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Trial Outcomes & Findings for The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes (NCT NCT00546728)

NCT ID: NCT00546728

Last Updated: 2013-11-08

Results Overview

Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

Change from baseline to 3 months

Results posted on

2013-11-08

Participant Flow

Patients were recruited from medical clinics

Participant milestones

Participant milestones
Measure
Exenatide
Three months of Exenatide. Exenatide was initiated at a dose of 5 mcg, twice a day for one month and up titrated to 10 mcg, twice a day for the remaining two months.
Metformin
Three months of Metformin. Metformin was initiated at a dose of 500 mg, twice a day for one month and up titrated to 1000 mg, twice a day for the remaining two months.
Overall Study
STARTED
25
25
Overall Study
COMPLETED
25
25
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Exenatide
n=25 Participants
Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
Metformin
n=25 Participants
Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
Total
n=50 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
25 Participants
n=5 Participants
25 Participants
n=7 Participants
50 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
58.7 years
STANDARD_DEVIATION 10 • n=5 Participants
58.4 years
STANDARD_DEVIATION 10.1 • n=7 Participants
58.5 years
STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
18 Participants
n=7 Participants
38 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
Region of Enrollment
United States
25 participants
n=5 Participants
25 participants
n=7 Participants
50 participants
n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 3 months

Population: All completers were included in the analysis

Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.

Outcome measures

Outcome measures
Measure
Exenatide
n=25 Participants
Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
Metformin
n=25 Participants
Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
Change in Reactive Hyperemic Index Over the 3-month Treatment Period
0.01 ratio
Standard Deviation 0.68
-0.17 ratio
Standard Deviation 0.72

Adverse Events

Exenatide

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Metformin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron S. Kelly, Ph.D.

University of Minnesota

Phone: 612-626-3492

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place