Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
NCT ID: NCT01517412
Last Updated: 2016-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
451 participants
INTERVENTIONAL
2012-02-29
2013-05-31
Brief Summary
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\- 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lixisenatide Main Meal
Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Lixisenatide (AVE0010)
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Self-injector pen device (OptiClik®)
Metformin
To be kept at stable dose (≥1.5 g/day) throughout the study.
Lixisenatide Breakfast
Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Lixisenatide (AVE0010)
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Self-injector pen device (OptiClik®)
Metformin
To be kept at stable dose (≥1.5 g/day) throughout the study.
Interventions
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Lixisenatide (AVE0010)
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Self-injector pen device (OptiClik®)
Metformin
To be kept at stable dose (≥1.5 g/day) throughout the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840112
Glendale, Arizona, United States
Investigational Site Number 840113
Mesa, Arizona, United States
Investigational Site Number 840105
Phoenix, Arizona, United States
Investigational Site Number 840102
Tempe, Arizona, United States
Investigational Site Number 840107
Tempe, Arizona, United States
Investigational Site Number 840116
Mission Viejo, California, United States
Investigational Site Number 840103
Northridge, California, United States
Investigational Site Number 840118
Redlands, California, United States
Investigational Site Number 840104
Temecula, California, United States
Investigational Site Number 840122
Chicago, Illinois, United States
Investigational Site Number 840119
Chicago, Illinois, United States
Investigational Site Number 840114
Springfield, Illinois, United States
Investigational Site Number 840120
Flint, Michigan, United States
Investigational Site Number 840115
Billings, Montana, United States
Investigational Site Number 840101
Sea Girt, New Jersey, United States
Investigational Site Number 840111
Fargo, North Dakota, United States
Investigational Site Number 840110
West Jordan, Utah, United States
Investigational Site Number 124102
Brampton, , Canada
Investigational Site Number 124108
Coquitlam, , Canada
Investigational Site Number 124106
Etobicoke, , Canada
Investigational Site Number 124113
Kelowna, , Canada
Investigational Site Number 124110
Laval, , Canada
Investigational Site Number 124103
Newmarket, , Canada
Investigational Site Number 124101
Oakville, , Canada
Investigational Site Number 124111
Saint Romuald, , Canada
Investigational Site Number 124104
Thornhill, , Canada
Investigational Site Number 124105
Toronto, , Canada
Investigational Site Number 124112
Vancouver, , Canada
Investigational Site Number 203104
Pilsen, , Czechia
Investigational Site Number 203102
Prague, , Czechia
Investigational Site Number 203101
Prague, , Czechia
Investigational Site Number 203105
Prague, , Czechia
Investigational Site Number 203103
Trutnov, , Czechia
Investigational Site Number 203106
Újezd u Brna, , Czechia
Investigational Site Number 250108
Clermont-Ferrand, , France
Investigational Site Number 250102
Menton, , France
Investigational Site Number 250103
Nanterre, , France
Investigational Site Number 250105
Rennes, , France
Investigational Site Number 276103
Aßlar, , Germany
Investigational Site Number 276102
Bad Mergentheim, , Germany
Investigational Site Number 276107
Berlin, , Germany
Investigational Site Number 276101
Heidelberg, , Germany
Investigational Site Number 276104
Künzing, , Germany
Investigational Site Number 276105
Pirna, , Germany
Investigational Site Number 276108
Saint Ingbert-Oberwürzbach, , Germany
Investigational Site Number 616106
Bytom, , Poland
Investigational Site Number 616102
Gdansk, , Poland
Investigational Site Number 616101
Krakow, , Poland
Investigational Site Number 616103
Lublin, , Poland
Investigational Site Number 616108
Oświęcim, , Poland
Investigational Site Number 616105
Wroclaw, , Poland
Investigational Site Number 616104
Wroclaw, , Poland
Investigational Site Number 616107
Wroclaw, , Poland
Investigational Site Number 642101
Bucharest, , Romania
Investigational Site Number 642105
Oradea, , Romania
Investigational Site Number 642102
Ploieşti, , Romania
Investigational Site Number 642104
Reşiţa, , Romania
Investigational Site Number 642103
Timișoara, , Romania
Investigational Site Number 643103
Moscow, , Russia
Investigational Site Number 643101
Moscow, , Russia
Investigational Site Number 643106
Nizhny Novgorod, , Russia
Investigational Site Number 643107
Saint Petersburg, , Russia
Investigational Site Number 643105
Saint Petersburg, , Russia
Investigational Site Number 643110
Saint Petersburg, , Russia
Investigational Site Number 643102
Samara, , Russia
Investigational Site Number 643108
Vladimir, , Russia
Investigational Site Number 643104
Voronezh, , Russia
Investigational Site Number 724107
A Coruña, , Spain
Investigational Site Number 724104
Barcelona, , Spain
Investigational Site Number 724103
Barcelona, , Spain
Investigational Site Number 724102
Ferrol, , Spain
Investigational Site Number 724101
Hostalets de Balenyà, , Spain
Investigational Site Number 724106
Málaga, , Spain
Investigational Site Number 724108
Segovia, , Spain
Investigational Site Number 724105
Seville, , Spain
Investigational Site Number 804108
Kharkiv, , Ukraine
Investigational Site Number 804105
Kharkiv, , Ukraine
Investigational Site Number 804102
Kiev, , Ukraine
Investigational Site Number 804103
Kyiv, , Ukraine
Investigational Site Number 804104
Mykolaiv, , Ukraine
Investigational Site Number 804106
Poltava, , Ukraine
Investigational Site Number 804101
Zaporozhie, , Ukraine
Countries
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References
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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.
Other Identifiers
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2011-002416-85
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1118-0841
Identifier Type: OTHER
Identifier Source: secondary_id
EFC12261
Identifier Type: -
Identifier Source: org_study_id
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