Efficacy and safety of once‐weekly glucagon‐like peptide 1 receptor agonist albiglutide (<scp>HARMONY</scp> 1 trial): 52‐week primary endpoint results from a randomized, double‐blind, placebo‐controlled trial in patients with type 2 diabetes mellitus not controlled on pioglitazone, with or without metformin

Reusch, Jane E.B.; Stewart, Murray; Perkins, Christopher; Cirkel, Deborah T.; Ye, J.; Perry, Caroline M.; Reinhardt, Rickey R.; Bode, Bruce W.

doi:10.1111/dom.12382

Cited by 92 publications

(70 citation statements)

References 17 publications

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“…[24][25][26][27][28][29][30] In the HARMONY 1 trial, 310 patients undergoing a regimen of pioglitazone plus or minus metformin were assigned to receive albiglutide 30 mg QW or matching placebo and followed up for 52 weeks. 20 Albiglutide-treated patients achieved a significantly larger reduction from mean baseline HbA 1c at week 52 compared with placebo (-0.8% and -0.1%, respectively). The treatment difference of 0.8% was statistically significant (P o 0.0001).…”

Section: Albiglutidementioning

confidence: 87%

“…At 3 years, patients receiving exenatide QW achieved a significant mean reduction in HbA 1c compared with patients receiving insulin glargine (-1.01% and -0.81%, respectively; treatment difference, -0.20%; P ¼ 0.03). 20 Gastrointestinal events occurred more frequently in patients assigned to receive exenatide QW; however, the adjusted rate of hypoglycemia favored exenatide QW.…”

Section: Duration-3 Enrolled 456 Patients (Aged Z18mentioning

confidence: 98%

“…These trials are collectively known as the DURATION (Diabetes Therapy Utilization: Researching Changes in A1C, Weight and Other Factors Through Intervention with Exenatide Once Weekly) trials ( Table I). [16][17][18][19][20][21][22][23] DURATION-1 was a 52-week trial that was completed in 2 phases. 12,13 The first 30 weeks comprised a randomized, open-label comparison in which 295 patients received either exenatide 5 mg BID for the first 28 days, followed by a required dose increase to Clinical Therapeutics 10 mg BID until the end of the 30-week treatment period, or exenatide 2 mg QW.…”

Section: Summary Of Clinical Trials Exenatide Qwmentioning

confidence: 99%

See 2 more Smart Citations

Emerging New Therapies for the Treatment of Type 2 Diabetes Mellitus: Glucagon-like Peptide-1 Receptor Agonists

Lindamood

Taylor

2015

Clinical Therapeutics

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Section: Albiglutidementioning

confidence: 87%

Section: Duration-3 Enrolled 456 Patients (Aged Z18mentioning

confidence: 98%

Section: Summary Of Clinical Trials Exenatide Qwmentioning

confidence: 99%

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Emerging New Therapies for the Treatment of Type 2 Diabetes Mellitus: Glucagon-like Peptide-1 Receptor Agonists

Lindamood

Taylor

2015

Clinical Therapeutics

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“…if there is inadequate glycemic response [3]. Several Phase III clinical trials have compared the improvement in glycated hemoglobin (HbA 1c ) levels with albiglutide versus that of placebo or other antidiabetic agents in different disease settings [4][5][6][7][8][9][10][11].…”

mentioning

confidence: 99%

“…The multinational HARMONY Phase III clinical trial program [4][5][6][7][8][9][10][11] evaluated albiglutide alone or in combination with commonly used T2DM treatments. The HARMONY future science group…”

mentioning

confidence: 99%

Real-world comparison of treatment patterns and effectiveness of albiglutide and liraglutide

et al. 2018

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Aim:To compare medication adherence, discontinuation and glycemic control in patients receiving albiglutide versus liraglutide. Patients & methods: Administrative claims data and glycated hemoglobin (HbA 1c ) results were analyzed from a sample of adult health plan members with Type 2 diabetes. Results: Patients were matched 1:1 in the albiglutide (n = 2213) and liraglutide (n = 2213) overall cohorts and in 244 patients with HbA 1c results from each treatment group. Mean HbA 1c change from baseline was −1.0% for both groups. At 6 months, mean ± standard deviation adherence was 0.69 ± 0.29 versus 0.64 ± 0.29 (p < 0.001), and discontinuation was 33.2 versus 37.8% (p = 0.002) with albiglutide versus liraglutide, but these were not statistically or clinically different at 12 months. Conclusion: Similar treatment patterns and clinically meaningful reductions in HbA 1c were observed for both treatments in this real-world comparison.

