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Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial

Summary Background Dulaglutide and liraglutide, both glucagon-like peptide-1 (GLP-1) receptor agonists, improve glycaemic control and reduce weight in patients with type 2 diabetes. In a head-to-head trial, we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liragl... Full description

Journal Title: The Lancet (British edition) 2014, Vol.384 (9951), p.1349-1357
Main Author: Dungan, Kathleen M, Dr
Other Authors: Povedano, Santiago Tofé, MD , Forst, Thomas, MD , González, José G González, Prof , Atisso, Charles, PhD , Sealls, Whitney, PhD , Fahrbach, Jessie L, MD
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0140-6736
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title: Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial
format: Article
creator:
  • Dungan, Kathleen M, Dr
  • Povedano, Santiago Tofé, MD
  • Forst, Thomas, MD
  • González, José G González, Prof
  • Atisso, Charles, PhD
  • Sealls, Whitney, PhD
  • Fahrbach, Jessie L, MD
subjects:
  • Abridged Index Medicus
  • Analysis of Variance
  • Biological and medical sciences
  • Blood Glucose - metabolism
  • Blood pressure
  • Clinical trials
  • Comparative analysis
  • Diabetes
  • Diabetes Mellitus, Type 2 - blood
  • Diabetes Mellitus, Type 2 - drug therapy
  • Diabetes. Impaired glucose tolerance
  • Drug Administration Schedule
  • Drug dosages
  • Drug therapy
  • Endocrine pancreas. Apud cells (diseases)
  • Endocrinopathies
  • Enzymes
  • Etiopathogenesis. Screening. Investigations. Target tissue resistance
  • Fasting - blood
  • Female
  • General aspects
  • Glucagon-Like Peptide 1 - administration & dosage
  • Glucagon-Like Peptide 1 - adverse effects
  • Glucagon-Like Peptide 1 - analogs & derivatives
  • Glucagon-Like Peptides - administration & dosage
  • Glucagon-Like Peptides - adverse effects
  • Glucagon-Like Peptides - analogs & derivatives
  • Glycated Hemoglobin A - metabolism
  • Humans
  • Hypoglycemic Agents - administration & dosage
  • Hypoglycemic Agents - adverse effects
  • Immunoglobulin Fc Fragments - administration & dosage
  • Immunoglobulin Fc Fragments - adverse effects
  • Internal Medicine
  • Liraglutide
  • Male
  • Medical sciences
  • Metformin - therapeutic use
  • Middle Aged
  • Recombinant Fusion Proteins - administration & dosage
  • Recombinant Fusion Proteins - adverse effects
  • Treatment Outcome
  • Type 2 diabetes
  • Usage
ispartof: The Lancet (British edition), 2014, Vol.384 (9951), p.1349-1357
description: Summary Background Dulaglutide and liraglutide, both glucagon-like peptide-1 (GLP-1) receptor agonists, improve glycaemic control and reduce weight in patients with type 2 diabetes. In a head-to-head trial, we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients with uncontrolled type 2 diabetes. Methods We did a phase 3, randomised, open-label, parallel-group study at 62 sites in nine countries between June 20, 2012, and Nov 25, 2013. Patients with inadequately controlled type 2 diabetes receiving metformin (≥1500 mg/day), aged 18 years or older, with glycated haemoglobin (HbA1c ) 7·0% or greater (≥53 mmol/mol) and 10·0% or lower (≤86 mmol/mol), and body-mass index 45 kg/m2 or lower were randomly assigned to receive once-weekly dulaglutide (1·5 mg) or once-daily liraglutide (1·8 mg). Randomisation was done according to a computer-generated random sequence with an interactive voice response system. Participants and investigators were not masked to treatment allocation. The primary outcome was non-inferiority (margin 0·4%) of dulaglutide compared with liraglutide for change in HbA1c (least-squares mean change from baseline) at 26 weeks. Safety data were collected for a further 4 weeks' follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov , number NCT01624259. Findings We randomly assigned 599 patients to receive once-weekly dulaglutide (299 patients) or once-daily liraglutide (300 patients). 