Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatments metformin, placebo
Phase phase 3
Sponsor University of Glasgow
Collaborator NHS Greater Glasgow and Clyde
Start date December 2011
End date March 2017
Trial size 502 participants
Trial identifier NCT01483560, 2011-000300-18, GN10DI406

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily
metformin Glucophage
3 years treatment duration
(Placebo Comparator)
placebo
3 years duration

Primary Outcomes

Measure
Change in averaged mean far wall common carotid artery IMT
time frame: 0, 12 months, 24 months, 36 months

Secondary Outcomes

Measure
Change in HbA1c
time frame: Baseline, Year 1, Year 2, Year 3
Change in LDL Cholesterol
time frame: Baseline, Year 1, Year 2, Year 3
Change in albuminuria & estimated glomerular filtration rate
time frame: Baseline, Year 1, Year 2, Year 3
Change in retinopathy stage
time frame: Baseline, Year 3
Change in weight
time frame: Baseline, Year 1, Year 2, Year 3
Change in insulin dose
time frame: Baseline, Year 1, Year 2, Year 3
Change in endothelial function
time frame: Baseline, Year 1, Year 3

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Phase 3 Study of Metformin in Adults With Type 1 Diabetes
Principal investigator John Petrie, Prof
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Glasgow.