Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients
Overview[ - collapse ][ - ]
Purpose | Primary Objective: - The purpose of this study is to compare insulin glargine/ lixisenatide fixed ratio combination versus insulin glargine on glycemic control over 24 weeks, as evaluated by HbA1c (glycosylated hemoglobin) reduction in type 2 diabetic patients treated with metformin Secondary Objectives: - To compare insulin glargine/lixisenatide fixed ratio combination versus insulin glargine over 24 weeks on: - Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test - Percentage of patients reaching HbA1c <7% or ≤6.5% - 7-point Self-Monitored Plasma Glucose (SMPG) profile - Body weight - Insulin glargine dose - Fasting Plasma Glucose (FPG) - Percentage of patients requiring rescue therapy during the 24-week open label treatment period - To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio combination. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Insulin glargine /lixisenatide fixed ratio combination (HOE901/AVE0010) Drug: Insulin glargine (HOE901) Drug: Metformin Device: re-usable pen-type self-injector device Device: disposable self injector device |
Phase | Phase 2 |
Sponsor | Sanofi |
Responsible Party | Sanofi |
ClinicalTrials.gov Identifier | NCT01476475 |
First Received | November 4, 2011 |
Last Updated | January 27, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | November 4, 2011 |
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Last Updated Date | January 27, 2014 |
Start Date | November 2011 |
Estimated Primary Completion Date | December 2012 |
Current Primary Outcome Measures | Change in HbA1c [Time Frame: from baseline to week 24] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients |
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Official Title | A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients |
Brief Summary | Primary Objective: - The purpose of this study is to compare insulin glargine/ lixisenatide fixed ratio combination versus insulin glargine on glycemic control over 24 weeks, as evaluated by HbA1c (glycosylated hemoglobin) reduction in type 2 diabetic patients treated with metformin Secondary Objectives: - To compare insulin glargine/lixisenatide fixed ratio combination versus insulin glargine over 24 weeks on: - Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test - Percentage of patients reaching HbA1c <7% or ≤6.5% - 7-point Self-Monitored Plasma Glucose (SMPG) profile - Body weight - Insulin glargine dose - Fasting Plasma Glucose (FPG) - Percentage of patients requiring rescue therapy during the 24-week open label treatment period - To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio combination. |
Detailed Description | Approximately 27 weeks including a 24-week treatment period |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Insulin glargine /lixisenatide fixed ratio combination (HOE901/AVE0010) Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Insulin glargine (HOE901) Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Metformin Route of administration: oral Device: re-usable pen-type self-injector device Other Names: Tactipen®Device: disposable self injector device Other Names: Lantus® SoloSTAR® |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 323 |
Estimated Completion Date | December 2012 |
Estimated Primary Completion Date | December 2012 |
Eligibility Criteria | Inclusion criteria: - Patient with type 2 diabetes mellitus diagnosed for at least 1 year. - Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening. Exclusion criteria: - Age < legal age of adulthood - Screening HbA1c < 7% or > 10% - Screening FPG > 250 mg/dL (> 13.9 mmol/L) - Pregnancy or lactation, women of childbearing potential with no effective contraceptive method - Type 1 diabetes mellitus - Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening - Use of insulin within the last 6 months - Previous use of insulin, except for episode(s) of short-term treatment (≤ 15 consecutive days) due to intercurrent illness - Amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN) at screening - Calcitonin ≥ 20 pg/ml (5.9 pmol/l) at screening - Alanine Transferase (ALT)> 3ULN 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) - Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively - Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures - Body Mass Index (BMI) ≤ 20 or > 40 kg/m² - 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Chile, Czech Republic, Denmark, France, Germany, Hungary, Lithuania, Mexico, Poland, Romania, Slovakia, Sweden |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01476475 |
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Other Study ID Numbers | ACT12374 |
Has Data Monitoring Committee | Yes |
Information Provided By | Sanofi |
Study Sponsor | Sanofi |
Collaborators | Not Provided |
