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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

  Hide Study Locations
Locations
United States, Arizona
Investigational Site Number 840112
Glendale, Arizona, United States, 85306
Investigational Site Number 840113
Mesa, Arizona, United States, 85213
Investigational Site Number 840105
Phoenix, Arizona, United States, 85028
Investigational Site Number 840102
Tempe, Arizona, United States, 85282
Investigational Site Number 840107
Tempe, Arizona, United States
United States, California
Investigational Site Number 840116
Mission Viejo, California, United States, 92691
Investigational Site Number 840103
Northridge, California, United States, 91325
Investigational Site Number 840118
Redlands, California, United States, 92374
Investigational Site Number 840104
Temecula, California, United States, 92591
United States, Illinois
Investigational Site Number 840122
Chicago, Illinois, United States, 60611
Investigational Site Number 840119
Chicago, Illinois, United States, 60616
Investigational Site Number 840114
Springfield, Illinois, United States, 62704
United States, Michigan
Investigational Site Number 840120
Flint, Michigan, United States, 48504
United States, Montana
Investigational Site Number 840115
Billings, Montana, United States, 59103
United States, New Jersey
Investigational Site Number 840101
Sea Girt, New Jersey, United States, 08750
United States, North Dakota
Investigational Site Number 840111
Fargo, North Dakota, United States, 58103
United States, Utah
Investigational Site Number 840110
West Jordan, Utah, United States, 84088
Canada
Investigational Site Number 124102
Brampton, Canada, L6R 3J5
Investigational Site Number 124108
Coquitlam, Canada, V3K 3P4
Investigational Site Number 124106
Etobicoke, Canada, M9R 4E1
Investigational Site Number 124113
Kelowna, Canada, V1Y 1Z9
Investigational Site Number 124110
Laval, Canada, H7T 2P5
Investigational Site Number 124103
Newmarket, Canada, L3Y 5G8
Investigational Site Number 124101
Oakville, Canada, L6H 3P1
Investigational Site Number 124111
St-Romuald, Canada, G6W 5M6
Investigational Site Number 124104
Thornhill, Canada, L4J 8L7
Investigational Site Number 124105
Toronto, Canada, M9V 4B4
Investigational Site Number 124112
Vancouver, Canada, V5Z 1M9
Czech Republic
Investigational Site Number 203104
Plzen, Czech Republic, 32600
Investigational Site Number 203101
Praha 10, Czech Republic, 10034
Investigational Site Number 203102
Praha 10, Czech Republic, 10000
Investigational Site Number 203105
Praha 2, Czech Republic, 12808
Investigational Site Number 203103
Trutnov, Czech Republic, 54101
Investigational Site Number 203106
Ujezd U Brna, Czech Republic, 664 53
France
Investigational Site Number 250108
Clermont Ferrand, France, 63000
Investigational Site Number 250102
Menton, France, 06500
Investigational Site Number 250103
Nanterre, France, 92014
Investigational Site Number 250105
Rennes, France, 35700
Germany
Investigational Site Number 276103
Asslar, Germany, 35614
Investigational Site Number 276102
Bad Mergentheim, Germany, 97980
Investigational Site Number 276107
Berlin, Germany, 13125
Investigational Site Number 276101
Heidelberg, Germany, 69115
Investigational Site Number 276104
Künzing, Germany, 94550
Investigational Site Number 276105
Pirna, Germany, 01796
Investigational Site Number 276108
St. Ingbert-Oberwürzbach, Germany, 66386
Poland
Investigational Site Number 616106
Bytom, Poland, 41-902
Investigational Site Number 616102
Gdansk, Poland, 80-858
Investigational Site Number 616101
Krakow, Poland, 31-450
Investigational Site Number 616103
Lublin, Poland, 20-538
Investigational Site Number 616108
Oswiecim, Poland, 32-600
Investigational Site Number 616104
Wroclaw, Poland, 50-306
Investigational Site Number 616105
Wroclaw, Poland, 50-127
Investigational Site Number 616107
Wroclaw, Poland, 50-403
Romania
Investigational Site Number 642101
Bucuresti, Romania, 050538
Investigational Site Number 642105
Oradea, Romania, 410169
Investigational Site Number 642102
Ploiesti, Romania, 100097
Investigational Site Number 642104
Resita, Romania, 320076
Investigational Site Number 642103
Timisoara, Romania, 300456
Russian Federation
Investigational Site Number 643101
Moscow, Russian Federation, 125367
Investigational Site Number 643103
Moscow, Russian Federation, 119435
Investigational Site Number 643106
Nizhny Novgorod, Russian Federation, 603018
Investigational Site Number 643102
Samara, Russian Federation, 443067
Investigational Site Number 643110
St-Petersburg, Russian Federation, 195257
Investigational Site Number 643107
St-Petersburg, Russian Federation, 194291
Investigational Site Number 643105
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643108
Vladimir, Russian Federation, 600023
Investigational Site Number 643104
Voronezh, Russian Federation, 394018
Spain
Investigational Site Number 724103
Barcelona, Spain, 08041
Investigational Site Number 724104
Barcelona, Spain, 08020
Investigational Site Number 724102
El Ferrol, Spain, 15403
Investigational Site Number 724101
Hostalets De Balenyà, Spain, 08550
Investigational Site Number 724107
La Coruña, Spain, 15006
Investigational Site Number 724106
Málaga, Spain, 29010
Investigational Site Number 724108
Segovia, Spain, 40002
Investigational Site Number 724105
Sevilla, Spain, 41014
Ukraine
Investigational Site Number 804108
Kharkiv, Ukraine, 61002
Investigational Site Number 804105
Kharkov, Ukraine, 61022
Investigational Site Number 804102
Kiev, Ukraine, 2091
Investigational Site Number 804103
Kyiv, Ukraine, 04114
Investigational Site Number 804104
Mykolaiv, Ukraine, 54003
Investigational Site Number 804106
Poltava, Ukraine, 36011
Investigational Site Number 804101
Zaporozhie, Ukraine, 69600
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014