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
  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)
Device: Pen auto-injector
Drug: Metformin
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 from baseline to week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 451
Study Start Date: February 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

Route of administration: subcutaneous

Device: Pen auto-injector
Other Name: Opticlik®
Drug: Metformin
To be kept at stable dose throughout the study
Active Comparator: Lixisenatide 2
once daily within 1 hour prior to breakfast
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

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
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 6, 2014
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 July 23, 2014