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Murray Stewart – One of the best experts on this subject based on the ideXlab platform.

  • Efficacy and safety of once-weekly GLP-1 receptor agonist Albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise
    Diabetologia, 2015
    Co-Authors: Michael A. Nauck, Murray Stewart, Fred Yang, Rickey R. Reinhardt, Caroline R Perry, Christopher Perkins, Angela Jones-leone, Marc Rendell

    Abstract:

    Aims/hypothesis
    Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated Albiglutide as monotherapy.

  • efficacy and tolerability of Albiglutide versus placebo or pioglitazone over 1 year in people with type 2 diabetes currently taking metformin and glimepiride harmony 5
    Diabetes Obesity and Metabolism, 2015
    Co-Authors: P D Home, Murray Stewart, Fred Yang, Caroline Perry, P Shamanna, M Miller, Molly C Carr

    Abstract:

    Aims
    To investigate the efficacy and tolerability of Albiglutide, a weekly glucagon-like peptide-1 receptor agonist, when added to metformin and glimepiride in a triple therapy regimen in people with type 2 diabetes mellitus.

    Methods
    This was a 156-week, randomized, double-blind, parallel-group, multicentre study. In the present paper we describe the primary results, namely those at 52 weeks. Adult participants (n = 685) were randomly assigned to Albiglutide (30 mg/week), pioglitazone (30 mg/day) or placebo. If needed, blinded uptitration of Albiglutide (to 50 mg/week) and pioglitazone (to 45 mg/day) was allowed. The participant’s current dose of metformin (>1500 mg/day) was maintained throughout. The glimepiride dose (4 mg/day), standardized before randomization, could be decreased if persistent hypoglycaemia occurred.

    Results
    The week 52 model-adjusted difference in change of glycated haemoglobin (primary endpoint) for Albiglutide versus placebo was -0.87 [95% confidence interval (CI) –1.07, –0.68]%-units (p < 0.001), and for Albiglutide versus pioglitazone it was 0.25 (95% CI 0.10, 0.40)%-units; therefore, not non-inferior. In the Albiglutide group only, fasting plasma glucose reduced rapidly in the first 2 weeks. Confirmed hypoglycaemia occurred in 14% of participants on Albiglutide, 25% on pioglitazone and 14% on placebo. The mean (± standard error) weight change was −0.42 (±0.2) kg with Albiglutide, +4.4 (±0.2) kg (p < 0.001) with pioglitazone, and −0.40 (±0.4) kg with placebo and serious adverse events occurred in 6.3, 9.0 and 6.1% of participants in the respective groups. Injection site reactions occurred in 13% of participants on Albiglutide and resulted in treatment discontinuation for four participants (1.4%).

    Conclusions
    Albiglutide, as part of triple therapy, provided effective glucose-lowering and was generally well tolerated.

  • Efficacy and tolerability of Albiglutide versus placebo or pioglitazone over 1 year in people with type 2 diabetes currently taking metformin and glimepiride: HARMONY 5
    Diabetes obesity & metabolism, 2014
    Co-Authors: Philip Home, Murray Stewart, Fred Yang, P Shamanna, M Miller, Caroline R Perry, Molly C Carr

    Abstract:

    Aims
    To investigate the efficacy and tolerability of Albiglutide, a weekly glucagon-like peptide-1 receptor agonist, when added to metformin and glimepiride in a triple therapy regimen in people with type 2 diabetes mellitus.

    Methods
    This was a 156-week, randomized, double-blind, parallel-group, multicentre study. In the present paper we describe the primary results, namely those at 52 weeks. Adult participants (n = 685) were randomly assigned to Albiglutide (30 mg/week), pioglitazone (30 mg/day) or placebo. If needed, blinded uptitration of Albiglutide (to 50 mg/week) and pioglitazone (to 45 mg/day) was allowed. The participant’s current dose of metformin (>1500 mg/day) was maintained throughout. The glimepiride dose (4 mg/day), standardized before randomization, could be decreased if persistent hypoglycaemia occurred.

    Results
    The week 52 model-adjusted difference in change of glycated haemoglobin (primary endpoint) for Albiglutide versus placebo was -0.87 [95% confidence interval (CI) –1.07, –0.68]%-units (p 

Molly C Carr – One of the best experts on this subject based on the ideXlab platform.

  • Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial
    , 2020
    Co-Authors: Julio Rosenstock, Molly C Carr, Antonio Nino, Joseph Soffer, Lois Erskine, Andre Acusta, Jo Dole, Jason Mallory, Philip Home

    Abstract:

    <b>Objective: </b>The principle of replacing prandial insulin
    lispro with a once-weekly GLP-1 receptor agonist (GLP-1RA) in type 2 diabetes inadequately
    controlled on a multiple daily insulin injections regimen was tested with
    Albiglutide.

    <p> </p>

    <p><b>Research Design and Methods</b>: In this treat-to-target study, basal+prandial
    insulin was optimized over 4 weeks before participants were randomized (1:1) to
    Albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50%
    at randomization; subsequently lispro injections were fully discontinued 4 weeks
    later) (n=402), or to continued optimized lispro plus optimized glargine
    (n=412).</p>

    <p> </p>

    <p><b>Results<a>:</a></b> <a>Mean±SD HbA<sub>1c</sub> at baseline, 7.8±0.6% (61±7 mmol/mol) in the Albiglutide+glargine group and 7.7±0.6% (60±7 mmol/mol) in the
    lispro+glargine group, were reduced at week 26 to 6.7±0.8% (49±8 mmol/mol) and 6.6±0.8%
    (48±8 mmol/mol); respectively (LS difference 0.06% [95% CI, −0.05 to 0.17]; noninferiority
    <i>P</i><0.0001)</a>. In the Albiglutide+glargine
    group, 218 participants (54%) replaced all prandial insulin without
    reintroducing lispro up to week 26. Total daily prandial insulin dose was
    similar at baseline but was lower by 62U/day (95% CI −65.9 to −57.8; <i>P</i><0.0001) at week 26 in the
    Albiglutide+glargine group <a></a> and the total number of weekly injections was also
    reduced from 29 to 13 per week. Less severe/documented symptomatic hypoglycemia (57.2% vs. 75.0%) occurred
    in the Albiglutide+glargine group with meaningful weight differences (LS
    mean±SE: −2.0±0.2 vs. +2.4±0.2 kg; <i>P</i><0.0001)
    vs. lispro+glargine. Gastrointestinal adverse events were higher with
    Albiglutide+glargine (26% vs. 13%). </p>

    <p> </p>

    <p><b>Conclusions<a>:</a></b> A
    once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of
    people, substantially reducing the number of prandial insulin injections; glycemic
    control improved, with the added benefits of weight loss and less hypoglycemia
    in the GLP1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify
    basal+prandial insulin treatments and achieve better outcomes in type 2
    diabetes. </p>

  • Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial.
    Diabetes care, 2020
    Co-Authors: Julio Rosenstock, Jason M. Mallory, Molly C Carr, Antonio Nino, Joseph Soffer, Andre Acusta, Lois M. Erskine, Jo F. Dole, Philip Home

    Abstract:

    OBJECTIVE The principle of replacing prandial insulin lispro with a once-weekly glucagon-like peptide 1 receptor agonist (GLP-1RA) for type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with Albiglutide. RESEARCH DESIGN AND METHODS In this treat-to-target study, basal plus prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to Albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently, lispro injections were fully discontinued 4 weeks later) (n = 402) or to continued optimized lispro plus optimized glargine (n = 412). RESULTS Mean ± SD HbA1c at baseline, 7.8 ± 0.6% (61 ± 7 mmol/mol) in the Albiglutide + glargine group and 7.7 ± 0.6% (60 ± 7 mmol/mol) in the lispro + glargine group, was reduced at week 26 to 6.7% ± 0.8% (49 ± 8 mmol/mol) and 6.6 ± 0.8% (48 ± 8 mmol/mol), respectively (least squares [LS] difference 0.06% [95% CI −0.05 to 0.17]; noninferiority P CONCLUSIONS A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP-1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal plus prandial insulin treatments and achieve better outcomes in type 2 diabetes.

  • Impact of a Weekly GLP-1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial
    , 2020
    Co-Authors: Julio Rosenstock, Molly C Carr, Antonio Nino, Joseph Soffer, Lois Erskine, Andre Acusta, Jo Dole, Jason Mallory, Philip Home

    Abstract:

    <b>Objective: </b>The principle of replacing prandial insulin
    lispro with a once-weekly GLP-1 receptor agonist (GLP-1RA) in type 2 diabetes inadequately
    controlled on a multiple daily insulin injections regimen was tested with
    Albiglutide.

    <p> </p>

    <p><b>Research Design and Methods</b>: In this treat-to-target study, basal+prandial
    insulin was optimized over 4 weeks before participants were randomized (1:1) to
    Albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50%
    at randomization; subsequently lispro injections were fully discontinued 4 weeks
    later) (n=402), or to continued optimized lispro plus optimized glargine
    (n=412).</p>

    <p> </p>

    <p><b>Results<a>:</a></b> <a>Mean±SD HbA<sub>1c</sub> at baseline, 7.8±0.6% (61±7 mmol/mol) in the Albiglutide+glargine group and 7.7±0.6% (60±7 mmol/mol) in the
    lispro+glargine group, were reduced at week 26 to 6.7±0.8% (49±8 mmol/mol) and 6.6±0.8%
    (48±8 mmol/mol); respectively (LS difference 0.06% [95% CI, −0.05 to 0.17]; noninferiority
    <i>P</i><0.0001)</a>. In the Albiglutide+glargine
    group, 218 participants (54%) replaced all prandial insulin without
    reintroducing lispro up to week 26. Total daily prandial insulin dose was
    similar at baseline but was lower by 62U/day (95% CI −65.9 to −57.8; <i>P</i><0.0001) at week 26 in the
    Albiglutide+glargine group <a></a> and the total number of weekly injections was also
    reduced from 29 to 13 per week. Less severe/documented symptomatic hypoglycemia (57.2% vs. 75.0%) occurred
    in the Albiglutide+glargine group with meaningful weight differences (LS
    mean±SE: −2.0±0.2 vs. +2.4±0.2 kg; <i>P</i><0.0001)
    vs. lispro+glargine. Gastrointestinal adverse events were higher with
    Albiglutide+glargine (26% vs. 13%). </p>

    <p> </p>

    <p><b>Conclusions<a>:</a></b> A
    once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of
    people, substantially reducing the number of prandial insulin injections; glycemic
    control improved, with the added benefits of weight loss and less hypoglycemia
    in the GLP1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify
    basal+prandial insulin treatments and achieve better outcomes in type 2
    diabetes. </p>

Bo Ahrén – One of the best experts on this subject based on the ideXlab platform.

  • Three-year data from 5 HARMONY phase 3 clinical trials of Albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy
    Diabetes research and clinical practice, 2017
    Co-Authors: Philip Home, Bo Ahrén, Deborah T Cirkel, Molly C Carr, Jane E.b. Reusch, Marc Rendell, Peter N. Weissman, Diane Miller, Philip D. Ambery, Michael A. Nauck

    Abstract:

    Abstract Aims Diabetes therapies that provide durable glycaemic control for people with type 2 diabetes mellitus (T2DM) are needed. We present efficacy results of Albiglutide, a glucagon-like peptide-1 receptor agonist, in people with T2DM over a 3-year period. Methods Five of the 8 HARMONY phase 3 trials, comparing Albiglutide with other therapies or placebo across a spectrum of clinical care, lasted for a preplanned 3 years. Participants with uncontrolled hyperglycaemia who met predetermined criteria could receive rescue medication. The ability to remain on study medication without needing additional rescue was an efficacy measure. Glycaemic measures and body weight were analysed in 2 populations: those who remained rescue-free and all participants. Results Participants ( n  = 3132) were randomised to Albiglutide or comparator. A greater proportion of participants who received Albiglutide remained rescue-free (55–71%) compared with placebo (35–51%; p p  = 0.002). The proportion of rescue-free participants with Albiglutide did not differ from glimepiride or insulin glargine, was higher than with sitagliptin ( p  = 0.013), and lower than with pioglitazone ( p  = 0.045). At 3 years, Albiglutide was associated with clinically significant reductions in hyperglycaemia (eg, rescue-free participants: HbA1c −0.52% [SE0.11] to −0.98% [0.12]; −5.7 mmol/mol [1.2] to −10.7 mmol/mol [1.3] and all participants: HbA1c −0.29% [0.11] to − 0.92% [0.13]; −3.2 mmol/mol [1.2] to −10.1 mmol/mol [1.4]). Albiglutide was also associated with modest reductions in body weight vs pioglitazone, glimepiride, and insulin glargine, which were associated with weight gain. Conclusion These 3-year efficacy data support long-term use of Albiglutide in the management of people with T2DM. ClinicalTrials.gov NCT00849056 , NCT00849017 , NCT00838903 , NCT00838916 , NCT00839527 .

  • Once weekly glucagon-like peptide-1 receptor agonist Albiglutide vs. prandial insulin added to basal insulin in patients with type 2 diabetes mellitus: Results over 52 weeks
    Journal of diabetes and its complications, 2017
    Co-Authors: Lawrence A. Leiter, Susan L Johnson, Diane Miller, Jorge Luiz Gross, Francis C.c. Chow, Bo Ahrén

    Abstract:

    We have previously reported that once-weekly Albiglutide was noninferior to thrice-daily lispro for glycemic lowering, with decreased weight and risk of hypoglycemia, in patients inadequately controlled on basal insulin over 26 weeks. Findings after 52 weeks reveal similar responses to Albiglutide as an add-on to insulin glargine.

  • Albiglutide for the treatment of type 2 diabetes mellitus: An integrated safety analysis of the HARMONY phase 3 trials
    Diabetes research and clinical practice, 2017
    Co-Authors: Bo Ahrén, Jason M. Mallory, Timothy Wilson, Molly C Carr, Karen Murphy, Christopher Perkins, Marc Rendell, Susan L Johnson

    Abstract:

    Aims Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) stimulate the incretin system and lower glycaemic parameters in type 2 diabetes mellitus (T2DM). This analysis of clinical studies of up to 3 years evaluated the safety of Albiglutide, a GLP-1 RA, in people with T2DM. Methods Integrated safety analysis included seven phase-3 T2DM studies of Albiglutide compared with placebo and/or active comparators (a dipeptidyl peptidase-4 inhibitor, GLP-1 RA, insulin, sulphonylurea, and thiazolidinedione). Results Studies of 32 months (HARMONY 7), 1 year (HARMONY 6), and 3 years (HARMONY 1–5), reported similar rates of adverse events (AEs) (84.8%, 82.3%), and serious AEs (13.1%, 12.9%) between Albiglutide and all comparators, respectively. AEs that did not differ between the groups included symptomatic or severe hypoglycaemia as well as nausea (12.0%, 11.3%) and vomiting (5.3%, 4.7%) for Albiglutide and all comparators, respectively. According to the Medical Dictionary for Regulatory Activities preferred terms, only diarrhoea (13.7%, 9.9%), injection-site reaction (9.0%, 2.0%), and peripheral oedema (4.5%, 6.8%) had at least 2% difference between the Albiglutide and all-comparator groups. In a similar integrated analysis, pancreatitis occurred more often with Albiglutide (0.3%, 0.1%). Renal and cardiac function did not differ between the two groups. Conclusions In an integrated analysis of seven phase 3 clinical trials, Albiglutide-treated patients experienced frequencies of AEs (including cardiovascular and renal) similar to the all-comparators group treated with other T2DM medications or placebo. Albiglutide treatment was associated with higher rates of diarrhoea and injection-site reactions, but not increased nausea and vomiting, versus all comparators.