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Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1).
Diabet Med. 2014 Feb; 31(2):176-84.DM

Abstract

AIMS

To assess the efficacy and safety of one- and two-step dose-increase regimens of lixisenatide once daily in participants with Type 2 diabetes mellitus insufficiently controlled with metformin.

METHODS

This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin. Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period. Primary outcome was HbA1c reduction at week 24.

RESULTS

Lixisenatide one-/two-step once daily significantly improved HbA1c at week 24 compared with placebo (P < 0.0001) and allowed more participants to achieve HbA1c < 53 mmol/mol (< 7.0%) (P ≤ 0.0005). Improvements were observed in fasting plasma glucose (-0.5/-0.6 vs. +0.1 mmol/l; P < 0.001) and body weight (-2.6/-2.7 vs. -1.6 kg; P < 0.005). At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one-/two-step/placebo, respectively--nausea and vomiting being reported most frequently. Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one-/two-step lixisenatide and 0.6% with placebo, with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable double-blind extension period of at least 52 weeks.

CONCLUSIONS

Lixisenatide one- or two-step dose-increase regimens significantly improved glycaemic control and decreased body weight over 24 weeks and during a long-term extension period without increasing hypoglycaemia. The study confirmed that tolerability in the one-step group was at least similar to the two-step dose increase, with nausea/vomiting and hypoglycaemia frequency being lower in the one-step regimen.

Authors+Show Affiliations

University of Perugia, Perugia, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24117597

Citation

Bolli, G B., et al. "Efficacy and Safety of Lixisenatide once Daily Vs. Placebo in People With Type 2 Diabetes Insufficiently Controlled On Metformin (GetGoal-F1)." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 31, no. 2, 2014, pp. 176-84.
Bolli GB, Munteanu M, Dotsenko S, et al. Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1). Diabet Med. 2014;31(2):176-84.
Bolli, G. B., Munteanu, M., Dotsenko, S., Niemoeller, E., Boka, G., Wu, Y., & Hanefeld, M. (2014). Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1). Diabetic Medicine : a Journal of the British Diabetic Association, 31(2), 176-84. https://doi.org/10.1111/dme.12328
Bolli GB, et al. Efficacy and Safety of Lixisenatide once Daily Vs. Placebo in People With Type 2 Diabetes Insufficiently Controlled On Metformin (GetGoal-F1). Diabet Med. 2014;31(2):176-84. PubMed PMID: 24117597.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1). AU - Bolli,G B, AU - Munteanu,M, AU - Dotsenko,S, AU - Niemoeller,E, AU - Boka,G, AU - Wu,Y, AU - Hanefeld,M, Y1 - 2013/10/24/ PY - 2013/05/31/received PY - 2013/07/31/revised PY - 2013/09/19/accepted PY - 2013/10/15/entrez PY - 2013/10/15/pubmed PY - 2015/4/17/medline SP - 176 EP - 84 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet Med VL - 31 IS - 2 N2 - AIMS: To assess the efficacy and safety of one- and two-step dose-increase regimens of lixisenatide once daily in participants with Type 2 diabetes mellitus insufficiently controlled with metformin. METHODS: This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin. Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period. Primary outcome was HbA1c reduction at week 24. RESULTS: Lixisenatide one-/two-step once daily significantly improved HbA1c at week 24 compared with placebo (P < 0.0001) and allowed more participants to achieve HbA1c < 53 mmol/mol (< 7.0%) (P ≤ 0.0005). Improvements were observed in fasting plasma glucose (-0.5/-0.6 vs. +0.1 mmol/l; P < 0.001) and body weight (-2.6/-2.7 vs. -1.6 kg; P < 0.005). At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one-/two-step/placebo, respectively--nausea and vomiting being reported most frequently. Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one-/two-step lixisenatide and 0.6% with placebo, with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable double-blind extension period of at least 52 weeks. CONCLUSIONS: Lixisenatide one- or two-step dose-increase regimens significantly improved glycaemic control and decreased body weight over 24 weeks and during a long-term extension period without increasing hypoglycaemia. The study confirmed that tolerability in the one-step group was at least similar to the two-step dose increase, with nausea/vomiting and hypoglycaemia frequency being lower in the one-step regimen. SN - 1464-5491 UR - https://www.unboundmedicine.com/medline/citation/24117597/Efficacy_and_safety_of_lixisenatide_once_daily_vs__placebo_in_people_with_Type_2_diabetes_insufficiently_controlled_on_metformin__GetGoal_F1__ L2 - https://doi.org/10.1111/dme.12328 DB - PRIME DP - Unbound Medicine ER -