Phase 3
Completed N=484
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone
Source: ClinicalTrials.gov NCT00763815 ↗Enrolled (actual)
484
Serious AEs
8.3%
Results posted
Oct 2016
Primary outcomePrimary: Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 — -0.34; -0.90 percentage of hemoglobin — p=<0.0001
◆ Published Evidence
Highly cited
137citations · ~11 / year
Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).
Summary
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension.
The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.
Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Linked Publications
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Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 |
-0.34; -0.90 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
-0.32; -1.16 | — |
| SECONDARY Change From Baseline in Body Weight at Week 24 |
0.21; -0.21 | — |
| SECONDARY Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24 |
-1.01; -10.36 | — |
| SECONDARY Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24 |
26.4; 52.3 | — |
| SECONDARY Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24 |
10.1; 28.9 | — |
| SECONDARY Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24 |
6.98; 6.72 | — |
| SECONDARY Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period |
11.3; 3.8 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with pioglitazone
Exclusion Criteria
- HbA1c less than ( ) 10% at screening
- At the time of screening age 250 milligram per deciliter (mg/dL) (>13.9 millimole per liter [mmol/L])
- Body mass index less than or equal to ( 180 millimeter of mercury (mmHg) or >95 mmHg, respectively
- Laboratory findings at the time of screening: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP): >2 times upper limit of normal (ULN) laboratory range; amylase and/or lipase: >3 times ULN; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); Hemoglobin 1.4 mg/dL in women and creatinine >1.5 mg/dL in men (applicable only for patients with metformin treatment)
- Patients with cardiac failure or history of cardiac failure (New York Heart Association class I to IV)
- End-stage renal disease defined by a serum creatinine clearance of 2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator
Data sourced from ClinicalTrials.gov (NCT00763815) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.