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 Metformin
Source: ClinicalTrials.gov NCT00763451 ↗Enrolled (actual)
484
Serious AEs
12.2%
Results posted
Dec 2016
Primary outcomePrimary: Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 — -0.42; -0.83; -0.92 percentage of hemoglobin — p=<0.0001
◆ Published Evidence
Highly cited
142citations · ~12 / year
Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1).
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 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 metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24.
Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Linked Publications (3)
-
Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1).
-
Efficacy and safety of low-dose otelixizumab anti-CD3 monoclonal antibody in preserving C-peptide secretion in adolescent type 1 diabetes: DEFEND-2, a randomized, placebo-controlled, double-blind, multi-centre study.
-
Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 |
-0.42; -0.83; -0.92 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
0.11; -0.56; -0.53 | — |
| SECONDARY Change From Baseline in Body Weight at Week 24 |
-1.63; -2.68; -2.63 | — |
| SECONDARY Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24 |
24.1; 42.1; 47.4 | — |
| SECONDARY Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24 |
7.6; 20.4; 25.6 | — |
| SECONDARY Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period |
4.4; 3.1; 1.3 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 gram/day for at least 3 months prior to screening visit
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 the 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
- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
- Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example, exenatide, liraglutide) or to metacresol
- Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (>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 (NCT00763451) 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.