Tags

Type your tag names separated by a space and hit enter

Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world.
BMJ Open Diabetes Res Care. 2019; 7(1):e000581.BO

Abstract

Objective

To assess the efficacy and safety of iGlarLixi (titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide) in patients with type 2 diabetes (T2D) living in North America (NA; USA and Canada) compared with the rest of the world (RoW).

Research design and methods

Post hoc analysis included patient-level data from 509 sites/centers across two phase III trials: LixiLan-O (NCT02058147; insulin-naive patients; NA, n=371; RoW, n=796) and LixiLan-L (NCT02058160; inadequately controlled patients on basal insulin; NA, n=196; RoW, n=535). Efficacy outcomes were: change from baseline to Week 30 in glycated hemoglobin (HbA1c), postprandial glucose (PPG), PPG excursions, fasting plasma glucose (FPG) and body weight; proportion of patients achieving HbA1c <42 mmol/mol (<7.0%); proportion of patients achieving composite endpoint: HbA1c <42 mmol/mol (<7.0%), no weight gain or symptomatic hypoglycemia (blood glucose ≤3.9 mmol/L (≤70 mg/dL)). Safety endpoints included incidence of documented symptomatic hypoglycemia and gastrointestinal (GI) adverse events.

Results

Significantly larger reductions (p≤0.003) in HbA1c from baseline to Week 30 were achieved with iGlarLixi, compared with iGlar or lixisenatide, in NA and RoW patients in LixiLan-O (iGlarLixi vs iGlar: -0.31 and -0.29, respectively; iGlarLixi vs lixisenatide: -0.84 and -0.69, respectively) and in LixiLan-L (iGlarLixi vs iGlar: -0.5 and -0.51, respectively). Documented symptomatic hypoglycemia was similar between NA and RoW patients. iGlarLixi resulted in significant weight benefits versus iGlar (change from baseline -1.58 and -1.29 kg for NA and RoW patients, respectively; p<0.001). GI adverse events were similar for iGlarLixi and iGlar, but significantly higher for lixisenatide.

Conclusions

iGlarLixi improved glycemic parameters versus iGlar or lixisenatide alone in both NA and RoW patients, with beneficial weight effects versus iGlar. iGlarLixi treatment responses, hypoglycemia risk and GI adverse events in NA patients were comparable with patients in the RoW.

Trial registry

Clinicaltrials.gov NCT02058147 and NCT02058160.

Authors+Show Affiliations

Division of Diabetes and Endocrinology, Scripps Whittier Diabetes Institute, San Diego, California, USA.LMC Diabetes and Endocrinology, Brampton, Ontario, Canada. Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto, Ontario, Canada.Sanofi US, Bridgewater, New Jersey, USA.Sanofi Canada, Laval, Quebec, Canada.Sanofi US, Bridgewater, New Jersey, USA.Eastern Virginia Medical School, Norfolk, Virginia, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31114694

Citation

Dailey, George, et al. "Post Hoc Efficacy and Safety Analysis of Insulin Glargine/lixisenatide Fixed- Ratio Combination in North American Patients Compared With the Rest of World." BMJ Open Diabetes Research & Care, vol. 7, no. 1, 2019, pp. e000581.
Dailey G, Bajaj HS, Dex T, et al. Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world. BMJ Open Diabetes Res Care. 2019;7(1):e000581.
Dailey, G., Bajaj, H. S., Dex, T., Groleau, M., Stager, W., & Vinik, A. (2019). Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world. BMJ Open Diabetes Research & Care, 7(1), e000581. https://doi.org/10.1136/bmjdrc-2018-000581
Dailey G, et al. Post Hoc Efficacy and Safety Analysis of Insulin Glargine/lixisenatide Fixed- Ratio Combination in North American Patients Compared With the Rest of World. BMJ Open Diabetes Res Care. 2019;7(1):e000581. PubMed PMID: 31114694.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world. AU - Dailey,George, AU - Bajaj,Harpreet S, AU - Dex,Terry, AU - Groleau,Melanie, AU - Stager,William, AU - Vinik,Aaron, Y1 - 2019/03/21/ PY - 2018/07/18/received PY - 2018/12/07/revised PY - 2018/12/09/accepted PY - 2019/5/23/entrez PY - 2019/5/23/pubmed PY - 2019/5/23/medline KW - North America KW - efficacy KW - iGlarLixi KW - safety SP - e000581 EP - e000581 JF - BMJ open diabetes research & care JO - BMJ Open Diabetes Res Care VL - 7 IS - 1 N2 - Objective: To assess the efficacy and safety of iGlarLixi (titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide) in patients with type 2 diabetes (T2D) living in North America (NA; USA and Canada) compared with the rest of the world (RoW). Research design and methods: Post hoc analysis included patient-level data from 509 sites/centers across two phase III trials: LixiLan-O (NCT02058147; insulin-naive patients; NA, n=371; RoW, n=796) and LixiLan-L (NCT02058160; inadequately controlled patients on basal insulin; NA, n=196; RoW, n=535). Efficacy outcomes were: change from baseline to Week 30 in glycated hemoglobin (HbA1c), postprandial glucose (PPG), PPG excursions, fasting plasma glucose (FPG) and body weight; proportion of patients achieving HbA1c <42 mmol/mol (<7.0%); proportion of patients achieving composite endpoint: HbA1c <42 mmol/mol (<7.0%), no weight gain or symptomatic hypoglycemia (blood glucose ≤3.9 mmol/L (≤70 mg/dL)). Safety endpoints included incidence of documented symptomatic hypoglycemia and gastrointestinal (GI) adverse events. Results: Significantly larger reductions (p≤0.003) in HbA1c from baseline to Week 30 were achieved with iGlarLixi, compared with iGlar or lixisenatide, in NA and RoW patients in LixiLan-O (iGlarLixi vs iGlar: -0.31 and -0.29, respectively; iGlarLixi vs lixisenatide: -0.84 and -0.69, respectively) and in LixiLan-L (iGlarLixi vs iGlar: -0.5 and -0.51, respectively). Documented symptomatic hypoglycemia was similar between NA and RoW patients. iGlarLixi resulted in significant weight benefits versus iGlar (change from baseline -1.58 and -1.29 kg for NA and RoW patients, respectively; p<0.001). GI adverse events were similar for iGlarLixi and iGlar, but significantly higher for lixisenatide. Conclusions: iGlarLixi improved glycemic parameters versus iGlar or lixisenatide alone in both NA and RoW patients, with beneficial weight effects versus iGlar. iGlarLixi treatment responses, hypoglycemia risk and GI adverse events in NA patients were comparable with patients in the RoW. Trial registry: Clinicaltrials.gov NCT02058147 and NCT02058160. SN - 2052-4897 UR - https://www.unboundmedicine.com/medline/citation/31114694/Post_hoc_efficacy_and_safety_analysis_of_insulin_glargine/lixisenatide_fixed__ratio_combination_in_North_American_patients_compared_with_the_rest_of_world_ L2 - https://drc.bmj.com/cgi/pmidlookup?view=long&amp;pmid=31114694 DB - PRIME DP - Unbound Medicine ER -