Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients (GetGoal Duo-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01768559
First received: January 11, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

Primary Objective:

- To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

- To compare the treatments/regimens on:

  • The percentage of patients reaching the target of HbA1c <7% or ≤6.5%
  • Body weight
  • Self-Monitored Glucose profiles
  • Fasting Plasma Glucose (FPG)
  • Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients)
  • Daily doses of insulins
  • Safety and tolerability

Condition Intervention Phase
Type 2 Diabetes
Drug: lixisenatide (AVE0010)
Drug: insulin glulisine (HMR1964)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients reaching HbA1c <7% [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c ≤6.5% [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change in body weight from baseline [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Percentage of patients with no weight gain [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change in 7-point SMPG profiles from baseline [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in FPG [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in post-prandial glucose /glucose excursions during a standardized meal test (subset of patients) [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in insulin glargine dose [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Daily dose of insulin glulisine [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Total daily dose of insulin [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year) [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Severe hypoglycemia [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 855
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lixisenatide
lixisenatide once a day (injected before breakfast or dinner) on top of insulin glargine with or without metformin. Starting dose will be 10µg, then increased to the 20µg maintenance dose after 2 weeks
Drug: lixisenatide (AVE0010)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Active Comparator: insulin glulisine once a day
Insulin glulisine once a day (injected before breakfast or dinner) on top of insulin glargine with or without metformin. Treatment will be initiated and then individually titrated
Drug: insulin glulisine (HMR1964)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Other Name: Apidra©
Active Comparator: insulin glulisine three times a day
Insulin glulisine three times a day (injected before breakfast, lunch and dinner) on top of insulin glargine with or without metformin. Treatment will be initiated and then individually titrated
Drug: insulin glulisine (HMR1964)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Other Name: Apidra©

Detailed Description:

Approximately 41 weeks including a 26 week 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 at least 1 year before screening visit (V1) .
  • Patients treated with basal insulin for at least 6 months.
  • Patients treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (ie type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20 %) and ≥20 U/day for at least 2 months prior to visit 1.
  • Patients treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that can be: metformin (≥1.5g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.

Exclusion criteria:

  • At screening: age < legal age of majority
  • At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for patients treated with basal insulin and a combination of oral anti-diabetic drugs which includes a SU and/or a DPP-4 inhibitor and/or a glinide.
  • Women of childbearing potential with no effective contraceptive method, pregnancy or lactation
  • Type 1 diabetes mellitus
  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.
  • Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
  • Any previous treatment with lixisenatide, or any discontinuation from another GLP-1 receptor agonist due to safety/tolerability issue or lack of efficacy.
  • At screening, Body Mass Index (BMI) ≤20 or >40 kg/m².
  • Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
  • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
  • At screening resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 95 mmHg
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
  • Contraindication related to metformin (for patient receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
  • Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
  • At screening, amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN)
  • At screening ALT or AST>3ULN
  • At screening calcitonin ≥20 pg/ml (5.9 pmol/L)

Exclusion Criteria for randomization at the end of the screening period before randomization:

  • HbA1c <7.0% or >9.0%.
  • 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).
  • Amylase and/or lipase > 3 times ULN.

