REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)
Overview[ - collapse ][ - ]
Purpose | The trial is conducted in the UK, Australia, Canada, Denmark and the Netherlands. The aim is to test whether 3 years treatment with metformin added to titrated insulin therapy (towards target HbA1c7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid IMT, in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for cardiovascular disease. |
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Condition | Diabetes Mellitus, Type 1 |
Intervention | Drug: Metformin Drug: Placebo |
Phase | Phase 3 |
Sponsor | University of Glasgow |
Responsible Party | University of Glasgow |
ClinicalTrials.gov Identifier | NCT01483560 |
First Received | November 23, 2011 |
Last Updated | April 1, 2013 |
Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | November 23, 2011 |
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Last Updated Date | April 1, 2013 |
Start Date | December 2011 |
Estimated Primary Completion Date | December 2016 |
Current Primary Outcome Measures | Change in averaged mean far wall common carotid artery IMT [Time Frame: 0, 12 months, 24 months, 36 months] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL) |
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Official Title | Phase 3 Study of Metformin in Adults With Type 1 Diabetes |
Brief Summary | The trial is conducted in the UK, Australia, Canada, Denmark and the Netherlands. The aim is to test whether 3 years treatment with metformin added to titrated insulin therapy (towards target HbA1c7.0%/53 mmol/mol) reduces atherosclerosis, as measured by progression of carotid IMT, in adults with confirmed type 1 diabetes aged 40 years and over at increased risk for cardiovascular disease. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 1 |
Intervention | Drug: Metformin 3 years treatment duration Other Names: GlucophageDrug: Placebo 3 years duration |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 500 |
Estimated Completion Date | December 2016 |
Estimated Primary Completion Date | October 2016 |
Eligibility Criteria | Inclusion Criteria: - Type 1 Diabetes for five years or more* - Age 40 years or above - 7.0 =< HbA1c <10.0% (53 - 86 mmol/mol) AND 3 or more of the following ten 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 <90 ml/min per 1.73 m^3 - Confirmed micro- or macroalbuminuria [according to local assays and reference ranges] - Hypertension (BP >=140/90mmHg 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: - eGFR < 45 ml/min/1.73m2 - 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 |
Gender | Both |
Ages | 40 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: John Petrie 00 44 141 330 3325 john.petrie@glasgow.ac.uk |
Location Countries | Australia, Canada, Denmark, Netherlands, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01483560 |
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Other Study ID Numbers | GN10DI406 |
Has Data Monitoring Committee | Yes |
Information Provided By | University of Glasgow |
Study Sponsor | University of Glasgow |
Collaborators | NHS Greater Glasgow and Clyde Juvenile Diabetes Research Foundation Imperial College London University of Wisconsin School of Medicine and Public Health University of Dundee Merck Serono S.A., Geneva Itamar-Medical, Israel University of Western Ontario, Canada University of Melbourne Steno Diabetes Center Maastricht University Medical Center |
Investigators | Principal Investigator: John Petrie, Prof University of GlasgowStudy Director: Helen Colhoun, Prof University of Dundee |
Verification Date | April 2013 |
Locations[ + expand ][ + ]
St Vincent's Hospital | Melbourne, Australia Contact: Alicia Jenkins | jenkinsa@medstv.unimelb.edu.auPrincipal Investigator: Alicia Jenkins Recruiting |
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Royal Melbourne Hospital | Melbourne, Australia Contact: Peter Colman | peter.colman@mh.org.auPrincipal Investigator: Peter Colman Recruiting |
Royal Prince Albert Hospital | Sydney, Australia Contact: Stephen Twigg | stwigg@med.usyd.edu.auPrincipal Investigator: Stephen Twigg Recruiting |
St Joseph's Health Care | Ontario, Canada Contact: Irene Hramiak | irene.hramiak@sjhc.london.on.caPrincipal Investigator: Irene Hramiak Recruiting |
Ottawa Hospital Riverside Campus | Ottawa, Canada Contact: TC Ooi | tcooi@toh.on.caPrincipal Investigator: TC Ooi Not yet recruiting |
Steno Diabetes Centre | Gentofte, Denmark Contact: Peter Rossing | ltar@steno.dkPrincipal Investigator: Peter Rossing Not yet recruiting |
Maastricht University Medical Centre | Maastricht, Netherlands Contact: Coen Stehouwer | cda.stehouwer@mumc.nlPrincipal Investigator: Coen Stehouwer Recruiting |
Aberdeen Royal Infirmary | Aberdeen, United Kingdom Contact: Donald Pearson | donald.pearson@nhs.netPrincipal Investigator: Donald Pearson Not yet recruiting |
Diabetes Support Unit, Ninewells Hospital and Medical School | Dundee, United Kingdom Contact: Graham Leese | graham.leese@nhs.netPrincipal Investigator: Graham Leese Recruiting |
University Hospital North Durham | Durham, United Kingdom Contact: Kamal Abouglilia | kamal.abouglila@cddft.nhs.ukPrincipal Investigator: Kamal Abouglilia Recruiting |
Edinburgh Western Infirmary | Edinburgh, United Kingdom Contact: John McKnight | john.mcknight@nhs.netPrincipal Investigator: John McKnight Not yet recruiting |
Edinburgh Royal Infirmary | Edinburgh, United Kingdom Contact: Alan Jaap | alan.jaap@nhslothian.scot.nhs.ukPrincipal Investigator: Alan Jaap Not yet recruiting |
Peninsula NIHR Clinical Research Facility, Royal Devon and Exeter NHS Foundation Trust | Exeter, United Kingdom Contact: Roderick Warren | roderick.warren@nhs.netPrincipal Investigator: Roderick Warren Recruiting |
Stobhill Hospital, Diabetes Clinic | Glasgow, United Kingdom Contact: John Petrie | 0044 141 330 3325 | john.petrie@glasgow.ac.ukPrincipal Investigator: Gerard McKay Recruiting |
Michael White Diabetes Centre, Hull Royal Infirmary | Hull, United Kingdom Contact: Steve Atkin | stephen.atkin@hyms.ac.ukPrincipal Investigator: Steve Atkin Recruiting |
Clinical Sciences Centre, University Hospital | Liverpool, United Kingdom Contact: John Wilding | j.p.h.wilding@liverpool.ac.ukPrincipal Investigator: John Wilding Not yet recruiting |
Clinical Investigation Unit, International Centre for Circulatory Health, Imperial College Healthcare NHS Trust | London, United Kingdom Contact: Nick Oliver | nick.oliver@imperial.ac.ukPrincipal Investigator: Nick Oliver Recruiting |
Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary | Manchester, United Kingdom Contact: Rob Davies | rob.davies@cmft.nhs.ukPrincipal Investigator: Martin Gibson Recruiting |
Newcastle NIHR Clinical Research Facility, Royal Victoria Hospital | Newcastle, United Kingdom Contact: Mark Walker | mark.walker@newcastle.ac.ukPrincipal Investigator: Mark Walker Recruiting |
Diabetes Clinical Research Centre, Plymouth | Plymouth, United Kingdom Contact: Ann Millward | ann.millward@pms.ac.ukPrincipal Investigator: Ann Millward Recruiting |
Salford Royal NHS Foundation Trust | Salford, United Kingdom Contact: Martin Gibson | martin.gibson@manchester.ac.ukPrincipal Investigator: Martin Gibson Recruiting |