scholarly journals Efficacy and safety of liraglutide, a once‐daily human glucagon‐like peptide‐1 analogue, in L atino/ H ispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials

2016 ◽  
Vol 18 (7) ◽  
pp. 725-728 ◽  
Author(s):  
J. A. Davidson ◽  
D. D. Ørsted ◽  
C. Campos
Keyword(s):  
Type 2 Diabetes ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Once Daily ◽  
Post Hoc Analysis ◽  
Phase Iii Trials ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1 ◽  
Post Hoc

scholarly journals The effect of liraglutide and sitagliptin on oxidative stress in persons with type 2 diabetes

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Suvanjaa Sivalingam ◽  
Emil List Larsen ◽  
Daniel H. van Raalte ◽  
Marcel H. A. Muskiet ◽  
Mark M. Smits ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Type 2 Diabetes ◽  
Nucleic Acid ◽  
Urinary Excretion ◽  
Post Hoc Analysis ◽  
Significant Difference ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1 ◽  
Post Hoc

AbstractGlucagon-like peptide 1 receptor agonists have shown cardioprotective effects which have been suggested to be mediated through inhibition of oxidative stress. We investigated the effect of treatment with a glucagon-like peptide 1 receptor agonist (liraglutide) on oxidative stress measured as urinary nucleic acid oxidation in persons with type 2 diabetes. Post-hoc analysis of two independent, randomised, placebo-controlled and double-blinded clinical trials. In a cross-over study where persons with type 2 diabetes and microalbuminuria (LIRALBU, n = 32) received liraglutide (1.8 mg/day) or placebo for 12 weeks in random order, separated by 4 weeks of wash-out. In a parallel-grouped study where obese persons with type 2 diabetes (SAFEGUARD, n = 56) received liraglutide (1.8 mg/day), sitagliptin (100 mg/day) or placebo for 12 weeks. Endpoints were changes in the urinary markers of DNA oxidation (8-oxo-7,8-dihydro-2′-deoxyguanosine (8-oxodG)) and RNA oxidation [8-oxo-7,8-dihydroguanosine (8-oxoGuo)]. In LIRALBU, we observed no significant differences between treatment periods in urinary excretion of 8-oxodG [0.028 (standard error (SE): 0.17] nmol/mmol creatinine, p = 0.87) or of 8-oxoGuo [0.12 (0.12) nmol/mmol creatinine, p = 0.31]. In SAFEGUARD, excretion of 8-oxodG was not changed in the liraglutide group [2.8 (− 8.51; 15.49) %, p = 0.62] but a significant decline was demonstrated in the placebo group [12.6 (− 21.3; 3.1) %, p = 0.02], resulting in a relative increase in the liraglutide group compared to placebo (0.16 nmol/mmol creatinine, SE 0.07, p = 0.02). Treatment with sitagliptin compared to placebo demonstrated no significant difference (0.07 (0.07) nmol/mmol creatinine, p = 0.34). Nor were any significant differences for urinary excretion of 8-oxoGuo liraglutide vs placebo [0.09 (SE: 0.07) nmol/mmol creatinine, p = 0.19] or sitagliptin vs placebo [0.07 (SE: 0.07) nmol/mmol creatinine, p = 0.35] observed. This post-hoc analysis could not demonstrate a beneficial effect of 12 weeks of treatment with liraglutide or sitagliptin on oxidatively generated modifications of nucleic acid in persons with type 2 diabetes.

scholarly journals Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study

2021 ◽  
Author(s):  
Lawrence Blonde ◽  
Julio Rosenstock ◽  
Juan Frias ◽  
Andreas L. Birkenfeld ◽  
Elisabeth Niemoeller ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Fixed Ratio ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1 ◽  
Design And Methods ◽  
Extension Period

<b>Objective</b> <p><a>In the LixiLan-G trial, switching to iGlarLixi, a once-daily titratable fixed-ratio combination of insulin glargine </a>100 units/mL and the glucagon-like peptide-1 receptor agonist (GLP-1 RA) lixisenatide, improved glucose control in type 2 diabetes (T2D) uncontrolled with GLP-1 RAs over 26 weeks versus continuing prior GLP-1 RA. A prespecified, 26-week, single-arm extension of LixiLan-G aimed to determine the durability of iGlarLixi efficacy and safety over 52 weeks. </p> <p><b>Research Design and Methods</b></p> <p>Participants with T2D uncontrolled by GLP-1 RAs (HbA<sub>1c</sub> 7–9 % [53–75 mmol/mol]) were initially randomized to switch to iGlarLixi or continue prior GLP-1 RA. Those randomized to iGlarLixi who completed the 26-week primary endpoint period could continue iGlarLixi open-label treatment over a 26-week extension to assess durability of efficacy and safety.</p> <p><b>Results</b></p> <p>Glycemic control achieved with iGlarLixi at week 26 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol]) was maintained at week 52 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol]; mean ± standard deviation change from baseline at week 52: −1.0 ± 0.9 % [11 ± 10 mmol/mol]). Proportions of participants reaching HbA<sub>1c</sub> <7 % (53 mmol/mol) with iGlarLixi were similar at week 26 (62%) and 52 (64%), as were those reaching this target without documented symptomatic (<3.0 mmol/L) hypoglycemia (57% and 58%). Safety of iGlarLixi was similar at weeks 26 and 52, with low rates of documented symptomatic hypoglycemia and gastrointestinal events.</p> <p><b>Conclusions</b></p> The efficacy and safety of iGlarLixi at the end of the 26-week randomized treatment period was maintained over the 26-week extension period in the LixiLan-G trial.

