Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes | RxWiki

Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose	Primary Objective: - To investigate the effects of lixisenatide as compared to liraglutide in reducing Postprandial Plasma Glucose (PPG) after a standardized breakfast in patients with type 2 diabetes Secondary Objectives: - To assess the effects of lixisenatide as compared to liraglutide after a 4-week treatment period in patients with type 2 diabetes: - on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast - on the 24-h profile of plasma glucose - on Glycosylated hemoglobin (HbA1c) - on satiety markers (obestatin, PYY-36 and oxyntomodulin) - To assess the clinical and laboratory safety profile of lixisenatide and liraglutide over a 4-week treatment period in patients with type 2 diabetes
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Lixisenatide (AVE0010) Drug: Liraglutide Drug: Metformin
Phase	Phase 2
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT01175473
First Received	August 2, 2010
Last Updated	October 22, 2012
Last verified	October 2012

Tracking Information[ + expand ][ + ]

First Received Date	August 2, 2010
Last Updated Date	October 22, 2012
Start Date	August 2010
Estimated Primary Completion Date	November 2010
Current Primary Outcome Measures	Postprandial Plasma Glucose (PPG): change from baseline in area under curve AUC 0:30-4:30h [Time Frame: Baseline, Day 28] [Designated as safety issue: No]Change from baseline in the area under the corrected (ie, relative to the premeal glucose concentration) plasma glucose concentration-time curve calculated using the linear trapezoidal rule (GLU-AUC 0:30-4:30), determined from glucose assessments on Day 28 from the time of standardized breakfast start (30 minutes after study medication injection) to 4 hours after injection
Current Secondary Outcome Measures	Postprandial Plasma Glucose (PPG): change from baseline in PPG excursion [Time Frame: Baseline, Day 28] [Designated as safety issue: No]Change from baseline in postprandial plasma glucose excursion (maximal postprandial change in plasma glucose) determined from the time of breakfast start (30 minutes after study medication injection) on Day 28 to 4 hours later, relative to the premeal plasma glucose concentration Insulin plasma concentrations : change from baseline in area under curve AUC 0:30-4:30h [Time Frame: Baseline, Day 28] [Designated as safety issue: No]Change from baseline in corrected (ie, relative to the premeal value) AUC 0:30-4:30 for the postprandial plasma concentrations for insulin determined from the time of standardized breakfast start (30 minutes after study medication injection) to 4 hours later on Day 28 (7-timepoint profile) Pro-insulin plasma concentrations : change from baseline in area under curve AUC 0:30-4:30h [Time Frame: Baseline, Day 28] [Designated as safety issue: No]Change from baseline in corrected (ie, relative to the premeal value) AUC 0:30-4:30 for the postprandial plasma concentrations for pro-insulin determined from the time of standardized breakfast start (30 minutes after study medication injection) to 4 hours later on Day 28 (7-timepoint profile) C-peptide plasma concentrations : change from baseline in area under curve AUC 0:30-4:30h [Time Frame: Baseline, Day 28] [Designated as safety issue: No]Change from baseline in corrected (ie, relative to the premeal value) AUC 0:30-4:30 for the postprandial plasma concentrations for C-peptide determined from the time of standardized breakfast start (30 minutes after study medication injection) to 4 hours later on Day 28 (7-timepoint profile) Glucagon plasma concentrations : change from baseline in area under curve AUC 0:30-4:30h [Time Frame: Baseline, Day 28] [Designated as safety issue: No]Change from baseline in corrected (ie, relative to the premeal value) AUC 0:30-4:30 for the postprandial plasma concentrations for glucagon determined from the time of standardized breakfast start (30 minutes after study medication injection) to 4 hours later on Day 28 (7-timepoint profile) Glycosylated hemoglobin HbA1c : change from baseline to Day 28 [Time Frame: Baseline, Day 28] [Designated as safety issue: No] Satiety markers (PYY-36, oxyntomodulin and obestatin): change from baseline to Day 28 [Time Frame: Baseline, Day 28] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes
Official Title	An Open-label, Randomized 2-arm Parallel Group Study to Compare the Effects of 4-week QD Treatment With Lixisenatide or Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin
Brief Summary	Primary Objective: - To investigate the effects of lixisenatide as compared to liraglutide in reducing Postprandial Plasma Glucose (PPG) after a standardized breakfast in patients with type 2 diabetes Secondary Objectives: - To assess the effects of lixisenatide as compared to liraglutide after a 4-week treatment period in patients with type 2 diabetes: - on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast - on the 24-h profile of plasma glucose - on Glycosylated hemoglobin (HbA1c) - on satiety markers (obestatin, PYY-36 and oxyntomodulin) - To assess the clinical and laboratory safety profile of lixisenatide and liraglutide over a 4-week treatment period in patients with type 2 diabetes
Detailed Description	The duration of the study for each patient was up to 7 weeks including a screening period up to 2 weeks, a treatment period of 4 weeks (Day 1 to Day 28), and an end-of-study visit 7± 2 days after the last dose.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Lixisenatide (AVE0010) Pharmaceutical form:Solution for injection Route of administration: subcutaneous Drug: Liraglutide Pharmaceutical form:Solution for injection Route of administration: subcutaneous Drug: Metformin continued at a stable dose throughout the study
Study Arm (s)	Experimental: lixisenatide Lixisenatide will be uptitrated starting with 10 μg subcutaneous (s.c.) once daily (QD) for fourteen days and followed by fourteen days with 20 μg s.c. QD Active Comparator: liraglutide Liraglutide will be uptitrated starting with 0.6 mg s.c. once daily (QD) for seven days, followed by 1.2 mg s.c. once daily (QD) for seven days, and by fourteen days with 1.8 mg once daily (QD)