269 participants in each group completed treatment at week 26. Least-squares mean reduction in HbA1c was −1·42% (SE 0·05) in the dulaglutide group and −1·36% (0·05) in the liraglutide group. Mean treatment difference in HbA1c was −0·06% (95% CI −0·19 to 0·07, pnon-inferiority
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleOnce-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial
sourceAlma/SFX Local Collection
creatorDungan, Kathleen M, Dr ; Povedano, Santiago Tofé, MD ; Forst, Thomas, MD ; González, José G González, Prof ; Atisso, Charles, PhD ; Sealls, Whitney, PhD ; Fahrbach, Jessie L, MD
creatorcontribDungan, Kathleen M, Dr ; Povedano, Santiago Tofé, MD ; Forst, Thomas, MD ; González, José G González, Prof ; Atisso, Charles, PhD ; Sealls, Whitney, PhD ; Fahrbach, Jessie L, MD
descriptionSummary Background Dulaglutide and liraglutide, both glucagon-like peptide-1 (GLP-1) receptor agonists, improve glycaemic control and reduce weight in patients with type 2 diabetes. In a head-to-head trial, we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients with uncontrolled type 2 diabetes. Methods We did a phase 3, randomised, open-label, parallel-group study at 62 sites in nine countries between June 20, 2012, and Nov 25, 2013. Patients with inadequately controlled type 2 diabetes receiving metformin (≥1500 mg/day), aged 18 years or older, with glycated haemoglobin (HbA1c ) 7·0% or greater (≥53 mmol/mol) and 10·0% or lower (≤86 mmol/mol), and body-mass index 45 kg/m2 or lower were randomly assigned to receive once-weekly dulaglutide (1·5 mg) or once-daily liraglutide (1·8 mg). Randomisation was done according to a computer-generated random sequence with an interactive voice response system. Participants and investigators were not masked to treatment allocation. The primary outcome was non-inferiority (margin 0·4%) of dulaglutide compared with liraglutide for change in HbA1c (least-squares mean change from baseline) at 26 weeks. Safety data were collected for a further 4 weeks' follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov , number NCT01624259. Findings We randomly assigned 599 patients to receive once-weekly dulaglutide (299 patients) or once-daily liraglutide (300 patients). 269 participants in each group completed treatment at week 26. Least-squares mean reduction in HbA1c was −1·42% (SE 0·05) in the dulaglutide group and −1·36% (0·05) in the liraglutide group. Mean treatment difference in HbA1c was −0·06% (95% CI −0·19 to 0·07, pnon-inferiority <0·0001) between the two groups. The most common gastrointestinal adverse events were nausea (61 [20%] in dulaglutide group vs 54 [18%] in liraglutide group), diarrhoea (36 [12%] vs 36 [12%]), dyspepsia (24 [8%] vs 18 [6%]), and vomiting (21 [7%] vs 25 [8%]), with similar rates of study or study drug discontinuation because of adverse events between the two groups (18 [6%] in each group). The hypoglycaemia rate was 0·34 (SE 1·44) and 0·52 (3·01) events per patient per year, respectively, and no severe hypoglycaemia was reported. Interpretation Once-weekly dulaglutide is non-inferior to once-daily liraglutide for least-squares mean reduction in HbA1c , with a similar safety and tolerability profile. Funding Eli Lilly and Company.
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0Dungan, Kathleen M, Dr
1Povedano, Santiago Tofé, MD
2Forst, Thomas, MD
3González, José G González, Prof
4Atisso, Charles, PhD
5Sealls, Whitney, PhD
6Fahrbach, Jessie L, MD
title
0Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial
1The Lancet (British edition)
addtitleLancet
descriptionSummary Background Dulaglutide and liraglutide, both glucagon-like peptide-1 (GLP-1) receptor agonists, improve glycaemic control and reduce weight in patients with type 2 diabetes. In a head-to-head trial, we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients with uncontrolled type 2 diabetes. Methods We did a phase 3, randomised, open-label, parallel-group study at 62 sites in nine countries between June 20, 2012, and Nov 25, 2013. Patients with inadequately controlled type 2 diabetes receiving metformin (≥1500 mg/day), aged 18 years or older, with glycated haemoglobin (HbA1c ) 7·0% or greater (≥53 mmol/mol) and 10·0% or lower (≤86 mmol/mol), and body-mass index 45 kg/m2 or lower were randomly assigned to receive once-weekly dulaglutide (1·5 mg) or once-daily liraglutide (1·8 mg). Randomisation was done according to a computer-generated random sequence with an interactive voice response system. Participants and investigators were not masked to treatment allocation. The primary outcome was non-inferiority (margin 0·4%) of dulaglutide compared with liraglutide for change in HbA1c (least-squares mean change from baseline) at 26 weeks. Safety data were collected for a further 4 weeks' follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov , number NCT01624259. Findings We randomly assigned 599 patients to receive once-weekly dulaglutide (299 patients) or once-daily liraglutide (300 patients). 269 participants in each group completed treatment at week 26. Least-squares mean reduction in HbA1c was −1·42% (SE 0·05) in the dulaglutide group and −1·36% (0·05) in the liraglutide group. Mean treatment difference in HbA1c was −0·06% (95% CI −0·19 to 0·07, pnon-inferiority <0·0001) between the two groups. The most common gastrointestinal adverse events were nausea (61 [20%] in dulaglutide group vs 54 [18%] in liraglutide group), diarrhoea (36 [12%] vs 36 [12%]), dyspepsia (24 [8%] vs 18 [6%]), and vomiting (21 [7%] vs 25 [8%]), with similar rates of study or study drug discontinuation because of adverse events between the two groups (18 [6%] in each group). The hypoglycaemia rate was 0·34 (SE 1·44) and 0·52 (3·01) events per patient per year, respectively, and no severe hypoglycaemia was reported. Interpretation Once-weekly dulaglutide is non-inferior to once-daily liraglutide for least-squares mean reduction in HbA1c , with a similar safety and tolerability profile. Funding Eli Lilly and Company.
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1Analysis of Variance
2Biological and medical sciences
3Blood Glucose - metabolism
4Blood pressure
5Clinical trials
6Comparative analysis
7Diabetes
8Diabetes Mellitus, Type 2 - blood
9Diabetes Mellitus, Type 2 - drug therapy
10Diabetes. Impaired glucose tolerance
11Drug Administration Schedule
12Drug dosages
13Drug therapy
14Endocrine pancreas. Apud cells (diseases)
15Endocrinopathies
16Enzymes
17Etiopathogenesis. Screening. Investigations. Target tissue resistance
18Fasting - blood
19Female
20General aspects
21Glucagon-Like Peptide 1 - administration & dosage
22Glucagon-Like Peptide 1 - adverse effects
23Glucagon-Like Peptide 1 - analogs & derivatives
24Glucagon-Like Peptides - administration & dosage
25Glucagon-Like Peptides - adverse effects
26Glucagon-Like Peptides - analogs & derivatives
27Glycated Hemoglobin A - metabolism
28Humans
29Hypoglycemic Agents - administration & dosage
30Hypoglycemic Agents - adverse effects
31Immunoglobulin Fc Fragments - administration & dosage
32Immunoglobulin Fc Fragments - adverse effects
33Internal Medicine
34Liraglutide
35Male
36Medical sciences
37Metformin - therapeutic use
38Middle Aged
39Recombinant Fusion Proteins - administration & dosage
40Recombinant Fusion Proteins - adverse effects
41Treatment Outcome
42Type 2 diabetes
43Usage
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2Forst, Thomas, MD
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4Atisso, Charles, PhD
5Sealls, Whitney, PhD
6Fahrbach, Jessie L, MD
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titleOnce-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial
authorDungan, Kathleen M, Dr ; Povedano, Santiago Tofé, MD ; Forst, Thomas, MD ; González, José G González, Prof ; Atisso, Charles, PhD ; Sealls, Whitney, PhD ; Fahrbach, Jessie L, MD
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0Abridged Index Medicus
1Analysis of Variance
2Biological and medical sciences
3Blood Glucose - metabolism
4Blood pressure
5Clinical trials
6Comparative analysis
7Diabetes
8Diabetes Mellitus, Type 2 - blood
9Diabetes Mellitus, Type 2 - drug therapy
10Diabetes. Impaired glucose tolerance
11Drug Administration Schedule
12Drug dosages
13Drug therapy
14Endocrine pancreas. Apud cells (diseases)
15Endocrinopathies
16Enzymes
17Etiopathogenesis. Screening. Investigations. Target tissue resistance
18Fasting - blood
19Female
20General aspects
21Glucagon-Like Peptide 1 - administration & dosage
22Glucagon-Like Peptide 1 - adverse effects
23Glucagon-Like Peptide 1 - analogs & derivatives
24Glucagon-Like Peptides - administration & dosage
25Glucagon-Like Peptides - adverse effects
26Glucagon-Like Peptides - analogs & derivatives
27Glycated Hemoglobin A - metabolism
28Humans
29Hypoglycemic Agents - administration & dosage
30Hypoglycemic Agents - adverse effects
31Immunoglobulin Fc Fragments - administration & dosage
32Immunoglobulin Fc Fragments - adverse effects
33Internal Medicine
34Liraglutide
35Male
36Medical sciences
37Metformin - therapeutic use
38Middle Aged
39Recombinant Fusion Proteins - administration & dosage
40Recombinant Fusion Proteins - adverse effects
41Treatment Outcome
42Type 2 diabetes
43Usage
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6Fahrbach, Jessie L, MD
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1Povedano, Santiago Tofé, MD
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atitleOnce-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial
jtitleThe Lancet (British edition)
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abstractSummary Background Dulaglutide and liraglutide, both glucagon-like peptide-1 (GLP-1) receptor agonists, improve glycaemic control and reduce weight in patients with type 2 diabetes. In a head-to-head trial, we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients with uncontrolled type 2 diabetes. Methods We did a phase 3, randomised, open-label, parallel-group study at 62 sites in nine countries between June 20, 2012, and Nov 25, 2013. Patients with inadequately controlled type 2 diabetes receiving metformin (≥1500 mg/day), aged 18 years or older, with glycated haemoglobin (HbA1c ) 7·0% or greater (≥53 mmol/mol) and 10·0% or lower (≤86 mmol/mol), and body-mass index 45 kg/m2 or lower were randomly assigned to receive once-weekly dulaglutide (1·5 mg) or once-daily liraglutide (1·8 mg). Randomisation was done according to a computer-generated random sequence with an interactive voice response system. Participants and investigators were not masked to treatment allocation. The primary outcome was non-inferiority (margin 0·4%) of dulaglutide compared with liraglutide for change in HbA1c (least-squares mean change from baseline) at 26 weeks. Safety data were collected for a further 4 weeks' follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov , number NCT01624259. Findings We randomly assigned 599 patients to receive once-weekly dulaglutide (299 patients) or once-daily liraglutide (300 patients). 269 participants in each group completed treatment at week 26. Least-squares mean reduction in HbA1c was −1·42% (SE 0·05) in the dulaglutide group and −1·36% (0·05) in the liraglutide group. Mean treatment difference in HbA1c was −0·06% (95% CI −0·19 to 0·07, pnon-inferiority <0·0001) between the two groups. The most common gastrointestinal adverse events were nausea (61 [20%] in dulaglutide group vs 54 [18%] in liraglutide group), diarrhoea (36 [12%] vs 36 [12%]), dyspepsia (24 [8%] vs 18 [6%]), and vomiting (21 [7%] vs 25 [8%]), with similar rates of study or study drug discontinuation because of adverse events between the two groups (18 [6%] in each group). The hypoglycaemia rate was 0·34 (SE 1·44) and 0·52 (3·01) events per patient per year, respectively, and no severe hypoglycaemia was reported. Interpretation Once-weekly dulaglutide is non-inferior to once-daily liraglutide for least-squares mean reduction in HbA1c , with a similar safety and tolerability profile. Funding Eli Lilly and Company.
copKidlington
pubElsevier Ltd
pmid25018121
doi10.1016/S0140-6736(14)60976-4