Trial Outcomes & Findings for REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL) (NCT NCT01483560)
NCT ID: NCT01483560
Last Updated: 2019-06-19
Results Overview
Progression of averaged mean far wall common carotid artery intima media thickness IMT (mean cIMT) measured using B mode ultrasonography with a 7.0 MHz or higher broadband linear array transducer and concurrent recording of 3-lead electrocardiogram (ECG). Longitudinal images of the common carotid artery will be obtained at anterior, lateral and posterior angles at baseline, 12, 24 and 36 months using Meijer's arc to standardize the transducer angle.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
493 participants
Primary outcome timeframe
0, 12 months, 24 months, 36 months
Results posted on
2019-06-19
Participant Flow
493 participants where enrolled and consented. All participants entered a 3 month Run In phase with placebo. Participants who remained eligible were randomly assigned to receive metformin or placebo for 3 years. 65 participants where ineligible to be randomized.
Participant milestones
| Measure |
Metformin
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
219
|
209
|
|
Overall Study
COMPLETED
|
193
|
194
|
|
Overall Study
NOT COMPLETED
|
26
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Metformin
n=219 Participants
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=209 Participants
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=219 Participants
|
0 Participants
n=209 Participants
|
0 Participants
n=428 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
219 Participants
n=219 Participants
|
209 Participants
n=209 Participants
|
428 Participants
n=428 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=219 Participants
|
0 Participants
n=209 Participants
|
0 Participants
n=428 Participants
|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 8.5 • n=219 Participants
|
55.8 years
STANDARD_DEVIATION 8.8 • n=209 Participants
|
55.5 years
STANDARD_DEVIATION 8.7 • n=428 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=219 Participants
|
85 Participants
n=209 Participants
|
175 Participants
n=428 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=219 Participants
|
124 Participants
n=209 Participants
|
253 Participants
n=428 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
55 participants
n=219 Participants
|
55 participants
n=209 Participants
|
110 participants
n=428 Participants
|
|
Region of Enrollment
Netherlands
|
16 participants
n=219 Participants
|
15 participants
n=209 Participants
|
31 participants
n=428 Participants
|
|
Region of Enrollment
Denmark
|
4 participants
n=219 Participants
|
4 participants
n=209 Participants
|
8 participants
n=428 Participants
|
|
Region of Enrollment
United Kingdom
|
112 participants
n=219 Participants
|
105 participants
n=209 Participants
|
217 participants
n=428 Participants
|
|
Region of Enrollment
Australia
|
32 participants
n=219 Participants
|
30 participants
n=209 Participants
|
62 participants
n=428 Participants
|
|
Diabetes Diagnosis Duration
|
33.4 years
STANDARD_DEVIATION 11 • n=219 Participants
|
34.3 years
STANDARD_DEVIATION 10.5 • n=209 Participants
|
33.85 years
STANDARD_DEVIATION 10.75 • n=428 Participants
|
|
Existing Cardiovascular Disease
|
30 participants
n=219 Participants
|
22 participants
n=209 Participants
|
52 participants
n=428 Participants
|
|
Baseline HbA1c
|
64.8 mmol/mol
n=219 Participants
|
64.7 mmol/mol
n=209 Participants
|
64.75 mmol/mol
n=428 Participants
|
|
Daily Insulin Dose
|
0.63 units/kg
n=219 Participants
|
0.68 units/kg
n=209 Participants
|
0.66 units/kg
n=428 Participants
|
|
BMI
|
28.4 kg/m2
STANDARD_DEVIATION 4.5 • n=219 Participants
|
28.5 kg/m2
STANDARD_DEVIATION 4.1 • n=209 Participants
|
28.5 kg/m2
STANDARD_DEVIATION 4.3 • n=428 Participants
|
|
Blood Pressure
|
130.5 Systolic BP (mmHg)
STANDARD_DEVIATION 15 • n=219 Participants
|
128.5 Systolic BP (mmHg)
STANDARD_DEVIATION 14.6 • n=209 Participants
|
129.5 Systolic BP (mmHg)
STANDARD_DEVIATION 14.8 • n=428 Participants
|
|
Total Cholesterol
|
4 mmol/L
STANDARD_DEVIATION 0.88 • n=219 Participants
|
4 mmol/L
STANDARD_DEVIATION 0.93 • n=209 Participants
|
4 mmol/L
STANDARD_DEVIATION 0.91 • n=428 Participants
|
|
eGFR
|
92.9 ml/min/1.73m2
STANDARD_DEVIATION 20.9 • n=219 Participants
|
91.1 ml/min/1.73m2
STANDARD_DEVIATION 21.6 • n=209 Participants
|
92 ml/min/1.73m2
STANDARD_DEVIATION 21.3 • n=428 Participants
|
|
Diabetic Retinopathy
|
51 participants
n=219 Participants
|
58 participants
n=209 Participants
|
109 participants
n=428 Participants
|
PRIMARY outcome
Timeframe: 0, 12 months, 24 months, 36 monthsProgression of averaged mean far wall common carotid artery intima media thickness IMT (mean cIMT) measured using B mode ultrasonography with a 7.0 MHz or higher broadband linear array transducer and concurrent recording of 3-lead electrocardiogram (ECG). Longitudinal images of the common carotid artery will be obtained at anterior, lateral and posterior angles at baseline, 12, 24 and 36 months using Meijer's arc to standardize the transducer angle.
