Clinical trial NCT01517412: Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

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

Secondary Objective:

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

  * The percentage of participants 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

Detailed description: The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.

Eligibility criteria: Inclusion criteria:

* Participants 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
* Participants who usually did not eat breakfast
* Type 1 diabetes mellitus
* Body Mass Index (BMI) ≤ 20 kg/m\^2 and \> 40 kg/m\^2
* 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24
timeFrame: Week 24
measure: Change in Average 7-point SMPG Profiles From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Change in FPG From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Change in Body Weight From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period
timeFrame: Week 24
measure: Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24
timeFrame: Week 24
measure: Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period
timeFrame: Week 24
measure: Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24
timeFrame: Week 24
measure: Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Investigational Site Number 840112
state: Arizona
city: Mesa
country: United States
facility: Investigational Site Number 840113
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840105
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840102
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840107
state: Arizona
city: Mission Viejo
country: United States
facility: Investigational Site Number 840116
state: California
city: Northridge
country: United States
facility: Investigational Site Number 840103
state: California
city: Redlands
country: United States
facility: Investigational Site Number 840118
state: California
city: Temecula
country: United States
facility: Investigational Site Number 840104
state: California
city: Chicago
country: United States
facility: Investigational Site Number 840122
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840119
state: Illinois
city: Springfield
country: United States
facility: Investigational Site Number 840114
state: Illinois
city: Flint
country: United States
facility: Investigational Site Number 840120
state: Michigan
city: Billings
country: United States
facility: Investigational Site Number 840115
state: Montana
city: Sea Girt
country: United States
facility: Investigational Site Number 840101
state: New Jersey
city: Fargo
country: United States
facility: Investigational Site Number 840111
state: North Dakota
city: West Jordan
country: United States
facility: Investigational Site Number 840110
state: Utah
city: Brampton
country: Canada
facility: Investigational Site Number 124102
city: Coquitlam
country: Canada
facility: Investigational Site Number 124108
city: Etobicoke
country: Canada
facility: Investigational Site Number 124106
city: Kelowna
country: Canada
facility: Investigational Site Number 124113
city: Laval
country: Canada
facility: Investigational Site Number 124110
city: Newmarket
country: Canada
facility: Investigational Site Number 124103
city: Oakville
country: Canada
facility: Investigational Site Number 124101
city: St-Romuald
country: Canada
facility: Investigational Site Number 124111
city: Thornhill
country: Canada
facility: Investigational Site Number 124104
city: Toronto
country: Canada
facility: Investigational Site Number 124105
city: Vancouver
country: Canada
facility: Investigational Site Number 124112
city: Plzen
country: Czech Republic
facility: Investigational Site Number 203104
city: Praha 10
country: Czech Republic
facility: Investigational Site Number 203102
city: Praha 10
country: Czech Republic
facility: Investigational Site Number 203101
city: Praha 2
country: Czech Republic
facility: Investigational Site Number 203105
city: Trutnov
country: Czech Republic
facility: Investigational Site Number 203103
city: Ujezd U Brna
country: Czech Republic
facility: Investigational Site Number 203106
city: Clermont Ferrand
country: France
facility: Investigational Site Number 250108
city: Menton
country: France
facility: Investigational Site Number 250102
city: Nanterre
country: France
facility: Investigational Site Number 250103
city: Rennes
country: France
facility: Investigational Site Number 250105
city: Asslar
country: Germany
facility: Investigational Site Number 276103
city: Bad Mergentheim
country: Germany
facility: Investigational Site Number 276102
city: Berlin
country: Germany
facility: Investigational Site Number 276107
city: Heidelberg
country: Germany
facility: Investigational Site Number 276101
city: Künzing
country: Germany
facility: Investigational Site Number 276104
city: Pirna
country: Germany
facility: Investigational Site Number 276105
city: St. Ingbert-Oberwürzbach
country: Germany
facility: Investigational Site Number 276108
city: Bytom
country: Poland
facility: Investigational Site Number 616106
city: Gdansk
country: Poland
facility: Investigational Site Number 616102
city: Krakow
country: Poland
facility: Investigational Site Number 616101
city: Lublin
country: Poland
facility: Investigational Site Number 616103
city: Oswiecim
country: Poland
facility: Investigational Site Number 616108
city: Wroclaw
country: Poland
facility: Investigational Site Number 616105
city: Wroclaw
country: Poland
facility: Investigational Site Number 616104
city: Wroclaw
country: Poland
facility: Investigational Site Number 616107
city: Bucuresti
country: Romania
facility: Investigational Site Number 642101
city: Oradea
country: Romania
facility: Investigational Site Number 642105
city: Ploiesti
country: Romania
facility: Investigational Site Number 642102
city: Resita
country: Romania
facility: Investigational Site Number 642104
city: Timisoara
country: Romania
facility: Investigational Site Number 642103
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643103
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643101
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number 643106
city: Samara
country: Russian Federation
facility: Investigational Site Number 643102
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643107
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643105
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643110
city: Vladimir
country: Russian Federation
facility: Investigational Site Number 643108
city: Voronezh
country: Russian Federation
facility: Investigational Site Number 643104
city: Barcelona
country: Spain
facility: Investigational Site Number 724104
city: Barcelona
country: Spain
facility: Investigational Site Number 724103
city: El Ferrol
country: Spain
facility: Investigational Site Number 724102
city: Hostalets De Balenyà
country: Spain
facility: Investigational Site Number 724101
city: La Coruña
country: Spain
facility: Investigational Site Number 724107
city: Málaga
country: Spain
facility: Investigational Site Number 724106
city: Segovia
country: Spain
facility: Investigational Site Number 724108
city: Sevilla
country: Spain
facility: Investigational Site Number 724105
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804108
city: Kharkov
country: Ukraine
facility: Investigational Site Number 804105
city: Kiev
country: Ukraine
facility: Investigational Site Number 804102
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804103
city: Mykolaiv
country: Ukraine
facility: Investigational Site Number 804104
city: Poltava
country: Ukraine
facility: Investigational Site Number 804106
city: Zaporozhie
country: Ukraine
facility: Investigational Site Number 804101
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Ahren B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R. Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5.