Ignite Creation Date:
2024-05-06 @ 12:07 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01499108
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2011-12-12
Brief Title:
Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes
Sponsor:
Peter Rossing
Organization:
Steno Diabetes Center Copenhagen
Study Overview
Official Title:
Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2013-07
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:
Liratime
Brief Summary:
Background Preclinical blood pressure BP data from studies of hypoglycemic effects of liraglutide treatment the LEAD program revealed a significant antihypertensive potential The time course and the mechanism behind this effect are unknown
Objectives To evaluate the time course of the antihypertensive effect of liraglutide treatment in patients with type 2 diabetes
Design Open-label study with intervention and subsequent washout period
Patient Population 35 hypertensive SBP 130 mm Hg and DBP 80 mmHg patients with type 2 diabetes
Intervention All patients will be treated with liraglutide 06 mg once daily for 7 days and will then be titrated to 12 mg once daily for 14 days and then titrated to 18 mg once daily for 4 weeks This is followed by a washout period of 3 weeks without liraglutide treatment
Endpoints 24-hour blood pressure natriuresis extra cellular volume ECV
Objectives To evaluate the time course of the antihypertensive effect of liraglutide treatment in patients with type 2 diabetes
Design Open-label study with intervention and subsequent washout period
Patient Population 35 hypertensive SBP 130 mm Hg and DBP 80 mmHg patients with type 2 diabetes
Intervention All patients will be treated with liraglutide 06 mg once daily for 7 days and will then be titrated to 12 mg once daily for 14 days and then titrated to 18 mg once daily for 4 weeks This is followed by a washout period of 3 weeks without liraglutide treatment
Endpoints 24-hour blood pressure natriuresis extra cellular volume ECV
Detailed Description:
Hypotheses Primary hypothesis Liraglutide treatment causes a reduction in 24h BP
Secondary hypothesis
The effect on BP may be mediated by an increase in natriuresis thereby affecting ECV
The effect on BP may be mediated by a decrease in arterial stiffness and central aortic pressure
Purpose Primary purpose
To assess how quickly the antihypertensive effect of liraglutide treatment set in after initiation in patients with type 2 diabetes
Secondary objectives
To measure the effect of liraglutide treatment on natriuresis
To measure the effect of liraglutide treatment on ECV
To measure the effect of liraglutide treatment on arterial stiffness
To measure weight change after initiation of liraglutide treatment
Secondary hypothesis
The effect on BP may be mediated by an increase in natriuresis thereby affecting ECV
The effect on BP may be mediated by a decrease in arterial stiffness and central aortic pressure
Purpose Primary purpose
To assess how quickly the antihypertensive effect of liraglutide treatment set in after initiation in patients with type 2 diabetes
Secondary objectives
To measure the effect of liraglutide treatment on natriuresis
To measure the effect of liraglutide treatment on ECV
To measure the effect of liraglutide treatment on arterial stiffness
To measure weight change after initiation of liraglutide treatment
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