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	148
Estimated Completion Date	November 2010
Estimated Primary Completion Date	November 2010
Eligibility Criteria	Inclusion criteria: - Patients with type 2 diabetes mellitus as defined by World Health Organization (fasting plasma glucose ≥ 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year at the time of screening visit, not adequately controlled by metformin at a dose of at least 1.5 g/day for at least 3 months prior to screening - Glycosylated hemoglobin HbA1c ≥ 6.5% (as recommended by the American Diabetes Association) and HbA1c ≤ 9% at screening Exclusion criteria: - At the time of screening age < 18 years or ≥ 74 years - Body Mass Index (BMI) : ≤ 20 kg/m² or ≥ 37 kg/m² - Pregnant women or breast feeding women - Women of childbearing potential with no effective contraceptive method - Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, Dipeptidyl peptide IV (DPP-IV) inhibitors, insulin, thiazolidinedione (TZD), sulfonylurea (SU) etc.) within 3 months prior to the time of screening - Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide) or to metacresol - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease - Personal or family history of Medullary Thyroid Cancer (MTC) or a genetic condition that predisposes to MTC The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT01175473
Other Study ID Numbers	PDY10931
Has Data Monitoring Committee	No
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Not Provided
Investigators	Study Director: Clinical Sciences & Operations Sanofi
Verification Date	October 2012

Locations[ + expand ][ + ]

Sanofi-Aventis Investigational Site Number 276006	Berlin, Germany, 14050
Sanofi-Aventis Investigational Site Number 276004	Kiel, Germany, 24105
Sanofi-Aventis Investigational Site Number 276002	Mainz, Germany, 55116
Sanofi-Aventis Investigational Site Number 276003	Mannheim, Germany, 68167
Sanofi-Aventis Investigational Site Number 276005	Mönchengladbach, Germany, 41061
Sanofi-Aventis Investigational Site Number 276007	München, Germany, 80636
Sanofi-Aventis Investigational Site Number 276001	Neuss, Germany, 41460