Outcome measures
| Measure |
Metformin
n=193 Participants
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=194 Participants
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT)
Baseline
|
0.773 mm
Standard Deviation 0.14
|
0.791 mm
Standard Deviation 0.183
|
|
Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT)
12 Months
|
0.782 mm
Standard Deviation 0.147
|
0.788 mm
Standard Deviation 0.174
|
|
Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT)
24 Months
|
0.792 mm
Standard Deviation 0.145
|
0.823 mm
Standard Deviation 0.187
|
|
Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT)
36 Months
|
0.793 mm
Standard Deviation 0.134
|
0.820 mm
Standard Deviation 0.177
|
SECONDARY outcome
Timeframe: Baseline, Year 3Measured in accredited local laboratories participating in DCCT-aligned quality control programmes.
Outcome measures
| Measure |
Metformin
n=193 Participants
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=194 Participants
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Change in HbA1c
Baseline
|
8.1 %units
Standard Deviation 0.9
|
8.0 %units
Standard Deviation 0.8
|
|
Change in HbA1c
36 Months
|
8.1 %units
Standard Deviation 0.9
|
8.1 %units
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline, Year 3mmol/L Centrally assayed at the University of Glasgow
Outcome measures
| Measure |
Metformin
n=193 Participants
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=194 Participants
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Change in LDL Cholesterol
Baseline
|
2.23 mmol/L
Standard Deviation 0.7
|
2.25 mmol/L
Standard Deviation 0.72
|
|
Change in LDL Cholesterol
36 Months
|
2.07 mmol/L
Standard Deviation 0.83
|
2.21 mmol/L
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline, Year 1, Year 2, Year 3Number of participants developing new microalbuminuria; change in absolute concentration Calculated using the MDRD equation1 based on creatinine measured in accredited local laboratories
Outcome measures
| Measure |
Metformin
n=193 Participants
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=194 Participants
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Change in Estimated Glomerular Filtration Rate
Baseline
|
92.9 ml/min/1.73m2
Standard Deviation 20.9
|
91.1 ml/min/1.73m2
Standard Deviation 21.6
|
|
Change in Estimated Glomerular Filtration Rate
36 Months
|
92.1 ml/min/1.73m2
Standard Deviation 20.8
|
87.2 ml/min/1.73m2
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Baseline, Year 3Two color 45° field retinal photographs (fields 1 and 2) from each eye at 0 and 36 months graded at the University of Wisconsin Ocular Epidemiology Reading Center (OERC) using the modified Airlie House classification scheme and the Early Treatment Diabetic Retinopathy Severity scale.
