Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01175473
First received: August 2, 2010
Last updated: October 22, 2012
Last verified: October 2012
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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 | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Lixisenatide (AVE0010) Drug: Liraglutide Drug: Metformin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
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
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 ]
| Enrollment: | 148 |
| Study Start Date: | August 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Drug: Lixisenatide (AVE0010)
Pharmaceutical form:Solution for injection Route of administration: subcutaneous continued at a stable dose throughout the study
|
|
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)
|
Drug: Liraglutide
Pharmaceutical form:Solution for injection Route of administration: subcutaneous continued at a stable dose throughout the study
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175473
Locations
| Germany | |
| 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 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01175473 History of Changes |
| Other Study ID Numbers: | PDY10931, 2009-017666-23, U1111-1116-9040 |
| Study First Received: | August 2, 2010 |
| Last Updated: | October 22, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Glucagon-Like Peptide 1 |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013