scholarly journals Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials

2019 ◽  
Vol 105 (2) ◽  
pp. 543-556 ◽  
Author(s):  
Cyrus DeSouza ◽  
Bertrand Cariou ◽  
Satish Garg ◽  
Nanna Lausvig ◽  
Andrea Navarria ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Race And Ethnicity ◽  
Efficacy And Safety ◽  
Post Hoc Analysis ◽  
Percentage Points ◽  
Treatment Responses ◽  
Glucagon Like Peptide 1 ◽  
Post Hoc

Abstract Context Variations in the prevalence and etiology of type 2 diabetes (T2D) across race and ethnicity may affect treatment responses. Semaglutide is a glucagon-like peptide-1 analog approved for once-weekly, subcutaneous treatment of T2D. Objective To compare semaglutide efficacy and safety in race and ethnicity subgroups across the SUSTAIN trials. Design Post hoc analysis of data from phase 3 randomized SUSTAIN 1–5 and 7 (pooled), and SUSTAIN 6 trials. Participants 3074 subjects (SUSTAIN 1–5 and 7) and 1648 subjects (SUSTAIN 6). Interventions Semaglutide 0.5 or 1.0 mg, placebo, or active comparator (sitagliptin 100 mg, exenatide extended release 2.0 mg, insulin glargine 100IU/ml and dulaglutide 0.75 or 1.5 mg). Main Outcome Measures Change in hemoglobin A1C (HbA1c) and body weight from baseline to weeks 30, 40 and 104, and other efficacy and safety endpoints. Results HbA1c was reduced from baseline by 1.0 to 1.5 percentage points and 1.3 to 2.0 percentage points, and body weight was reduced by 2.3 to 4.7 kg and 3.6 to 6.1 kg with semaglutide 0.5 and 1.0 mg, respectively, across race and ethnicity subgroups. Minor changes in blood pressure and lipid profiles were observed. Adverse events (AEs) were reported in similar proportions of subjects across trials. More Asian versus other race subgroups discontinued treatment prematurely due to AEs. The most commonly reported AEs were gastrointestinal disorders. Conclusions In this SUSTAIN trials post hoc analysis, semaglutide was associated with consistent and clinically relevant reductions in HbA1c and body weight in subjects with T2D, with minor variations in efficacy and safety outcomes associated with race or ethnicity.

Liraglutide: A Once-Daily Incretin Mimetic for the Treatment of Type 2 Diabetes Mellitus

2009 ◽  
Vol 43 (9) ◽  
pp. 1433-1444 ◽  
Author(s):  
Joshua J Neumiller ◽  
R Keith Campbell
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Body Weight ◽  
Efficacy And Safety ◽  
Β Cell ◽  
Once Daily ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1

Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of liraglutide, a glucagon-like peptide 1 (GLP-1) analog for the treatment of type 2 diabetes mellitus. Data Sources: A MEDLINE search (1966–May 2009) was conducted for English-language articles using the terms glucagon-like peptide 1, incretin mimetic, NN2211, and liraglutide. Abstracts presented at the American Diabetes Association and European Association for the Study of Diabetes annual meetings in 2006, 2007, and 2008 were also searched for relevant data. Study Selection and Data Extraction: Articles pertinent to the pharmacology, pharmacokinetics, efficacy, and safety of liraglutide were reviewed. Data Synthesis: Liraglutide is a GLP-1 analog with pharmacokinetic properties suitable for once-daily administration. Clinical trial data from large, controlled studies demonstrate the effectiveness of liraglutide in terms of hemoglobin A1c (A1C) reduction, reductions in body weight, and the drug's low risk for hypoglycemic events when used as monotherapy. Data also support benefits of liraglutide therapy on β-cell responsiveness to glucose, with animal and in vitro data indicating potential benefits in β-cell mass and neogenesis with liraglutide treatment. Liraglutide has been studied as monotherapy and in combination with metformin, glimepiride, and rosiglitazone for the treatment of type 2 diabetes. Additionally, comparative data with insulin glargine and exenatide therapy are available from Phase 3 trials providing practitioners valuable clinical data on which to base clinical decision making. Overall, liraglutide is well tolerated with dose-dependent nausea, vomiting, and diarrhea being the most commonly reported adverse events in clinical trials. Conclusions: Once-daily administration may provide a therapeutic advantage for liraglutide over twice-daily exenatide, with similar improvements in A1C and body weight observed when liraglutide was compared with exenatide. The glucose-dependent mechanism of insulin release with GLP-1 agonist therapy holds potential clinical significance in the management of postprandial hyperglycemic excursions, with minimal risk of hypoglycemia.

scholarly journals Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study

2021 ◽  
Author(s):  
Lawrence Blonde ◽  
Julio Rosenstock ◽  
Juan Frias ◽  
Andreas L. Birkenfeld ◽  
Elisabeth Niemoeller ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Fixed Ratio ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1 ◽  
Design And Methods ◽  
Extension Period

<b>Objective</b> <p><a>In the LixiLan-G trial, switching to iGlarLixi, a once-daily titratable fixed-ratio combination of insulin glargine </a>100 units/mL and the glucagon-like peptide-1 receptor agonist (GLP-1 RA) lixisenatide, improved glucose control in type 2 diabetes (T2D) uncontrolled with GLP-1 RAs over 26 weeks versus continuing prior GLP-1 RA. A prespecified, 26-week, single-arm extension of LixiLan-G aimed to determine the durability of iGlarLixi efficacy and safety over 52 weeks. </p> <p><b>Research Design and Methods</b></p> <p>Participants with T2D uncontrolled by GLP-1 RAs (HbA<sub>1c</sub> 7–9 % [53–75 mmol/mol]) were initially randomized to switch to iGlarLixi or continue prior GLP-1 RA. Those randomized to iGlarLixi who completed the 26-week primary endpoint period could continue iGlarLixi open-label treatment over a 26-week extension to assess durability of efficacy and safety.</p> <p><b>Results</b></p> <p>Glycemic control achieved with iGlarLixi at week 26 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol]) was maintained at week 52 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol]; mean ± standard deviation change from baseline at week 52: −1.0 ± 0.9 % [11 ± 10 mmol/mol]). Proportions of participants reaching HbA<sub>1c</sub> <7 % (53 mmol/mol) with iGlarLixi were similar at week 26 (62%) and 52 (64%), as were those reaching this target without documented symptomatic (<3.0 mmol/L) hypoglycemia (57% and 58%). Safety of iGlarLixi was similar at weeks 26 and 52, with low rates of documented symptomatic hypoglycemia and gastrointestinal events.</p> <p><b>Conclusions</b></p> The efficacy and safety of iGlarLixi at the end of the 26-week randomized treatment period was maintained over the 26-week extension period in the LixiLan-G trial.

scholarly journals Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study

2021 ◽  
Author(s):  
Lawrence Blonde ◽  
Julio Rosenstock ◽  
Juan Frias ◽  
Andreas L. Birkenfeld ◽  
Elisabeth Niemoeller ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Fixed Ratio ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1 ◽  
Design And Methods ◽  
Extension Period

<b>Objective</b> <p><a>In the LixiLan-G trial, switching to iGlarLixi, a once-daily titratable fixed-ratio combination of insulin glargine </a>100 units/mL and the glucagon-like peptide-1 receptor agonist (GLP-1 RA) lixisenatide, improved glucose control in type 2 diabetes (T2D) uncontrolled with GLP-1 RAs over 26 weeks versus continuing prior GLP-1 RA. A prespecified, 26-week, single-arm extension of LixiLan-G aimed to determine the durability of iGlarLixi efficacy and safety over 52 weeks. </p> <p><b>Research Design and Methods</b></p> <p>Participants with T2D uncontrolled by GLP-1 RAs (HbA<sub>1c</sub> 7–9 % [53–75 mmol/mol]) were initially randomized to switch to iGlarLixi or continue prior GLP-1 RA. Those randomized to iGlarLixi who completed the 26-week primary endpoint period could continue iGlarLixi open-label treatment over a 26-week extension to assess durability of efficacy and safety.</p> <p><b>Results</b></p> <p>Glycemic control achieved with iGlarLixi at week 26 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol]) was maintained at week 52 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol]; mean ± standard deviation change from baseline at week 52: −1.0 ± 0.9 % [11 ± 10 mmol/mol]). Proportions of participants reaching HbA<sub>1c</sub> <7 % (53 mmol/mol) with iGlarLixi were similar at week 26 (62%) and 52 (64%), as were those reaching this target without documented symptomatic (<3.0 mmol/L) hypoglycemia (57% and 58%). Safety of iGlarLixi was similar at weeks 26 and 52, with low rates of documented symptomatic hypoglycemia and gastrointestinal events.</p> <p><b>Conclusions</b></p> The efficacy and safety of iGlarLixi at the end of the 26-week randomized treatment period was maintained over the 26-week extension period in the LixiLan-G trial.

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