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: May 6, 2014
Last verified: May 2014

January 16, 2012
May 6, 2014
February 2012
May 2013   (final data collection date for primary outcome measure)
Change in HbA1c from baseline to week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
Change in HbA1c [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01517412 on ClinicalTrials.gov Archive Site
  • Percentage of patients reaching HbA1c <7 % at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c ≤6.5 % at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c <7% at week 24 and not experiencing confirmed (Plasma Glucose (PG) <60mg/dL) symptomatic hypoglycemia during the 24-week treatment period [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c<7% and having no weight gain at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c <7% and having no weight gain at week 24 and not experiencing confirmed (Plasma Glucose (PG) <60mg/dL) symptomatic hypoglycemia during the 24-week treatment period [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c <7% and having a 2-h Postprandial Plasma Glucose (PPG) < 140mg/dL after breakfast or main meal (depending on the treatment group) at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change in 7-point self-monitored plasma glucose (SMPG) profiles from baseline to week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose (FPG) from baseline to week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
  • Change in body weight from baseline to week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
  • Change in treatment satisfaction from baseline to week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
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

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Lixisenatide (AVE0010)

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Device: Pen auto-injector
    Other Name: Opticlik®
  • Drug: Metformin
    To be kept at stable dose throughout the study
  • Experimental: Lixisenatide 1
    once daily within 1 hour prior to the main meal of the day (breakfast, lunch or dinner)
    Interventions:
    • Drug: Lixisenatide (AVE0010)
    • Device: Pen auto-injector
    • Drug: Metformin
  • Active Comparator: Lixisenatide 2
    once daily within 1 hour prior to breakfast
    Interventions:
    • Drug: Lixisenatide (AVE0010)
    • Device: Pen auto-injector
    • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
451
May 2013
May 2013   (final data collection date for primary outcome measure)

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
  • Alanine aminotransferase (ALT) > 3 ULN 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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   France,   Germany,   Poland,   Romania,   Russian Federation,   Spain,   Ukraine
 
NCT01517412
EFC12261, 2011-002416-85, U1111-1118-0841
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP