REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)
NCT ID: NCT01483560
Last Updated: 2019-06-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
493 participants
INTERVENTIONAL
2011-12-31
2017-04-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes
NCT04583462
EMERALD: Effects of Metformin on Cardiovascular Function in Adolescents With Type 1 Diabetes
NCT01808690
Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes
NCT01497912
Time To Complications Occurs in Diabetes
NCT00969956
Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes
NCT05159856
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Metformin
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
Metformin
3 years treatment duration
Placebo
Placebo
3 years duration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin
3 years treatment duration
Placebo
3 years duration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 40 years or above
* 7.0 =\< HbA1c \<10.0% (53 - 86 mmol/mol)
AND 3 or more of the following ten CardioVascular Disease (CVD) risk factors:
* BMI \>27 kg/m\^2
* Current HbA1c \>8.0% (64 mmol/mol)
* Known CVD/peripheral vascular disease
* Current smoker
* Estimated glomerular filtration rate (eGFR) \<90 ml/min per 1.73 m\^3
* Confirmed micro- or macroalbuminuria \[according to local assays and reference ranges\]
* Hypertension (BP \>=140/90 millimeters of mercury (mmHg) or established on antihypertensive treatment)
* Dyslipidaemia \[total cholesterol \>=5.0 mmol/L (200 mg/dL);OR HDL cholesterol \<1.20 mmol/L (46mg/dL) \[MEN\]; OR \<1.30 mmol/L (50 mg/dL) \[WOMEN\]; or triglycerides \>=1.7 mmol/L (150mg/dL); or established on lipid-lowering treatment)\]
* Strong family history of CVD (at least one parent, biological aunt/ uncle, or sibling with myocardial infarction or stroke aged \<60 years)
* Duration of diabetes \> 20 years
Exclusion Criteria
* woman of childbearing age not on effective contraception
* Pregnancy and/or lactation
* Acute coronary syndrome or Stroke/Transient Ischaemic Attack within the last three months
* NYHA stage 3 or 4 heart failure
* Significant hypoglycaemia unawareness
* Impaired cognitive function/ unable to give informed consent
* Previous carotid surgery/ inability to capture adequate carotid images
* Estimated glomerular filtration \< 45ml/min/1.73m\^2 (MDRD)
* Gastroparesis
* History of lactic acidosis
* Other contraindications to metformin (hepatic impairment, known hypersensitivity to metformin, acute illness such as dehydration, severe infection, shock, acute cardiac failure or suspected tissue hypoxia)
* Any coexistent life threatening condition including prior diagnosis of cancer within two years
* History of alcohol problem or drug abuse
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NHS Greater Glasgow and Clyde
OTHER
Juvenile Diabetes Research Foundation
OTHER
Imperial College London
OTHER
University of Wisconsin, Madison
OTHER
University of Dundee
OTHER
Merck Serono S.A., Geneva
INDUSTRY
Itamar-Medical, Israel
INDUSTRY
University of Western Ontario, Canada
OTHER
University of Melbourne
OTHER
Steno Diabetes Center Copenhagen
OTHER
Maastricht University Medical Center
OTHER
University of Glasgow
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof John Petrie
Clinical Professor in Diabetic Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John Petrie, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Helen Colhoun, Prof
Role: STUDY_DIRECTOR
University of Dundee
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Melbourne Hospital
Melbourne, , Australia
St Vincent's Hospital
Melbourne, , Australia
Royal Prince Albert Hospital
Sydney, , Australia
St Joseph's Health Care
London, Ontario, Canada
Ottawa Hospital Riverside Campus
Ottawa, , Canada
Steno Diabetes Centre
Gentofte Municipality, , Denmark
Maastricht University Medical Centre
Maastricht, , Netherlands
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Ayr Hospital
Ayr, , United Kingdom
University Hospitals Bristol
Bristol, , United Kingdom
Diabetes Support Unit, Ninewells Hospital and Medical School
Dundee, , United Kingdom
University Hospital North Durham
Durham, , United Kingdom
Edinburgh Royal Infirmary
Edinburgh, , United Kingdom
Edinburgh Western Infirmary
Edinburgh, , United Kingdom
Peninsula NIHR Clinical Research Facility, Royal Devon and Exeter NHS Foundation Trust
Exeter, , United Kingdom
Stobhill Hospital, Diabetes Clinic
Glasgow, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Michael White Diabetes Centre, Hull Royal Infirmary
Hull, , United Kingdom
Clinical Sciences Centre, University Hospital
Liverpool, , United Kingdom
Clinical Investigation Unit, International Centre for Circulatory Health, Imperial College Healthcare NHS Trust
London, , United Kingdom
Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary
Manchester, , United Kingdom
Newcastle NIHR Clinical Research Facility, Royal Victoria Hospital
Newcastle, , United Kingdom
Diabetes Clinical Research Centre, Plymouth
Plymouth, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
Petrie JR, Chaturvedi N, Ford I, Brouwers MCGJ, Greenlaw N, Tillin T, Hramiak I, Hughes AD, Jenkins AJ, Klein BEK, Klein R, Ooi TC, Rossing P, Stehouwer CDA, Sattar N, Colhoun HM; REMOVAL Study Group. Cardiovascular and metabolic effects of metformin in patients with type 1 diabetes (REMOVAL): a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Aug;5(8):597-609. doi: 10.1016/S2213-8587(17)30194-8. Epub 2017 Jun 11.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-000300-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GN10DI406
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.