Trial Outcomes & Findings for Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) (NCT NCT00736385)
NCT ID: NCT00736385
Last Updated: 2024-01-26
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
24 months
Results posted on
2024-01-26
Participant Flow
11 subjects signed consent to participate. 2 subjects were screen failures. 9 subjects were randomized.
Participant milestones
| Measure |
Metformin
Metformin XR (extended-release) 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months
|
Placebo
Placebo capsule
Placebo: placebo 2000 mg daily for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Metformin
Metformin XR (extended-release) 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months
|
Placebo
Placebo capsule
Placebo: placebo 2000 mg daily for 12 months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
Baseline characteristics by cohort
| Measure |
Metformin
n=4 Participants
Metformin XR 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months
|
Placebo
n=5 Participants
Placebo capsule
Placebo: placebo 2000 mg daily for 12 months
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=39 Participants
|
5 participants
n=41 Participants
|
9 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Outcome measures
Outcome data not reported
Adverse Events
Metformin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metformin
n=4 participants at risk
Metformin XR 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months
|
Placebo
n=5 participants at risk
Placebo capsule
Placebo: placebo 2000 mg daily for 12 months
|
|---|---|---|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Bradycardia Syndrome
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Metformin
n=4 participants at risk
Metformin XR 2000 mg daily
Glucophage (Metformin): metformin XR 2000 mg daily for 12 months
|
Placebo
n=5 participants at risk
Placebo capsule
Placebo: placebo 2000 mg daily for 12 months
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck pain, low back pain
|
25.0%
1/4
|
20.0%
1/5
|
|
Musculoskeletal and connective tissue disorders
arthritis (shoulder and neck )
|
0.00%
0/4
|
20.0%
1/5
|
|
Infections and infestations
Sinus headache, sinus infection, cold
|
25.0%
1/4
|
40.0%
2/5
|
|
Skin and subcutaneous tissue disorders
Rash and itching or redness
|
0.00%
0/4
|
40.0%
2/5
|
|
Gastrointestinal disorders
Stomach cramping, diarrhea and vomitting
|
50.0%
2/4
|
0.00%
0/5
|
|
Eye disorders
bluriness of vision
|
0.00%
0/4
|
20.0%
1/5
|
|
Psychiatric disorders
Low energy and low mood
|
0.00%
0/4
|
20.0%
1/5
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/4
|
20.0%
1/5
|
|
Infections and infestations
Tooth pain
|
0.00%
0/4
|
20.0%
1/5
|
|
Renal and urinary disorders
gross bloody urine-renal stone
|
0.00%
0/4
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
25.0%
1/4
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
vitamin D deficiency
|
25.0%
1/4
|
0.00%
0/5
|
|
Surgical and medical procedures
Cut wound
|
25.0%
1/4
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place