Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

Overview

Primary Objective: To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29. Secondary Objectives: To demonstrate: – Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast – Delaying gastric emptying (13C-acetic acid breath test) – Safety and tolerability

Full Title of Study: “A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2015

Detailed Description

The duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances. 13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).

Interventions

  • Drug: LIXISENATIDE AVE0010
    • Pharmaceutical form:solution Route of administration: subcutaneous
  • Drug: Sitagliptin
    • Pharmaceutical form:tablet Route of administration: oral
  • Drug: Insulin glargine HOE901
    • Pharmaceutical form:solution Route of administration: subcutaneous

Arms, Groups and Cohorts

  • Experimental: Lixisenatide
    • Lyxumia solostar: Initially started with 10 μg once-daily and increased up to 20 μg once daily (dose increased by 5 μg every week), subcutaneous injection in the abdomen, administered 30 minutes before breakfast. The period of administration is 4 weeks. Lantus solostar as base treatment: Subcutaneous injection in the abdomen.
  • Active Comparator: Sitagliptin – Januvia
    • 50 mg tablet, administered orally once-daily, 30 minutes before breakfast. The period of administration is 4 weeks. Lantus solostar as base treatment: Subcutaneous injection in the abdomen.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast
    • Time Frame: Day 29 after first intake of investigational product

Secondary Measures

  • Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast
    • Time Frame: Day 29 after first intake of investigational product
  • Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast
    • Time Frame: Day 29 after first intake of investigational product
  • Change from baseline in glucagon levels at Day 29 after a standardized breakfast
    • Time Frame: Day 29 after first intake of investigational product
  • Change in gastric emptying half life (13C-acetic acid breath test)
    • Time Frame: Day 29 after first intake of investigational product
  • Proportion of patients with adverse events
    • Time Frame: Up to Day 33 from the first intake of investigational medicinal product

Participating in This Clinical Trial

Inclusion Criteria

  • Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis – Aged 20-75 years – Hemoglobin A1C ≥7.0%-≤10.0% – Fasting plasma glucose ≤180 mg/dL at screening – Stable treatment (±20%) with Lantus for 3 months or more prior to screening. – Sulfonylurea dose stable for 3 months or more prior to screening Exclusion criteria:

  • Type 1 diabetes mellitus – Pregnancy or lactation – Hypersensitivity to Lixisenatide – Severely uncontrolled glycemic situation – History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease – History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening – History within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse – Uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg – Amylase and/or lipase >3 times or aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) >2 times the upper limit of the normal laboratory range – End-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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