Investigators | Study Director: Clinical Sciences & Operations Sanofi |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Investigational Site Number 840408 | Little Rock, Arkansas, United States, 72205 |
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Investigational Site Number 840412 | Paramount, California, United States, 90723 |
Investigational Site Number 840401 | Larenceville, Georgia, United States, 30045 |
Investigational Site Number 840417 | Roswell, Georgia, United States, 30076 |
Investigational Site Number 840403 | Lexington, Kentucky, United States, 40504 |
Investigational Site Number 840404 | Hyattsville, Maryland, United States, 20782 |
Investigational Site Number 840405 | Rockville, Maryland, United States, 20852 |
Investigational Site Number 840411 | Las Vegas, Nevada, United States, 89148 |
Investigational Site Number 840415 | West Seneca, New York, United States, 14224 |
Investigational Site Number 840402 | Norman, Oklahoma, United States, 73069 |
Investigational Site Number 840407 | Medford, Oregon, United States, 97504 |
Investigational Site Number 840413 | Durham, Pennsylvania, United States, 27713 |
Investigational Site Number 840410 | Dallas, Texas, United States, 75230 |
Investigational Site Number 840414 | Renton, Washington, United States, 98055 |
Investigational Site Number 152401 | Santiago, Chile, 7980378 |
Investigational Site Number 152402 | Santiago, Chile, 8320000 |
Investigational Site Number 152404 | Santiago, Chile, 7500347 |
Investigational Site Number 152403 | Santiago, Chile, 7500710 |
Investigational Site Number 152405 | Santiago, Chile, 7500347 |
Investigational Site Number 203403 | Novy Jicin, Czech Republic, 74101 |
Investigational Site Number 203401 | Plzen, Czech Republic, 32600 |
Investigational Site Number 203402 | Praha 2, Czech Republic, 12808 |
Investigational Site Number 203405 | Praha 8, Czech Republic, 18100 |
Investigational Site Number 208401 | København Nv, Denmark, 2400 |
Investigational Site Number 208404 | Køge, Denmark, 4600 |
Investigational Site Number 208402 | Slagelse, Denmark, 4200 |
Investigational Site Number 208403 | Svendborg, Denmark, 5700 |
Investigational Site Number 250402 | Narbonne, France, 11018 |
Investigational Site Number 250404 | Poitiers Cedex, France, 86021 |
Investigational Site Number 250401 | Vandoeuvre Les Nancy, France, 54511 |
Investigational Site Number 276401 | Dresden, Germany, 01307 |
Investigational Site Number 276402 | Ludwigshafen, Germany, 67059 |
Investigational Site Number 276403 | Oberhausen, Germany, 46045 |
Investigational Site Number 348401 | Balatonfüred, Hungary, 8230 |
Investigational Site Number 348405 | Budapest, Hungary, 1041 |
Investigational Site Number 348406 | Budapest, Hungary, 1212 |
Investigational Site Number 348404 | Debrecen, Hungary, 4043 |
Investigational Site Number 348403 | Szeged, Hungary, 6722 |
Investigational Site Number 348402 | Szeged, Hungary, 6720 |
Investigational Site Number 440401 | Kaunas, Lithuania, LT-49456 |
Investigational Site Number 440402 | Kaunas, Lithuania, LT-51270 |
Investigational Site Number 440403 | Kedainiai, Lithuania, LT-57164 |
Investigational Site Number 440404 | Klaipeda, Lithuania, LT-92304 |
Investigational Site Number 484404 | Acapulco, Mexico, 39670 |
Investigational Site Number 484401 | Cuernavaca, Mexico, 62250 |
Investigational Site Number 484405 | Durango, Mexico, 34270 |
Investigational Site Number 484403 | Guadalajara, Mexico, 44656 |
Investigational Site Number 484402 | Guadalajara, Mexico, 44210 |
Investigational Site Number 616405 | Bialystok, Poland, 15-435 |
Investigational Site Number 616406 | Gdansk, Poland, 80-847 |
Investigational Site Number 616403 | Krakow, Poland, 31-548 |
Investigational Site Number 616407 | Lodz, Poland, 94-074 |
Investigational Site Number 616404 | Pulawy, Poland, 24-100 |
Investigational Site Number 616402 | Szczecin, Poland, 70-506 |
Investigational Site Number 616401 | Warszawa, Poland, 02-507 |
Investigational Site Number 642402 | Brasov, Romania, 500365 |
Investigational Site Number 642403 | Bucuresti, Romania, 020475 |
Investigational Site Number 642405 | Iasi, Romania, 700547 |
Investigational Site Number 642401 | Oradea, Romania, 410169 |
Investigational Site Number 642406 | Targu Mures, Romania, 540142 |
Investigational Site Number 642404 | Timisoara, Romania, 300133 |
Investigational Site Number 703402 | Bratislava, Slovakia, 85101 |
Investigational Site Number 703403 | Kosice, Slovakia, 04001 |
Investigational Site Number 703406 | Kosice, Slovakia, 04013 |
Investigational Site Number 703404 | Moldava Nad Bodvou, Slovakia, 04525 |
Investigational Site Number 703405 | Nitra, Slovakia, 94911 |
Investigational Site Number 703401 | Zilina, Slovakia, 01001 |
Investigational Site Number 752402 | Skellefteå, Sweden, 931 32 |
Investigational Site Number 752401 | Stockholm, Sweden, 171 76 |
Investigational Site Number 752403 | Växjö, Sweden, 351 85 |