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: NCT01768559

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Hide Study Locations
Locations
United States, Arizona
Investigational Site Number 840043 Active, not recruiting
Sun City, Arizona, United States, 85351
Investigational Site Number 840042 Active, not recruiting
Tempe, Arizona, United States, 85282
United States, Arkansas
Investigational Site Number 840003 Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 840031 Completed
La Mesa, California, United States, 91942
Investigational Site Number 840005 Completed
Mission Viejo, California, United States, 92691
Investigational Site Number 840057 Active, not recruiting
Northridge, California, United States, 91325
Investigational Site Number 840035 Completed
Santa Ana, California, United States, 92704
Investigational Site Number 840002 Active, not recruiting
Temecula, California, United States, 92591
Investigational Site Number 840037 Completed
Walnut Creek, California, United States, 94598
Investigational Site Number 840023 Active, not recruiting
West Hills, California, United States, 91345
United States, Colorado
Investigational Site Number 840041 Active, not recruiting
Denver, Colorado, United States, 80246
United States, Florida
Investigational Site Number 840014 Recruiting
Hollywood, Florida, United States, 33021
Investigational Site Number 840012 Active, not recruiting
Miami, Florida, United States, 33136
Investigational Site Number 840061 Completed
Miami, Florida, United States, 33142
United States, Georgia
Investigational Site Number 840045 Active, not recruiting
Lawrenceville, Georgia, United States, 30045
United States, Idaho
Investigational Site Number 840036 Active, not recruiting
Nampa, Idaho, United States, 83686
United States, Illinois
Investigational Site Number 840024 Completed
Chicago, Illinois, United States, 60611
Investigational Site Number 840009 Active, not recruiting
Evanston, Illinois, United States, 60201
United States, Indiana
Investigational Site Number 840004 Active, not recruiting
Avon, Indiana, United States, 46123
Investigational Site Number 840055 Active, not recruiting
Avon, Indiana, United States, 46123
United States, Iowa
Investigational Site Number 840027 Active, not recruiting
Des Moines, Iowa, United States, 50314
United States, Kansas
Investigational Site Number 840006 Completed
Wichita, Kansas, United States, 67203
United States, Kentucky
Investigational Site Number 840047 Active, not recruiting
Lexington, Kentucky, United States, 40504
Investigational Site Number 840056 Active, not recruiting
Paducah, Kentucky, United States, 42003
United States, Louisiana
Investigational Site Number 840022 Active, not recruiting
Marrero, Louisiana, United States, 70072
United States, Maryland
Investigational Site Number 840016 Active, not recruiting
Baltimore, Maryland, United States, 21237
Investigational Site Number 840017 Active, not recruiting
Rockville, Maryland, United States, 20852
United States, Michigan
Investigational Site Number 840025 Completed
Buckley, Michigan, United States, 49620
Investigational Site Number 840048 Active, not recruiting
Dearborn, Michigan, United States, 48124
Investigational Site Number 840026 Completed
Kalamazoo, Michigan, United States, 49048
United States, Nevada
Investigational Site Number 840049 Active, not recruiting
Las Vegas, Nevada, United States, 89148
United States, New York
Investigational Site Number 840029 Active, not recruiting
New Hyde Park, New York, United States, 11042
Investigational Site Number 840060 Completed
Smithtown, New York, United States, 11787
Investigational Site Number 840030 Completed
Staten Island, New York, United States, 10301-3914
United States, North Carolina
Investigational Site Number 840011 Recruiting
Salisbury, North Carolina, United States, 28144
United States, North Dakota
Investigational Site Number 840028 Completed
Fargo, North Dakota, United States, 58103
United States, Oklahoma
Investigational Site Number 840007 Completed
