Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013910
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-04-02
Brief Title:
NNC 90-1170 Mechanism of Action A Double-Blind Randomized Single-Center Placebo-Controlled Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
NNC 90-1170 Mechanism of Action A Double-Blind Randomized Single-Center Placebo-Controlled Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2001-11
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:
The purpose of this research study is to investigate the mechanism of action of a new investigational medication drug NNC 90-1170 which is being developed for the treatment of type 2 diabetes adult onset type of diabetes
NNC 90-1170 is a modified form of a hormone Glucagon-Like Peptide 1 or GLP-1 which is important for controlling insulin levels Insulin another hormone is also important for controlling blood glucose levels which are higher than normal in people who have type 2 diabetes This study will measure the effect of NNC 90-1170 active investigational drug to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes Also various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn
One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study and the effects of this dose will be compared to a placebo inactive substance that looks like the active drug This is a crossover study which means that subjects will be treated both with NNC 90-1170 and with placebo The order in which subjects will receive the treatments will be determined by chance randomly
The study will be conducted as a so-called double-blind study meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over
The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes and it will be conducted at 1 clinic the University of Michigan Health System in the United States
NNC 90-1170 is a modified form of a hormone Glucagon-Like Peptide 1 or GLP-1 which is important for controlling insulin levels Insulin another hormone is also important for controlling blood glucose levels which are higher than normal in people who have type 2 diabetes This study will measure the effect of NNC 90-1170 active investigational drug to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes Also various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn
One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study and the effects of this dose will be compared to a placebo inactive substance that looks like the active drug This is a crossover study which means that subjects will be treated both with NNC 90-1170 and with placebo The order in which subjects will receive the treatments will be determined by chance randomly
The study will be conducted as a so-called double-blind study meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over
The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes and it will be conducted at 1 clinic the University of Michigan Health System in the United States
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: