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Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L).
Diabetes Care. 2013 Sep; 36(9):2489-96.DC

Abstract

OBJECTIVE

To examine the efficacy and safety of adding the once-daily glucagon-like peptide-1 receptor agonist (GLP-1RA) lixisenatide to established basal insulin therapy alone or together with metformin, in people with type 2 diabetes and elevated glycated hemoglobin (HbA1c).

RESEARCH DESIGN AND METHODS

We conducted a double-blind, parallel-group, placebo-controlled trial. Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks. Basal insulin dosage was unchanged except to limit hypoglycemia. HbA1c reduction from baseline was the primary end point.

RESULTS

Mean duration of diabetes was 12.5 years, duration of insulin use was 3.1 years, insulin dosage was 55 units/day, and baseline HbA1c was 8.4%. With lixisenatide, the placebo-corrected change of HbA1c from baseline was -0.4% (95% CI -0.6 to -0.2; P = 0.0002), and mean HbA1c at end point was 7.8%. HbA1c <7.0% (53 mmol/mol) was attained by more lixisenatide (28%) than placebo (12%; P < 0.0001) participants. Lixisenatide reduced plasma glucose levels after a standardized breakfast (placebo-corrected reduction, -3.8 mmol/L; P < 0.0001); seven-point glucose profiles showed a reduction persisting through the day. Reductions in body weight (placebo corrected, -1.3 kg; P < 0.0001) and insulin dosage (-3.7 units/day; P = 0.012) were greater with lixisenatide. Main adverse events (AEs) with lixisenatide were gastrointestinal. Symptomatic hypoglycemia was 28% for lixisenatide and 22% for placebo; 4 of 328 subjects (1.2%) had severe hypoglycemia with lixisenatide vs. 0 of 167 with placebo.

CONCLUSIONS

By improving HbA1c and postprandial hyperglycemia without weight gain in type 2 diabetes with inadequate glycemic control despite stable basal insulin, lixisenatide may provide an alternative to rapid-acting insulin or other treatment options.

Authors+Show Affiliations

Oregon Health & Science University, Portland, Oregon, USA. riddlem@ohsu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23628617

Citation

Riddle, Matthew C., et al. "Adding Once-daily Lixisenatide for Type 2 Diabetes Inadequately Controlled By Established Basal Insulin: a 24-week, Randomized, Placebo-controlled Comparison (GetGoal-L)." Diabetes Care, vol. 36, no. 9, 2013, pp. 2489-96.
Riddle MC, Aronson R, Home P, et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013;36(9):2489-96.
Riddle, M. C., Aronson, R., Home, P., Marre, M., Niemoeller, E., Miossec, P., Ping, L., Ye, J., & Rosenstock, J. (2013). Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care, 36(9), 2489-96. https://doi.org/10.2337/dc12-2454
Riddle MC, et al. Adding Once-daily Lixisenatide for Type 2 Diabetes Inadequately Controlled By Established Basal Insulin: a 24-week, Randomized, Placebo-controlled Comparison (GetGoal-L). Diabetes Care. 2013;36(9):2489-96. PubMed PMID: 23628617.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). AU - Riddle,Matthew C, AU - Aronson,Ronnie, AU - Home,Philip, AU - Marre,Michel, AU - Niemoeller,Elisabeth, AU - Miossec,Patrick, AU - Ping,Lin, AU - Ye,Jenny, AU - Rosenstock,Julio, Y1 - 2013/04/29/ PY - 2013/5/1/entrez PY - 2013/5/1/pubmed PY - 2014/4/22/medline SP - 2489 EP - 96 JF - Diabetes care JO - Diabetes Care VL - 36 IS - 9 N2 - OBJECTIVE: To examine the efficacy and safety of adding the once-daily glucagon-like peptide-1 receptor agonist (GLP-1RA) lixisenatide to established basal insulin therapy alone or together with metformin, in people with type 2 diabetes and elevated glycated hemoglobin (HbA1c). RESEARCH DESIGN AND METHODS: We conducted a double-blind, parallel-group, placebo-controlled trial. Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 μg or placebo for 24 weeks. Basal insulin dosage was unchanged except to limit hypoglycemia. HbA1c reduction from baseline was the primary end point. RESULTS: Mean duration of diabetes was 12.5 years, duration of insulin use was 3.1 years, insulin dosage was 55 units/day, and baseline HbA1c was 8.4%. With lixisenatide, the placebo-corrected change of HbA1c from baseline was -0.4% (95% CI -0.6 to -0.2; P = 0.0002), and mean HbA1c at end point was 7.8%. HbA1c <7.0% (53 mmol/mol) was attained by more lixisenatide (28%) than placebo (12%; P < 0.0001) participants. Lixisenatide reduced plasma glucose levels after a standardized breakfast (placebo-corrected reduction, -3.8 mmol/L; P < 0.0001); seven-point glucose profiles showed a reduction persisting through the day. Reductions in body weight (placebo corrected, -1.3 kg; P < 0.0001) and insulin dosage (-3.7 units/day; P = 0.012) were greater with lixisenatide. Main adverse events (AEs) with lixisenatide were gastrointestinal. Symptomatic hypoglycemia was 28% for lixisenatide and 22% for placebo; 4 of 328 subjects (1.2%) had severe hypoglycemia with lixisenatide vs. 0 of 167 with placebo. CONCLUSIONS: By improving HbA1c and postprandial hyperglycemia without weight gain in type 2 diabetes with inadequate glycemic control despite stable basal insulin, lixisenatide may provide an alternative to rapid-acting insulin or other treatment options. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/23628617/Adding_once_daily_lixisenatide_for_type_2_diabetes_inadequately_controlled_by_established_basal_insulin:_a_24_week_randomized_placebo_controlled_comparison__GetGoal_L__ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=23628617 DB - PRIME DP - Unbound Medicine ER -