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Investigational Site Number 840021 Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Investigational Site Number 840052 Active, not recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Investigational Site Number 840032 Completed
Chattanooga, Tennessee, United States, 37404
Investigational Site Number 840033 Completed
Nashville, Tennessee, United States, 37232
United States, Texas
Investigational Site Number 840034 Active, not recruiting
Corpus Christi, Texas, United States, 78404
Investigational Site Number 840001 Active, not recruiting
Dallas, Texas, United States, 75230
Investigational Site Number 840020 Active, not recruiting
Houston, Texas, United States, 77081
United States, Virginia
Investigational Site Number 840018 Completed
Norfolk, Virginia, United States, 23502
Investigational Site Number 840019 Recruiting
Norfolk, Virginia, United States, 23510
Investigational Site Number 840015 Active, not recruiting
Salem, Virginia, United States, 24153
United States, Wisconsin
Investigational Site Number 840010 Active, not recruiting
Milwaukee, Wisconsin, United States, 53217
Canada
Investigational Site Number 124008 Active, not recruiting
Brampton, Canada, L6R 3J5
Investigational Site Number 124015 Active, not recruiting
Burlington, Canada, L7M 4Y1
Investigational Site Number 124018 Active, not recruiting
Chatham, Canada, N7L 1C1
Investigational Site Number 124004 Active, not recruiting
Coquitlam, Canada, V3K 3P4
Investigational Site Number 124016 Active, not recruiting
Etobicoke, Canada, M9R 4E1
Investigational Site Number 124014 Active, not recruiting
Hamilton, Canada, L8L 5G8
Investigational Site Number 124020 Active, not recruiting
Montreal, Canada, H1Y 3L1
Investigational Site Number 124011 Active, not recruiting
Montreal, Canada, H3A 1A1
Investigational Site Number 124017 Completed
Newmarket, Canada, L3Y 5G8
Investigational Site Number 124021 Active, not recruiting
Quebec, Canada, G1N 4V3
Investigational Site Number 124003 Active, not recruiting
Red Deer, Canada, T4N 6V7
Investigational Site Number 124002 Active, not recruiting
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 124012 Completed
St-Romuald, Canada, G6W 5M6
Investigational Site Number 124010 Active, not recruiting
Toronto, Canada, M5C 2T2
Investigational Site Number 124001 Active, not recruiting
Toronto, Canada, M4G 3E8
Investigational Site Number 124005 Active, not recruiting
Vancouver, Canada, V5Z 1M9
Investigational Site Number 124006 Active, not recruiting
Victoria, Canada, V8V 4A1
Investigational Site Number 124007 Completed
Winnipeg, Canada, R3E 3P4
Chile
Investigational Site Number 152102 Active, not recruiting
Santiago, Chile, 7980378
Investigational Site Number 152101 Active, not recruiting
Santiago, Chile, 7500710
Investigational Site Number 152105 Active, not recruiting
Santiago, Chile, 7591047
Investigational Site Number 152103 Active, not recruiting
Santiago, Chile, 7500010
Investigational Site Number 152107 Active, not recruiting
Santiago, Chile, 7500347
Investigational Site Number 152109 Active, not recruiting
Santiago, Chile
Investigational Site Number 152108 Active, not recruiting
Santiago, Chile, 8053095
Investigational Site Number 152106 Completed
Santiago, Chile, 8053095
Czech Republic
Investigational Site Number 203107 Active, not recruiting
Beroun, Czech Republic, 26601
Investigational Site Number 203103 Active, not recruiting
Jilove U Prahy, Czech Republic, 254 01
Investigational Site Number 203101 Active, not recruiting
Ostrava 2, Czech Republic, 702 00
Investigational Site Number 203110 Active, not recruiting
Police Nad Metuji, Czech Republic, 549 54
Investigational Site Number 203102 Active, not recruiting
Praha 4, Czech Republic, 148 00
Investigational Site Number 203108 Active, not recruiting
Praha 4, Czech Republic, 14900
Investigational Site Number 203105 Active, not recruiting
Praha 4, Czech Republic, 14021
Investigational Site Number 203104 Active, not recruiting
Trutnov, Czech Republic, 54101
Estonia
Investigational Site Number 233102 Active, not recruiting
Pärnu, Estonia, 80018
Investigational Site Number 233103 Active, not recruiting
Tallinn, Estonia, 13415
Investigational Site Number 233104 Active, not recruiting
Tallinn, Estonia, 13419
Investigational Site Number 233101 Active, not recruiting
Viljandimaa, Estonia, 71024
France
Investigational Site Number 250108 Completed
Bois Guillaume, France, 76230
Investigational Site Number 250107 Active, not recruiting
Brest, France, 29100
Investigational Site Number 250105 Active, not recruiting
Corbeil Essonnes, France, 91108
Investigational Site Number 250104 Active, not recruiting
La Rochelle Cedex, France, 17019
Investigational Site Number 250106 Active, not recruiting
Lyon, France, 69495
Investigational Site Number 250109 Active, not recruiting
Mantes La Jolie, France, 78200
Investigational Site Number 250110 Recruiting
Montpellier, France, 34059
Investigational Site Number 250102 Active, not recruiting
Paris Cedex 15, France, 75908
Investigational Site Number 250101 Active, not recruiting
Vandoeuvre Les Nancy, France, 54511
Investigational Site Number 250103 Active, not recruiting
Venissieux, France, 69200
Germany
Investigational Site Number 276112 Active, not recruiting
Bad Mergentheim, Germany, 97980
Investigational Site Number 276108 Active, not recruiting
Berlin, Germany, 13125
Investigational Site Number 276102 Active, not recruiting
Dortmund, Germany, 44137
Investigational Site Number 276106 Active, not recruiting
Dresden, Germany, 01307
Investigational Site Number 276120 Active, not recruiting
Dresden, Germany, 01067
Investigational Site Number 276117 Active, not recruiting
Frankfurt A.M., Germany, 60596
Investigational Site Number 276116 Active, not recruiting
Görlitz, Germany, 02826
Investigational Site Number 276113 Active, not recruiting
Heidelberg, Germany, 69115
Investigational Site Number 276118 Completed
Leipzig, Germany, 04103
Investigational Site Number 276119 Completed
Magdeburg, Germany, 39104
Investigational Site Number 276103 Active, not recruiting
Neumünster, Germany, 24534
Investigational Site Number 276115 Completed
Speyer, Germany, 67346
Investigational Site Number 276109 Completed
St. Ingbert-Oberwürzbach, Germany, 66386
Hungary
Investigational Site Number 348108 Active, not recruiting
Budapest, Hungary, 1138
Investigational Site Number 348107 Active, not recruiting
Budapest, Hungary, 1134
Investigational Site Number 348102 Active, not recruiting
Budapest, Hungary, 1139
Investigational Site Number 348101 Active, not recruiting
Eger, Hungary, 3300
Investigational Site Number 348103 Active, not recruiting
Pápa, Hungary, 8500
Investigational Site Number 348104 Active, not recruiting
Szeged, Hungary, 6720
Investigational Site Number 348106 Active, not recruiting
Sátoraljaújhely, Hungary, 3980
Investigational Site Number 348105 Completed
Zalaegerszeg, Hungary, 8900
Italy
Investigational Site Number 380103 Active, not recruiting
Bologna, Italy, 40138
Investigational Site Number 380102 Active, not recruiting
Catania, Italy, 93124
Investigational Site Number 380101 Active, not recruiting
Milano, Italy, 20132
Investigational Site Number 380105 Active, not recruiting
Napoli, Italy, 80131
Investigational Site Number 380104 Active, not recruiting
Torino, Italy, 10126
Latvia
Investigational Site Number 428103 Active, not recruiting
Jelgava, Latvia, LV-3001
Investigational Site Number 428104 Active, not recruiting
Ogre, Latvia, LV-5001
Investigational Site Number 428102 Active, not recruiting
Riga, Latvia, LV-1002
Investigational Site Number 428105 Active, not recruiting
Riga, Latvia, LV-1006
Investigational Site Number 428101 Active, not recruiting
Sigulda, Latvia, LV-2150
Lithuania
Investigational Site Number 440104 Active, not recruiting
Jonava, Lithuania, LT-55201
Investigational Site Number 440102 Active, not recruiting
Kaunas, Lithuania, LT-49456
Investigational Site Number 440103 Active, not recruiting
Kaunas, Lithuania, LT-48259
Investigational Site Number 440101 Active, not recruiting
Kaunas, Lithuania, LT-51270
Investigational Site Number 440105 Completed
Klaipeda, Lithuania, LT-92288
Mexico
Investigational Site Number 484108 Active, not recruiting
Chihuahua, Mexico, 31200
Investigational Site Number 484101 Active, not recruiting
Cuernavaca, Mexico, 62250
Investigational Site Number 484111 Active, not recruiting
