Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230464
Status:
COMPLETED
Last Update Posted:
2006-01-04
First Post:
2005-09-28
Brief Title:
Acute Metabolic Effects of LAF 237 in Type 2 Diabetics
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Crossover Study to Explore the Acute Effects of LAF 237 on the Rate of Appearance and Disappearance of Glucose During the Overnight Post-Absorptive Period in Type 2 Diabetics
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Incretin hormones GIP and GLP-1 stimulate insulin release in a glucose dependant manner hence are necessary for maintenance of normal glucose tolerance Both GIP and GLP-1 are degraded and inactivated by DPP-4
LAF 237 is an inhibitor of DPP-4 that has been shown to increase meal-stimulated levels of intact GLP-1 in animals and patients with T2DM
The purpose of the current study is to explore the acute effects of LAF237 on the rate of appearance and disappearance of glucose in type 2 diabetics Secondary objectives include the effect on FPG insulin secretion rates glucagon and FFA levels and rate of glucose entry from the GI tract
LAF 237 is an inhibitor of DPP-4 that has been shown to increase meal-stimulated levels of intact GLP-1 in animals and patients with T2DM
The purpose of the current study is to explore the acute effects of LAF237 on the rate of appearance and disappearance of glucose in type 2 diabetics Secondary objectives include the effect on FPG insulin secretion rates glucagon and FFA levels and rate of glucose entry from the GI tract
Detailed Description:
Study Design Double blind placebo-controlled randomized two -period crossover study Sixteen 16 both sexes diabetic patients will be enrolled and randomized to receive one of two treatment sequences LAF-placebo or placebo-LAF
At screening patients will begin a weight maintaining diet containing 50 carbohydrates 30 protein and 20 fat
Within 7 days from screening patients will be scheduled for treatment 1 Patients will begin a 10-hour overnight fast on Day -1 at 21h00 Patients will be admitted to GCRC next day Fasting plasma glucose sample will be drawn and following this the patient will be served a standard breakfast containing 15 of their caloric allotment 50 carbohydrates 30 protein and 20 fat At noon patient will be fed a standard lunch containing 25 of their caloric allotment 50 carbohydrates 30 protein and 20 fat At 14h30 -210 an infusion of 3-3H glucose will be started and continued until 08h00 next day 20 µCi x FPG100 continuous 020min At 17h30 -30 patients will ingest 100 mg of LAF237 or placebo with 200 ml of water At 18h00 time zero patients will be served a dinner 25 of their caloric allotment The carbohydrates glucose in the meal will be labeled with 75 µCi of 1-14C-glucose
At -60 -50 -40 -35 -30 -20 -10 -5 and 0 minutes before dinner plasma samples for determination of glucose insulin C-peptide glucagons GLP-1 GIP FFA lactate and amino acid concentrations and 3-3H glucose radioactivity will be drawn Following dinner further blood samples will be drawn every 15 minutes for 35 hours 18h00-21h30 and every 30 minutes for the next 105 hours 22h00-08h00 Day 2 Post dinner samples will be analyzed for the above parameter as well as for 14C glucose radioactivity At 08h00 on Day 2 both catheters will be removed and the patients will be fed breakfast and then released from the site
In addition to blood samples urine from dinner time until 08h00 on Day 2 will be collected
At screening patients will begin a weight maintaining diet containing 50 carbohydrates 30 protein and 20 fat
Within 7 days from screening patients will be scheduled for treatment 1 Patients will begin a 10-hour overnight fast on Day -1 at 21h00 Patients will be admitted to GCRC next day Fasting plasma glucose sample will be drawn and following this the patient will be served a standard breakfast containing 15 of their caloric allotment 50 carbohydrates 30 protein and 20 fat At noon patient will be fed a standard lunch containing 25 of their caloric allotment 50 carbohydrates 30 protein and 20 fat At 14h30 -210 an infusion of 3-3H glucose will be started and continued until 08h00 next day 20 µCi x FPG100 continuous 020min At 17h30 -30 patients will ingest 100 mg of LAF237 or placebo with 200 ml of water At 18h00 time zero patients will be served a dinner 25 of their caloric allotment The carbohydrates glucose in the meal will be labeled with 75 µCi of 1-14C-glucose
At -60 -50 -40 -35 -30 -20 -10 -5 and 0 minutes before dinner plasma samples for determination of glucose insulin C-peptide glucagons GLP-1 GIP FFA lactate and amino acid concentrations and 3-3H glucose radioactivity will be drawn Following dinner further blood samples will be drawn every 15 minutes for 35 hours 18h00-21h30 and every 30 minutes for the next 105 hours 22h00-08h00 Day 2 Post dinner samples will be analyzed for the above parameter as well as for 14C glucose radioactivity At 08h00 on Day 2 both catheters will be removed and the patients will be fed breakfast and then released from the site
In addition to blood samples urine from dinner time until 08h00 on Day 2 will be collected
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