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Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases

Wang

Ping

et al. 2022

JAMA Intern Med

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IMPORTANCE Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been widely recommended for glucose control and cardiovascular risk reduction in patients with type 2 diabetes, and more recently, for weight loss. However, the associations of GLP-1 RAs with gallbladder or biliary diseases are controversial.OBJECTIVE To evaluate the association of GLP-1 RA treatment with gallbladder and biliary diseases and to explore risk factors for these associations.DATA SOURCES MEDLINE/PubMed, EMBASE, Web of Science, and Cochrane Library (inception to June 30, 2021), websites of clinical trial registries (July 10, 2021), and reference lists. There were no language restrictions. STUDY SELECTION Randomized clinical trials (RCTs) comparing the use of GLP-1 RA drugs with placebo or with non−GLP-1 RA drugs in adults.DATA EXTRACTION AND SYNTHESIS Two reviewers independently extracted data according to the PRISMA recommendations and assessed the quality of each study with the Cochrane Collaboration risk-of-bias tool. Pooled relative risks (RRs) were calculated using random or fixed-effects models, as appropriate. The quality of evidence for each outcome was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework. MAIN OUTCOMES AND MEASURESThe primary outcome was the composite of gallbladder or biliary diseases. Secondary outcomes were biliary diseases, biliary cancer, cholecystectomy, cholecystitis, and cholelithiasis. Data analyses were performed from August 5, 2021, to September 3, 2021.RESULTS A total of 76 RCTs involving 103 371 patients (mean [SD] age, 57.8 (6.2) years; 41 868 [40.5%] women) were included. Among all included trials, randomization to GLP-1 RA treatment was associated with increased risks of gallbladder or biliary diseases (RR, 1.37; 95% CI, 1.23-1.52); specifically, cholelithiasis (RR, 1.27; 95% CI, 1.10-1.47), cholecystitis (RR, 1.36; 95% CI, 1.14-1.62), and biliary disease (RR, 1.55; 95% CI, 1.08-2.22). Use of GLP-1 RAs was also associated with increased risk of gallbladder or biliary diseases in trials for weight loss (n = 13; RR, 2.29; 95% CI, 1.64-3.18) and for type 2 diabetes or other diseases (n = 63; RR, 1.27; 95% CI, 1.14-1.43; P <.001 for interaction). Among all included trials, GLP-1 RA use was associated with higher risks of gallbladder or biliary diseases at higher doses (RR, 1.56; 95% CI, 1.36-1.78) compared with lower doses (RR, 0.99; 95% CI, 0.73-1.33; P = .006 for interaction) and with longer duration of use (RR, 1.40; 95% CI, 1.26-1.56) compared with shorter duration (RR, 0.79; 95% CI, 0.48-1.31; P = .03 for interaction).CONCLUSIONS AND RELEVANCE This systematic review and meta-analysis of RCTs found that use of GLP-1 RAs was associated with increased risk of gallbladder or biliary diseases, especially when used at higher doses, for longer durations, and for weight loss.

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Abstract: Albiglutide 30 mg administered once weekly as an add-on to pioglitazone (with or without metformin) provided effective and durable glucose lowering and was generally well tolerated.

Cited by 92 publications

References 17 publications

Emerging New Therapies for the Treatment of Type 2 Diabetes Mellitus: Glucagon-like Peptide-1 Receptor Agonists

Emerging New Therapies for the Treatment of Type 2 Diabetes Mellitus: Glucagon-like Peptide-1 Receptor Agonists

Real-world comparison of treatment patterns and effectiveness of albiglutide and liraglutide

Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases

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