Composite endpoints in trials of type-2 diabetes

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Composite endpoints in trials of type-2 diabetes is …
instance of (P31):
scholarly articleQ13442814

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P356DOI10.1111/DOM.12226
P698PubMed publication ID24148209

P2093author name stringT R Einarson
M Garg
V Kaur
M E H Hemels
P2860cites workDeterminants of weight gain in the action to control cardiovascular risk in diabetes trialQ37022597
The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010.Q37022665
Weighting composite endpoints in clinical trials: essential evidence for the heart teamQ37115639
Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD).Q37235840
Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trialQ37348811
Methodological issues in the use of composite endpoints in clinical trials: examples from the HIV fieldQ37692734
Role of sodium-glucose cotransporter 2 (SGLT 2) inhibitors in the treatment of type 2 diabetes.Q37878715
Barriers to effective insulin treatment: the persistence of poor glycemic control in type 2 diabetesQ37937592
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Proportion of patients at HbA1c target <7% with eight classes of antidiabetic drugs in type 2 diabetes: systematic review of 218 randomized controlled trials with 78 945 patients.Q37940567
Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 studyQ38044043
Efficacy of almotriptan 12.5 mg in achieving migraine-related composite endpoints: a double-blind, randomized, placebo-controlled study in patients controlled study in patients with previous poor response to sumatriptan 50 mg.Q39360286
DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeksQ40718093
Clinical perspectives on the use of composite endpointsQ41668413
Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeksQ41831179
Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemiaQ42613301
A placebo‐controlled trial of exenatide twice‐daily added to thiazolidinediones alone or in combination with metforminQ42846868
Evidence-based urology in practice: composite endpointsQ43018768
A comparison of efficacy and safety of vildagliptin and gliclazide in combination with metformin in patients with Type 2 diabetes inadequately controlled with metformin alone: a 52-week, randomized studyQ43034890
Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trialQ43086322
Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetesQ43187035
Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programmeQ44383427
Efficacy of the Roux-en-Y gastric bypass compared to medically managed controls in meeting the American Diabetes Association composite end point goals for management of type 2 diabetes mellitusQ44579854
Fifty-two-week efficacy and safety of vildagliptin vs. glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapyQ46173840
Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trialQ46344895
Reduced cardiovascular morbidity and mortality associated with metformin use in subjects with Type 2 diabetesQ46401219
Sitagliptin more effectively achieves a composite endpoint for A1C reduction, lack of hypoglycemia and no body weight gain compared with glipizideQ47381999
Pros and Cons of Composite Endpoints in Anesthesia TrialsQ48331262
DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes.Q51379684
Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial.Q51382777
Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial.Q51382898
Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial.Q51478110
Truncated GLP-1 (proglucagon 78-107-amide) inhibits gastric and pancreatic functions in man.Q51601217
Combining composite endpoints: counterintuitive or a mathematical impossibility?Q52020947
Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinationsQ22241134
Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trialQ28277510
Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trialQ28286240
Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trialQ28287325
Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority studyQ28293505
The positive and negative syndrome scale (PANSS) for schizophreniaQ28301751
Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trialQ29619886
Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) studyQ33606579
Liraglutide - overview of the preclinical and clinical data and its role in the treatment of type 2 diabetes.Q33785308
Long-term effects of intensive glucose lowering on cardiovascular outcomesQ33851861
Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU)Q33854032
Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trialQ33999757
Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 studyQ34598940
The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin aloneQ34608300
Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trialQ34610019
Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione aloneQ34613240
One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trQ34893192
Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6).Q34986024
Poor control of risk factors for vascular disease among adults with previously diagnosed diabetesQ35634210
Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind studyQ35688369
Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targetsQ36047167
Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trialQ36249636
Some issues with composite endpoints in clinical trialsQ36324876
Efficacy and safety comparison between liraglutide as add-on therapy to insulin and insulin dose-increase in Chinese subjects with poorly controlled type 2 diabetes and abdominal obesityQ36498624
Exenatide once weekly improved glycaemic control, cardiometabolic risk factors and a composite index of an HbA1c < 7%, without weight gain or hypoglycaemia, over 52 weeksQ36670931
Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiencyQ36782645
Once-weekly exenatide versus once- or twice-daily insulin detemir: randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureasQ36782811
Methodologic discussions for using and interpreting composite endpoints are limited, but still identify major concernsQ36851212
Insulin-associated weight gain in diabetes--causes, effects and coping strategiesQ36966075
P433issue6
P304page(s)492-499
P577publication date2013-11-08
P1433published inDiabetes, Obesity and MetabolismQ5270109
P1476titleComposite endpoints in trials of type-2 diabetes
P478volume16

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cites work (P2860)
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Q47182784Achieving the composite endpoint of HbA1c, body weight, and systolic blood pressure reduction with canagliflozin in patients with type 2 diabetes
Q37334002Achieving the composite endpoint of glycated haemoglobin <7.0%, no weight gain and no hypoglycaemia in the once-weekly dulaglutide AWARD programme
Q42180667Antioxidant strategies in the management of diabetic neuropathy.
Q47296986Blinded sample size recalculation in clinical trials with binary composite endpoints
Q58612825CANadian CAnagliflozin Registry: Effectiveness and Safety of Canagliflozin in the treatment of Type 2 diabetes mellitus in Canadian Clinical Practice
Q47326370Comparison of alogliptin and glipizide for composite endpoint of glycated haemoglobin reduction, no hypoglycaemia and no weight gain in type 2 diabetes mellitus
Q40966874Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT® trial
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Q37257372Effectiveness and safety of glimepiride and iDPP4, associated with metformin in second line pharmacotherapy of type 2 diabetes mellitus: systematic review and meta-analysis.
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Q38931610Sex and age discrepancy of HbA1c and fetal hemoglobin determined by HPLC in a large Chinese Han population
Q36989681Simultaneous Reduction in Both HbA1c and Body Weight with Canagliflozin Versus Glimepiride in Patients with Type 2 Diabetes on Metformin

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