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Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data.

ABSTRACT: Background:To examine the impact on glycemic control of achieving postprandial glucose (PPG) target with lixisenatide, a once-daily glucagon-like peptide-1 receptor agonist approved in the US, in patients with uncontrolled type 2 diabetes (T2D) on basal insulin, an agent that primarily targets fasting plasma glucose. Methods:A post hoc pooled analysis was conducted using clinical trial data extracted from the intent-to-treat subpopulation of patients with T2D who participated in the 24-week, phase 3, randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter GetGoal-L (NCT00715624), GetGoal-Duo 1 (NCT00975286) and GetGoal-L Asia trials (NCT00866658). Results:Data from 587 lixisenatide-treated patients and 484 placebo-treated patients were included. Patients on lixisenatide were more likely to achieve a PPG target of?

SUBMITTER: Davidson JA

PROVIDER: S-EPMC6961286 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data.

Davidson Jaime A JA Stager William W Paranjape Sachin S Berria Rachele R Leiter Lawrence A LA

Clinical diabetes and endocrinology 20200114

<h4>Background</h4>To examine the impact on glycemic control of achieving postprandial glucose (PPG) target with lixisenatide, a once-daily glucagon-like peptide-1 receptor agonist approved in the US, in patients with uncontrolled type 2 diabetes (T2D) on basal insulin, an agent that primarily targets fasting plasma glucose.<h4>Methods</h4>A post hoc pooled analysis was conducted using clinical trial data extracted from the intent-to-treat subpopulation of patients with T2D who participated in t ...[more]

PMID: 31956422

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Project description:IntroductionFew prospective clinical trials have investigated the role of fasting blood glucose (FBG) and/or postprandial glucose (PPG) in assessing overall glycemic control by using different insulin regimens. In the present post hoc analysis, we assessed the contribution of FBG and/or PPG in overall glycemic control in Chinese patients under insulin treatment.MethodsCLASSIFY is a phase IV, randomized, open-label, 26-week, parallel-arm, treat-to-target, multinational, controlled study in patients with type 2 diabetes mellitus to compare the efficacy and safety of insulin lispro mix 25 (LM25) and insulin lispro mix 50 (LM50) as starter insulins. Insulin was titrated with an aim to target pre-meal blood glucose (BG) levels at > 3.9 and ≤ 6.1 mmol/L before breakfast and dinner. The primary outcome assessed was the change in HbA1c from baseline.ResultsChinese patients contributed 38.7% (N = 156) of the total population. The majority of patients were male (52.6%). The mean (SD) body mass index was 24.54 (3.04) kg/m2 and mean (SD) HbA1c was 8.54 (1.10) % at baseline. At week 26, LM50 showed a significantly greater reduction from baseline in HbA1c (- 2.03% vs - 1.55%, P < 0.001), average daily BG (- 3.21 vs - 2.34 mmol/L, P < 0.001), average post-meal BG (- 3.58 vs - 2.39 mmol/L, P < 0.001), and average prandial BG excursion (- 1.01 vs - 0.22 mmol/L, P = 0.006) than the LM25 group. The reductions in average pre-meal BG (- 2.59 vs - 2.28 mmol/L, P = 0.137) were not significantly different between the groups. The proportion of patients achieving HbA1c targets (< 7% or ≤ 6.5%) without nocturnal hypoglycemia or weight gain was greater (P < 0.05) with LM50 compared with LM25.ConclusionLM50 achieved better overall glycemic control than LM25 as a starter insulin in Chinese patients, which may be due to greater improvement in PPG levels.Trial registrationClinicaltrials.gov identification number: NCT01773473.FundingEli Lilly and Company, Shanghai, China.

Dataset Information

Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data.

Publications

Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data.

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