and will be used for the physiological studies aims outlined below
2 The second aim is to perform Positron Emission Tomography PET imaging of 18F-FDG uptake by muscle following administration of a single dose of inhaled compared to infused insulin Volunteers with type 1 DM n 12 will be studied serving as hisher within-subject control under each condition of insulin administration
In these type 1 diabetes mellitus type 1 DM volunteers we will test the hypothesis that a single dose of inhaled versus infused insulin matched for arterial concentrations causes greater stimulation of muscle glucose uptake
3 The third aim is to determine overnight rates of glucose production and plasma glucose after a single pre-dinner dose of inhaled compared to IV infused insulin The same 12 volunteers studied for Aim 2 will be studied the evening preceding the PET imaging studies and will serve as hisher within-subject control under each condition of insulin administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None