Trial Outcomes & Findings for The Effects of Metformin on Blood Vessel Structure and Function (NCT NCT00105066)
NCT ID: NCT00105066
Last Updated: 2017-01-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
Baseline and 4.5 months
Results posted on
2017-01-18
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo : placebo tablet once a day for one month, then twice a day for 3 months
|
Metformin
Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
50
|
|
Overall Study
COMPLETED
|
25
|
45
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo : placebo tablet once a day for one month, then twice a day for 3 months
|
Metformin
Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
Baseline Characteristics
The Effects of Metformin on Blood Vessel Structure and Function
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
Placebo : placebo tablet once a day for one month, then twice a day for 3 months
|
Metformin
n=49 Participants
Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 13.5 • n=99 Participants
|
55.1 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
54.4 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Gender
Female
|
19 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Gender
Male
|
8 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Carotid Femoral Pulse Wave Velocity
|
6.8 meters/second
STANDARD_DEVIATION 2.1 • n=99 Participants
|
6.8 meters/second
STANDARD_DEVIATION 2.1 • n=107 Participants
|
6.8 meters/second
STANDARD_DEVIATION 2.1 • n=206 Participants
|
|
FMD
|
7.6 percentage
STANDARD_DEVIATION 4.4 • n=99 Participants
|
9.3 percentage
STANDARD_DEVIATION 6.1 • n=107 Participants
|
8.5 percentage
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
HOMA-S
|
52.9 HOMA Score
STANDARD_DEVIATION 26.9 • n=99 Participants
|
52.3 HOMA Score
STANDARD_DEVIATION 23.1 • n=107 Participants
|
52.5 HOMA Score
STANDARD_DEVIATION 24.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4.5 monthsOutcome measures
| Measure |
Placebo
n=25 Participants
Placebo : placebo tablet once a day for one month, then twice a day for 3 months
|
Metformin
n=45 Participants
Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
|
|---|---|---|
|
Change in Arterial Stiffness Compared to Baseline
|
-7.2 meters / second
Standard Deviation 2.1
|
-7.3 meters / second
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Baseline and 4.5 monthsPopulation: Participants with complete data.
to evaluate improvement in endothelial function
Outcome measures
| Measure |
Placebo
n=23 Participants
Placebo : placebo tablet once a day for one month, then twice a day for 3 months
|
Metformin
n=39 Participants
Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
|
|---|---|---|
|
Change in Flow Mediated Dilation (FMD)
|
8.8 percentage change in diameter
Standard Deviation 7.0
|
10.5 percentage change in diameter
Standard Deviation 8.0
|
POST_HOC outcome
Timeframe: 4.5 monthsPopulation: Participants with complete data.
Homeostatic Model Assessment of insulin sensitivity
Outcome measures
| Measure |
Placebo
n=23 Participants
Placebo : placebo tablet once a day for one month, then twice a day for 3 months
|
Metformin
n=39 Participants
Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
|
|---|---|---|
|
Homa Insulin Sensitivity
|
57.4 HOMA Score
Standard Deviation 36.3
|
64.5 HOMA Score
Standard Deviation 27.7
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Metformin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Placebo : placebo tablet once a day for one month, then twice a day for 3 months
|
Metformin
n=50 participants at risk
Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Number of events 1
|
12.0%
6/50 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place