Status:
COMPLETED
REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)
Lead Sponsor:
University of Glasgow
Collaborating Sponsors:
NHS Greater Glasgow and Clyde
Juvenile Diabetes Research Foundation
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The trial is conducted in the United Kingdom (UK), Australia, Canada, Denmark and the Netherlands. The aim is to test whether 3 years treatment with metformin added to titrated insulin therapy (toward...
Eligibility Criteria
Inclusion
- Type 1 Diabetes for five years or more\*
- Age 40 years or above
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2017
Estimated Enrollment :
493 Patients enrolled
Trial Details
Trial ID
NCT01483560
Start Date
December 1 2011
End Date
April 18 2017
Last Update
June 19 2019
Active Locations (24)
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1
Royal Melbourne Hospital
Melbourne, Australia
2
St Vincent's Hospital
Melbourne, Australia
3
Royal Prince Albert Hospital
Sydney, Australia
4
St Joseph's Health Care
London, Ontario, Canada