Metformin XR for Atherogenesis

Phase-Based Estimates
3
Effectiveness
3
Safety
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha, NE
Atherogenesis+2 More
Metformin XR - Drug
Eligibility
18+
All Sexes
Eligible conditions
Atherogenesis

Study Summary

This study is evaluating whether metformin reduces the risk of death, heart attacks, and/or strokes in patients who have pre-diabetes and heart or blood vessel problems.

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Eligible Conditions

  • Atherogenesis
  • Atherosclerosis
  • Prediabetic State
  • Metformin

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Metformin XR will improve 1 primary outcome and 3 secondary outcomes in patients with Atherogenesis. Measurement will happen over the course of through study completion, an average of 4.5 years.

Year 5
Time in days to Cardiovascular Outcomes
Time in days to Diabetes Outcome
Time in days to Oncologic Outcome
Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Metformin IR to XR
Diarrhoea
75%
Muscular Weakness
25%
Nausea
25%
Muscle Injury
8%
Abnormal Faeces
8%
Urinary tract Infection
8%
Headache
8%
Dyspepsia
8%
Dizziness
8%
Blood pressure Decreased
8%
Decreased Appetite
8%
Abdominal Pain Upper
8%
Abdominal Pain
8%
Pain in Extremity
8%
White Blood Cell Count Decreased
0%
Non-Cardiac Chest Pain
0%
Blood Potassium Increased
0%
Blood Triglycerides Increased
0%
Musculoskeletal Pain
0%
Eye Ulcer
0%
Constipation
0%
Thrombocytosis
0%
Flatulence
0%
Muscle Strain
0%
Liver Function Test Abnormal
0%
Electrocardiogram ST Segment Depression
0%
Listless
0%
Renal Cyst
0%
Nephrolithiasis
0%
Cough
0%
Gastrooesophageal Reflux Disease
0%
Abdominal Distension
0%
Cardiac failure chronic
0%
Liver injury
0%
Palpitations
0%
Chest Disconfort
0%
Hangover
0%
Drug Hypersensitivity
0%
Electrocardiogram Abnormal
0%
Electrocardiogram T Wave Amplitude Decreased
0%
Hyperuricaemia
0%
Hypoglycaemia
0%
Gastritis
0%
Prostatic Calcification
0%
Dysgeusia
0%
Head Discomfort
0%
Electrocardiogram T Wave Abnormal
0%
Haemorrhoids
0%
Angina pectoris
0%
Hypertension
0%
Asthenia
0%
Tachycardia
0%
Brain neoplasm
0%
Defaecation urgency
0%
Pyrexia
0%
Food Poisoning
0%
Urine Ketone Body Present
0%
Electrolyte Imbalance
0%
Dyslipidaemia
0%
Renal Impairment
0%
Dyspnoea
0%
Foot fracture
0%
Eructation
0%
Hiccups
0%
Blood Bilirubin increased
0%
Protein Urine Present
0%
Cerebral Ischaemia
0%
Bowel Movement Irregularity
0%
Hyperhidrosis
0%
Blood Glucose Decreased
0%
Blood glucose increased
0%
Chest pain
0%
Initial Insomnia
0%
Hepatic Function Abnormal
0%
Haemangioma of liver
0%
Herpes Zoster
0%
Spinal Osteoarthritis
0%
Electrocardiogram ST Segment Elevation
0%
Platelet Count Decreased
0%
Back pain
0%
Benign Prostatic Hyperplasia
0%
Blood uric Acid Increased
0%
Alanine Aminotransferase Increased
0%
Frequent Bowel Movements
0%
Hyperlipidaemia
0%
Paraesthesia
0%
Fatigue
0%
Nasopharyngitis
0%
Inner Ear Disorder
0%
Blood Potassium Decreased
0%
Dry mouth
0%
Gastric PH Decreased
0%
Periphatic Discomfort
0%
Cholelithiasis
0%
Sinus bradycardia
0%
Alopecia
0%
Cardiac Discomfort
0%
Faeces Discoloured
0%
Retinal detachment
0%
Adrenal adenoma
0%
Right Ventricular Hypertrophy
0%
Thyroiditis
0%
Cataract
0%
Visual Acuity Reduced
0%
Faeces Hard
0%
Cholecystitis Chronic
0%
Vomiting
0%
Oedema Peripheral
0%
Aspartate Aminotransferase Increased
0%
Hepatic Steatosis
0%
Hypersensitivity
0%
Chronic Hepatitis B
0%
Gastroenteritis
0%
Upper Respiratory Tract Infection
0%
White Blood Cell Count Increased
0%
Blood Sodium Increased
0%
Low Density Lipoprotein Increased
0%
Weight Decreased
0%
Periarthritis
0%
Libido Decreased
0%
Erythema
0%
Generalized Erythema
0%
Pigmentation Disorder
0%
Pruritus
0%
Blood ketone body increased
0%
Abdominal Discomfort
0%
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT02252965) in the Metformin IR to XR ARM group. Side effects include: Diarrhoea with 75%, Muscular Weakness with 25%, Nausea with 25%, Muscle Injury with 8%, Abnormal Faeces with 8%.

Trial Design

2 Treatment Groups

Placebo
Metformin
Placebo group

This trial requires 7410 total participants across 2 different treatment groups

This trial involves 2 different treatments. Metformin XR is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Metformin
Drug
Participants receive initial treatment with metformin XR 500 mg 1 tablet daily, with stepwise titration to a maximum dose of 2000 mg (4 tablets) daily.
Placebo
Drug
Participants receive initial treatment with 1 tablet daily of placebo (for metformin XR), with stepwise titration to a maximum of 4 tablets daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 4.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 4.5 years for reporting.

Closest Location

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE - Omaha, NE

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg/dL; or a 2-hour plasma glucose level of 140-199 mg/dL following a 75 g glucose load oral glucose tolerance test.
Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation.
History of myocardial infarction at least one month prior to randomization.
You have a history of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization. show original
You have a significant coronary stenosis of at least 50% in two major epicardial coronary arteries. show original
You have a documented prior ischemic stroke. show original
Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s)
You have asymptomatic carotid stenosis of at least 70% luminal diameter. show original
History of carotid revascularization (surgical or catheter-based).
History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does metformin xr usually treat?

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Current evidence suggests that long-term use of metformin xr may lead to reductions in serum HbA1c and waist circumference in patients with type 2 diabetes.

Unverified Answer

What is atherogenesis?

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Atherogenesis is a disease of the vessels found in the circulatory system of multicellular organisms. This includes arteries, arterioles, and veins. Arterial plaque, the hard, calcified part of a cholesterol-rich deposit, can form deposits at the location of high blood pressures in a process called haemostasis. Atherogenesis can begin anywhere in the circulatory system, but is most commonly found in arteries of the extremities and thoracic aorta.

Unverified Answer

What causes atherogenesis?

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Findings from a recent study indicates that factors other than increased level of cholesterol, the classical major risk factor for atherogenesis, may play a major role. Findings from a recent study from this study support the inclusion of some of the established risk factors in future risk assessment tools for atherogenesis.

Unverified Answer

How many people get atherogenesis a year in the United States?

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Approximately 250,000 people in the United States are diagnosed with atherogenesis a year. The prevalence of cardiovascular disease, type 1 diabetes, and stroke will all increase in those diagnosed with atherogenesis.

Unverified Answer

What are the signs of atherogenesis?

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Atherogenesis is commonly assessed by means of the ankle-brachial index, which allows to show peripheral arterial dysfunction in patients with arterial disease. The ankle-brachial index should be measured in patients with suspected [coronary artery syndrome] due to atherogenesis. [Power(https://www.withpower.

Unverified Answer

What are common treatments for atherogenesis?

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A significant proportion of patients will be using a combination of five or more conventional medications. The extent of prescribing and dosing should be addressed with practitioners and pharmacists, and any unused medications can be taken up or donated from the community if necessary.

Unverified Answer

Can atherogenesis be cured?

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To prevent coronary atherosclerosis, the following lifestyle modifications may be useful for those with diabetes: 1. control of obesity, 2. exercise, 3. avoidance of high cholesterol diet, 4. reduction of high blood pressure, and 5. control of blood glucose levels in diabetic patients. Exercise may lead to a reduced risk of atherosclerosis.

Unverified Answer

Have there been other clinical trials involving metformin xr?

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There were no reported major clinical trials of metformin/saxenda combination therapy and they may be difficult to find in medical journals because there are only few adverse events reported. It is possible that trials using Saxenda are on file for unpublished data with the EMA. Saxenda received fast track designation from the EMA in 2009 and was granted a new drug application filing in 2014. As of May 2015 it is still under clinical trial.

Unverified Answer

What are the common side effects of metformin xr?

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This is the first analysis of metformin xr side effects. Mild side effects were uncommon, and those side effects that were reported predominantly occurred in women. Common side effects in women included headache, diarrhoea, nausea and, somewhat surprisingly in people given metformin xr for many years, a slight improvement in overweight (5.2%). Commonside effects in men were similarly predictable and were mild and included loss of appetite, diarrhoea, and, as expected in men taking metformin xr for many years, loss of weight.

Unverified Answer

Is metformin xr typically used in combination with any other treatments?

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Metformin xr is commonly used with concomitant statin therapy and antihypertensive agents. Other medications used in combination with metformin xr include oral hypoglycemic agents, insulin, antiplatelet agents, and anticoagulants.

Unverified Answer

What are the latest developments in metformin xr for therapeutic use?

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The most recent developments in metformin xr include the possibility that metformin xr can lower the risk of cardiovascular disease, and there are several reports and articles supporting this effect. As an example, in a systematic review of two randomized trials that investigated the efficacy and safety of metformin vs. placebo, it was reported that metformin decreased the risk of cardiovascular disease, particularly in women with diabetes. In addition, these two trials showed that metformin and metformin xr were equally effective in lowering HbA(1c) (glycemic control).

Unverified Answer

What is metformin xr?

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There was no significant difference, with all students in both the first year and second year, regarding the effects of metformin xr. More studies have to be conducted on larger numbers of students. Moreover, the effect of metformin xr over the next two or so years have to be investigated.

Unverified Answer
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