Trial · NCT01483560
REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)
NCT01483560, Phase 3, Completed, University of Glasgow; results first posted 2019-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL). Trials, record NCT01483560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01483560
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)
- NCT number
- NCT01483560
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 493 participants, actual
- Lead sponsor
- University of Glasgow
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Metformin, Placebo
- First posted
- 2011-12-01
- Last updated
- 2019-06-19
- Other registries' IDs
- eudract:2011-000300-18
- Results first posted
- 2019-06-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | 0, 12 months, 24 months, 36 months | 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. |
| Secondary | Change in HbA1c | Baseline, Year 3 | Measured in accredited local laboratories participating in DCCT-aligned quality control programmes. |
| Secondary | Change in LDL Cholesterol | Baseline, Year 3 | mmol/L Centrally assayed at the University of Glasgow |
| Secondary | Change in Estimated Glomerular Filtration Rate | Baseline, Year 1, Year 2, Year 3 | Number of participants developing new microalbuminuria; change in absolute concentration Calculated using the MDRD equation1 based on creatinine measured in accredited local laboratories |
| Secondary | Number of Participants With Retinopathy and at Least a 2 Stage Progression in Retinopathy From Baseline to 36 Months | Baseline, Year 3 | Two 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. |
| Secondary | Change in Weight | Baseline, Year 1, Year 2, Year 3 | Measured at sites using calibrated weighing scales |
| Secondary | Change in Insulin Dose | Baseline, Year 1, Year 2, Year 3 | Units/ kg body weight Extracted by study nurses from the Study Diary and reported on the study CRF using dedicated fields |
| Secondary | Change in Endothelial Function | Baseline, Year 1, Year 3 | In some centres (Arbitrary units) Reactive Hyperaemia Index using the ENDOPAT device (Itamar, Israel) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | 0, 12 months, 24 months, 36 months | mm | MEAN | |
| SECONDARY | Change in HbA1c | Baseline, Year 3 | %units | MEAN | |
| SECONDARY | Change in LDL Cholesterol | Baseline, Year 3 | mmol/L | MEAN | |
| SECONDARY | Change in Estimated Glomerular Filtration Rate | Baseline, Year 1, Year 2, Year 3 | ml/min/1.73m2 | MEAN | |
| SECONDARY | Number of Participants With Retinopathy and at Least a 2 Stage Progression in Retinopathy From Baseline to 36 Months | Baseline, Year 3 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Weight | Baseline, Year 1, Year 2, Year 3 | kg | MEAN | |
| SECONDARY | Change in Insulin Dose | Baseline, Year 1, Year 2, Year 3 | units/kg | MEAN | |
| SECONDARY | Change in Endothelial Function | Baseline, Year 1, Year 3 | RHI (Arbitrary units) | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | Metformin | Baseline | 0.773 | Standard Deviation 0.14 | mm |
| Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | Placebo | Baseline | 0.791 | Standard Deviation 0.183 | mm |
| Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | Metformin | 12 Months | 0.782 | Standard Deviation 0.147 | mm |
| Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | Placebo | 12 Months | 0.788 | Standard Deviation 0.174 | mm |
| Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | Metformin | 24 Months | 0.792 | Standard Deviation 0.145 | mm |
| Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | Placebo | 24 Months | 0.823 | Standard Deviation 0.187 | mm |
| Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | Metformin | 36 Months | 0.793 | Standard Deviation 0.134 | mm |
| Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT) | Placebo | 36 Months | 0.820 | Standard Deviation 0.177 | mm |
| Change in HbA1c | Metformin | Baseline | 8.1 | Standard Deviation 0.9 | %units |
| Change in HbA1c | Placebo | Baseline | 8.0 | Standard Deviation 0.8 | %units |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metformin | 219 | |
| Overall Study | STARTED | Placebo | 209 | |
| Overall Study | COMPLETED | Metformin | 193 | |
| Overall Study | COMPLETED | Placebo | 194 | |
| Overall Study | NOT COMPLETED | Metformin | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 15 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal | Gastrointestinal disorders | Metformin | 88 | 219 | 88 |
| other | Gastrointestinal | Gastrointestinal disorders | Placebo | 18 | 209 | 18 |
| other | Cardiovascular | Cardiac disorders | Metformin | 1 | 219 | 1 |
| other | Cardiovascular | Cardiac disorders | Placebo | 1 | 209 | 1 |
| other | Neurological | Nervous system disorders | Metformin | 0 | 219 | 0 |
| other | Neurological | Nervous system disorders | Placebo | 0 | 209 | 0 |
| other | Hypersensitivity to Metformin | Product Issues | Metformin | 5 | 219 | 5 |
| other | Hypersensitivity to Metformin | Product Issues | Placebo | 1 | 209 | 5 |
| other | Opthalmic adverse events | Eye disorders | Metformin | 18 | 219 | 18 |
| other | Opthalmic adverse events | Eye disorders | Placebo | 32 | 209 | 32 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin | 5 | 219 |
| Total, all-cause mortality | Placebo | 2 | 209 |
| Total, other adverse events | Metformin | 112 | 219 |
| Total, other adverse events | Placebo | 52 | 209 |
| Total, serious adverse events | Metformin | 34 | 219 |
| Total, serious adverse events | Placebo | 31 | 209 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Metformin vs Placebo: deaths from any cause | Trial comparisons |
| Metformin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01483560
GET https://conductscience.org/api/trials/v1/NCT01483560/results?page=2