Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01517412
First received: January 16, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

Primary Objective:

- To compare the two treatment regimens in terms of change of HbA1c from baseline to endpoint (week 24)

Secondary Objective:

  • To assess the effect of the 2 lixisenatide regimens on:

    • The percentage of patients who reached the target of HbA1c < 7% or ≤ 6.5% at week 24
    • Fasting Plasma Glucose (FPG)
    • 7-point Self-Monitored Plasma Glucose (SMPG) profiles
    • Body weight
  • To assess the safety and tolerability of the 2 lixisenatide regimens

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Lixisenatide (AVE0010)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients reaching HbA1c <7 % [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c ≤6.5 % [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Change in 7-point self-monitored plasma glucose profile [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Change in Fasting plasma glucose [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Change in Body weight [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lixisenatide 1
once daily within 1 hour prior to the main meal of the day (breakfast, lunch or dinner)
Drug: Lixisenatide (AVE0010)

Pharmaceutical form:Solution for injection using a re-usable pen-type self-injector device (Opticlick®).

Route of administration: subcutaneous

Active Comparator: Lixisenatide 2
once daily within 1 hour prior to breakfast
Drug: Lixisenatide (AVE0010)

Pharmaceutical form:Solution for injection using a re-usable pen-type self-injector device (Opticlick®).

Route of administration: subcutaneous


Detailed Description:

The maximum study duration will be 28 weeks per patient, including a 24-week randomized treatment period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit
  • Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.

Exclusion criteria:

  • Screening HbA1c < 7.0% and > 10.0%
  • Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)
  • Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin
  • Patients who usually do not eat breakfast
  • Type 1 diabetes mellitus
  • Body Mass Index (BMI) ≤ 20 kg/m² and > 40 kg/ m²
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
  • Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN) at screening
  • ALT > 3ULN at screening
  • Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g multiple endocrine neoplasia syndromes)
  • Any contra-indication related to metformin
  • Any previous treatment with lixisenatide

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: NCT01517412

  Show 82 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01517412     History of Changes
Other Study ID Numbers: EFC12261, 2011-002416-85, U1111-1118-0841
Study First Received: January 16, 2012
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014