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Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).
Diabetes Obes Metab. 2013 Nov; 15(11):1000-7.DO

Abstract

AIMS

To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.

METHODS

This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period. Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) at week 24.

RESULTS

In total, 484 patients were randomized: 323 to lixisenatide; 161 to placebo. After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (-0.84 mmol/l vs. placebo; p < 0.0001). There was a small decrease in body weight with lixisenatide once daily and a small increase with placebo, with no statistically significant difference between the two groups. Overall, lixisenatide once daily was well tolerated, with a similar proportion of treatment-emergent adverse events (TEAEs) and serious TEAEs between groups (lixisenatide: 72.4% and 2.5%; placebo: 72.7% and 1.9%). Symptomatic hypoglycaemia rates were also relatively low in both groups (lixisenatide 3.4% and placebo 1.2%), with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable extension period.

CONCLUSIONS

Lixisenatide once daily significantly improved glycaemic control with a low risk of hypoglycaemia, and was well tolerated over 24 weeks and during the long-term, double-blind extension period in patients with T2DM insufficiently controlled on pioglitazone ± metformin.

Authors+Show Affiliations

Department of Endocrinology and Diabetes, HUS, Strasbourg, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23627775

Citation

Pinget, M, et al. "Efficacy and Safety of Lixisenatide once Daily Versus Placebo in Type 2 Diabetes Insufficiently Controlled On Pioglitazone (GetGoal-P)." Diabetes, Obesity & Metabolism, vol. 15, no. 11, 2013, pp. 1000-7.
Pinget M, Goldenberg R, Niemoeller E, et al. Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013;15(11):1000-7.
Pinget, M., Goldenberg, R., Niemoeller, E., Muehlen-Bartmer, I., Guo, H., & Aronson, R. (2013). Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes, Obesity & Metabolism, 15(11), 1000-7. https://doi.org/10.1111/dom.12121
Pinget M, et al. Efficacy and Safety of Lixisenatide once Daily Versus Placebo in Type 2 Diabetes Insufficiently Controlled On Pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013;15(11):1000-7. PubMed PMID: 23627775.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). AU - Pinget,M, AU - Goldenberg,R, AU - Niemoeller,E, AU - Muehlen-Bartmer,I, AU - Guo,H, AU - Aronson,R, Y1 - 2013/05/26/ PY - 2013/03/05/received PY - 2013/04/02/revised PY - 2013/04/23/accepted PY - 2013/5/1/entrez PY - 2013/5/1/pubmed PY - 2014/5/28/medline KW - glycaemic control KW - type 2 diabetes SP - 1000 EP - 7 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 15 IS - 11 N2 - AIMS: To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin. METHODS: This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period. Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) at week 24. RESULTS: In total, 484 patients were randomized: 323 to lixisenatide; 161 to placebo. After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (-0.84 mmol/l vs. placebo; p < 0.0001). There was a small decrease in body weight with lixisenatide once daily and a small increase with placebo, with no statistically significant difference between the two groups. Overall, lixisenatide once daily was well tolerated, with a similar proportion of treatment-emergent adverse events (TEAEs) and serious TEAEs between groups (lixisenatide: 72.4% and 2.5%; placebo: 72.7% and 1.9%). Symptomatic hypoglycaemia rates were also relatively low in both groups (lixisenatide 3.4% and placebo 1.2%), with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable extension period. CONCLUSIONS: Lixisenatide once daily significantly improved glycaemic control with a low risk of hypoglycaemia, and was well tolerated over 24 weeks and during the long-term, double-blind extension period in patients with T2DM insufficiently controlled on pioglitazone ± metformin. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/23627775/Efficacy_and_safety_of_lixisenatide_once_daily_versus_placebo_in_type_2_diabetes_insufficiently_controlled_on_pioglitazone__GetGoal_P__ L2 - https://doi.org/10.1111/dom.12121 DB - PRIME DP - Unbound Medicine ER -