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 is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01517412
First received: January 16, 2012
Last updated: February 11, 2013
Last verified: February 2013
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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) |
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 [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated 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 using a re-usable pen-type self-injector device (Opticlick®). Route of administration: subcutaneous |
|
Active Comparator: Lixisenatide 2
once daily within 1 hour prior to breakfast
|
Drug: Lixisenatide (AVE0010)
Pharmaceutical form:Solution for injection using a re-usable pen-type self-injector device (Opticlick®). Route of administration: subcutaneous |
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
- ALT > 3ULN 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517412
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| 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 643105 | |
| St-Petersburg, Russian Federation, 194354 | |
| Investigational Site Number 643107 | |
| St-Petersburg, Russian Federation, 194291 | |
| Investigational Site Number 643110 | |
| St-Petersburg, Russian Federation, 195257 | |
| Investigational Site Number 643108 | |
| Vladimir, Russian Federation, 600023 | |
| Investigational Site Number 643104 | |
| Voronezh, Russian Federation, 394018 | |
| Spain | |
| Investigational Site Number 724104 | |
| Barcelona, Spain, 08020 | |
| Investigational Site Number 724103 | |
| Barcelona, Spain, 08041 | |
| 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: | February 11, 2013 |
| 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 May 23, 2013