Impact of FDA guidance for developing diabetes drugs on trial design: From policy to practice

Current Cardiology Reports

Volumn 14, Issue 1, 2012, Pages 59-69

  Bethel, M Angelyn ^a,b   Sourij, Harald ^a,c  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b DUKE UNIVERSITY   (United States)

^c MEDICAL UNIVERSITY OF GRAZ   (Austria)

Author keywords

Cardiovascular outcome; Diabetes drugs; FDA guidance; Outcome trials; Type 2 diabetes

Indexed keywords

ACARBOSE; ALEGLITAZAR; ALOGLIPTIN; ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EXENDIN 4; GLICLAZIDE; GLIPIZIDE; GLITAZONE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1 DERIVATIVE; HEMOGLOBIN A1C; INSULIN; INSULIN GLARGINE; INSULIN LISPRO; ISOPHANE INSULIN; LIXISENATIDE; METFORMIN; MURAGLITAZAR; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR AGONIST; PIOGLITAZONE; PLACEBO; RECOMBINANT HUMAN INSULIN; ROSIGLITAZONE; SAXAGLIPTIN; SITAGLIPTIN; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; SULFONYLUREA; TROGLITAZONE; UNCLASSIFIED DRUG; UNINDEXED DRUG; VITAMIN D;

ACUTE CORONARY SYNDROME; ADD ON THERAPY; ARTICLE; CARDIOVASCULAR EFFECT; CARDIOVASCULAR RISK; CLINICAL TRIAL (TOPIC); DIABETES MELLITUS; DRUG APPROVAL; DRUG CLASSIFICATION; DRUG EFFICACY; DRUG MARKETING; DRUG RECALL; DRUG RESEARCH; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; EVIDENCE BASED MEDICINE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GLUCOSE METABOLISM; HEART INFARCTION; HEMOGLOBIN BLOOD LEVEL; HUMAN; INSULIN SENSITIVITY; LIFESTYLE MODIFICATION; LIVER TOXICITY; MEDICAL DECISION MAKING; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; SAMPLE SIZE; SIDE EFFECT; STANDARD; STROKE; STUDY DESIGN; UNSTABLE ANGINA PECTORIS; WEIGHT GAIN;

CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS; DIABETIC ANGIOPATHIES; FEMALE; GUIDELINE ADHERENCE; HEALTH POLICY; HUMANS; HYPOGLYCEMIC AGENTS; MALE; PRACTICE GUIDELINES AS TOPIC; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84857634931     PISSN: 15233782     EISSN: 15343170     Source Type: Journal    
DOI: 10.1007/s11886-011-0229-7     Document Type: Article

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