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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR LIXISENATIDE

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Clinical Trials for Lixisenatide

Trial ID Title Status Sponsor Phase Summary
NCT00688701 GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy Completed Sanofi Phase 3 The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12. Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
NCT00707031 GLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin Completed Sanofi Phase 3 The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), 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 in comparison to exenatide (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (<=) 6.5%, fasting plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper gastrointestinal disorders - quality of life [PAGI-QOL]).
NCT00712673 GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin Completed Sanofi Phase 3 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 as an add-on treatment to metformin in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effect of lixisenatide, in comparison to placebo, when administered in the evening within 1 hour prior to the meal in terms of HbA1c reduction, percentage of patients reaching HbA1c less than (<) 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), plasma glucose, plasma insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test (only in morning injection arms), body weight, beta-cell function assessed by homeostasis model assessment (HOMA)-beta, fasting plasma insulin (FPI) and adiponectin; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development, beta-cell function 4 weeks after study drug discontinuation (only in patients from the morning injection arms in some selected centers).
NCT00713830 GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea Completed Sanofi Phase 3 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 sulfonylurea without or with 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 sulfonylurea with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than (<) 7 percent (%); percentage of patients reaching HbA1c less than or equal to (<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG), glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a sub-study in all patients in selected centers; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Lixisenatide

Condition Name

Condition Name for Lixisenatide
Intervention Trials
Type 2 Diabetes Mellitus 20
Diabetes Mellitus, Type 2 11
Type 2 Diabetes 6
Diabetes Mellitus 5
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Condition MeSH

Condition MeSH for Lixisenatide
Intervention Trials
Diabetes Mellitus 43
Diabetes Mellitus, Type 2 41
Gastroesophageal Reflux 1
Hypoglycemia 1
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Clinical Trial Locations for Lixisenatide

Trials by Country

Trials by Country for Lixisenatide
Location Trials
United States 265
Germany 21
Romania 14
Mexico 13
Russian Federation 13
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Trials by US State

Trials by US State for Lixisenatide
Location Trials
California 12
New Jersey 10
Texas 10
Pennsylvania 9
Michigan 9
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Clinical Trial Progress for Lixisenatide

Clinical Trial Phase

Clinical Trial Phase for Lixisenatide
Clinical Trial Phase Trials
Phase 4 7
Phase 3 27
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Lixisenatide
Clinical Trial Phase Trials
Completed 36
Recruiting 10
Not yet recruiting 2
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Clinical Trial Sponsors for Lixisenatide

Sponsor Name

Sponsor Name for Lixisenatide
Sponsor Trials
Sanofi 40
Profil Institut für Stoffwechselforschung GmbH 2
University Hospital, Toulouse 1
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Sponsor Type

Sponsor Type for Lixisenatide
Sponsor Trials
Industry 44
Other 16
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Serving hundreds of leading biopharmaceutical companies globally:

UBS
US Department of Justice
Moodys
Julphar
Cipla
Covington
Chinese Patent Office
Farmers Insurance
QuintilesIMS

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