Outcome measures
| Measure |
Metformin
n=219 Participants
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=209 Participants
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Number of Participants With Retinopathy and at Least a 2 Stage Progression in Retinopathy From Baseline to 36 Months
Baseline
|
191 Participants
|
190 Participants
|
|
Number of Participants With Retinopathy and at Least a 2 Stage Progression in Retinopathy From Baseline to 36 Months
36 Months
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, Year 1, Year 2, Year 3Measured at sites using calibrated weighing scales
Outcome measures
| Measure |
Metformin
n=193 Participants
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=194 Participants
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Change in Weight
Baseline
|
83.9 kg
Standard Deviation 15.4
|
83.5 kg
Standard Deviation 13.7
|
|
Change in Weight
36 Months
|
82.0 kg
Standard Deviation 15.4
|
83.2 kg
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Baseline, Year 1, Year 2, Year 3Units/ kg body weight Extracted by study nurses from the Study Diary and reported on the study CRF using dedicated fields
Outcome measures
| Measure |
Metformin
n=193 Participants
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=194 Participants
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Change in Insulin Dose
Baseline
|
0.36 units/kg
Standard Deviation 0.26
|
0.68 units/kg
Standard Deviation 0.30
|
|
Change in Insulin Dose
36 Months
|
0.62 units/kg
Standard Deviation 0.26
|
0.67 units/kg
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline, Year 1, Year 3In some centres (Arbitrary units) Reactive Hyperaemia Index using the ENDOPAT device (Itamar, Israel)
Outcome measures
| Measure |
Metformin
n=193 Participants
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=194 Participants
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Change in Endothelial Function
Baseline
|
2.28 RHI (Arbitrary units)
Standard Deviation 0.74
|
2.24 RHI (Arbitrary units)
Standard Deviation 0.75
|
|
Change in Endothelial Function
36 Months
|
2.17 RHI (Arbitrary units)
Standard Deviation 0.69
|
2.24 RHI (Arbitrary units)
Standard Deviation 0.73
|
Adverse Events
Metformin
Serious events: 34 serious events
Other events: 112 other events
Deaths: 5 deaths
Placebo
Serious events: 31 serious events
Other events: 52 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Metformin
n=219 participants at risk
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=209 participants at risk
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Metabolism and nutrition disorders
Metabolic and nutrition
|
3.7%
8/219 • Number of events 8 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
2.4%
5/209 • Number of events 5 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Infections and infestations
Infections and Infestations
|
3.2%
7/219 • Number of events 7 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
2.4%
5/209 • Number of events 5 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
2.7%
6/219 • Number of events 6 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
1.4%
3/209 • Number of events 3 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.00%
0/209 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.8%
4/219 • Number of events 4 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
2.4%
5/209 • Number of events 5 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
2.4%
5/209 • Number of events 5 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Cardiac disorders
Cardiac
|
1.4%
3/219 • Number of events 3 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
2.9%
6/209 • Number of events 6 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Injury, poisoning and procedural complications
Injury
|
1.4%
3/219 • Number of events 3 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
1.4%
3/209 • Number of events 3 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Surgical and medical procedures
Coronary artery bypass graft
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.00%
0/209 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.96%
2/209 • Number of events 2 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
General disorders
Sudden Death
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.00%
0/209 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Investigations
Angiogram
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.00%
0/209 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Vascular disorders
Circulatory collapse
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.00%
0/209 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Blood and lymphatic system disorders
Blood and Lymphatic
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.00%
0/209 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Immune system disorders
Immune System Disorder
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.00%
0/209 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Nervous system disorders
Cerebrovascular accident
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.96%
2/209 • Number of events 2 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Nervous system disorders
hypoglycaemic coma
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.91%
2/219 • Number of events 2 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Nervous system disorders
Headache
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Surgical and medical procedures
lung lobectomy
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Surgical and medical procedures
coronary stent insertion
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Surgical and medical procedures
Amputation revision
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Surgical and medical procedures
Surgery (unspecified)
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Surgical and medical procedures
Spinal fusion Surgery
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Surgical and medical procedures
Aortic valve repair
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
General disorders
Chest Pain
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Investigations
Blood Glucose Fluctuation
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Vascular disorders
Ischaemic Necrosis
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
Other adverse events
| Measure |
Metformin
n=219 participants at risk
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
|
Placebo
n=209 participants at risk
Placebo: 3 years duration 209 of the 428 randomised were assigned to Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
40.2%
88/219 • Number of events 88 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
8.6%
18/209 • Number of events 18 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Cardiac disorders
Cardiovascular
|
0.46%
1/219 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 1 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Nervous system disorders
Neurological
|
0.00%
0/219 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.00%
0/209 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Product Issues
Hypersensitivity to Metformin
|
2.3%
5/219 • Number of events 5 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
0.48%
1/209 • Number of events 5 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
|
Eye disorders
Opthalmic adverse events
|
8.2%
18/219 • Number of events 18 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
15.3%
32/209 • Number of events 32 • Adverse event data collected from the date of consent until 30 days post last IMP dose, an average of 3 years.
Definition used same as clinical trials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place