Durango, Mexico, 34270
Investigational Site Number 484104 Active, not recruiting
Guadalajara, Mexico, 44150
Investigational Site Number 484105 Active, not recruiting
Guadalajara, Mexico, 44650
Investigational Site Number 484110 Active, not recruiting
Guadalajara, Mexico, 44656
Investigational Site Number 484109 Active, not recruiting
Guadalajara, Mexico, 44210
Investigational Site Number 484107 Active, not recruiting
Guadalajara, Mexico, 44600
Investigational Site Number 484103 Active, not recruiting
Mexico Df, Mexico, 11850
Investigational Site Number 484106 Active, not recruiting
Monterrey, Mexico, 64000
Investigational Site Number 484102 Active, not recruiting
México, Mexico, 06700
Poland
Investigational Site Number 616101 Active, not recruiting
Bialystok, Poland, 15-435
Investigational Site Number 616103 Active, not recruiting
Bydgoszcz, Poland, 85-822
Investigational Site Number 616102 Active, not recruiting
Bytom, Poland, 41-902
Investigational Site Number 616106 Active, not recruiting
Krakow, Poland, 31-455
Investigational Site Number 616104 Active, not recruiting
Krakow, Poland, 31-548
Investigational Site Number 616105 Active, not recruiting
Pulawy, Poland, 24-100
Investigational Site Number 616107 Active, not recruiting
Warszawa, Poland, 02-507
Romania
Investigational Site Number 642105 Active, not recruiting
Bacau, Romania, 600114
Investigational Site Number 642108 Active, not recruiting
Cluj Napoca, Romania, 400006
Investigational Site Number 642106 Active, not recruiting
Deva, Romania, 330084
Investigational Site Number 642113 Active, not recruiting
Galati, Romania, 800098
Investigational Site Number 642107 Active, not recruiting
Hunedoara, Romania, 331057
Investigational Site Number 642117 Active, not recruiting
Iasi, Romania, 700547
Investigational Site Number 642103 Active, not recruiting
Oradea, Romania, 410169
Investigational Site Number 642104 Active, not recruiting
Oradea, Romania, 410169
Investigational Site Number 642112 Active, not recruiting
Pitesti, Romania, 110084
Investigational Site Number 642114 Active, not recruiting
Ploiesti, Romania, 100342
Investigational Site Number 642102 Completed
Resita, Romania, 320076
Investigational Site Number 642111 Active, not recruiting
Sibiu, Romania, 550371
Investigational Site Number 642110 Active, not recruiting
Targu Mures, Romania, 540142
Investigational Site Number 642109 Active, not recruiting
Targu Mures, Romania, 540142
Investigational Site Number 642115 Active, not recruiting
Timisoara, Romania, 300723
Investigational Site Number 642116 Active, not recruiting
Timisoara, Romania, 300133
Investigational Site Number 642101 Completed
Timisoara, Romania, 300456
Russian Federation
Investigational Site Number 643107 Active, not recruiting
Moscow, Russian Federation, 119991
Investigational Site Number 643105 Active, not recruiting
Moscow, Russian Federation, 129110
Investigational Site Number 643111 Active, not recruiting
Moscow, Russian Federation, 117036
Investigational Site Number 643110 Active, not recruiting
Penza, Russian Federation, 440026
Investigational Site Number 643102 Active, not recruiting
Saratov, Russian Federation, 410026
Investigational Site Number 643109 Active, not recruiting
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643104 Active, not recruiting
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643103 Active, not recruiting
St-Petersburg, Russian Federation, 195257
Investigational Site Number 643101 Active, not recruiting
St-Petersburg, Russian Federation, 194044
Investigational Site Number 643108 Active, not recruiting
St-Petersburg, Russian Federation, 195112
Investigational Site Number 643106 Active, not recruiting
St. Petersburg, Russian Federation, 194358
Spain
Investigational Site Number 724102 Active, not recruiting
El Ferrol, Spain, 15403
Investigational Site Number 724105 Completed
La Coruña, Spain, 15006
Investigational Site Number 724103 Active, not recruiting
Malaga, Spain, 29010
Investigational Site Number 724104 Active, not recruiting
Sevilla, Spain, 41010
Ukraine
Investigational Site Number 804104 Active, not recruiting
Chernivtsi, Ukraine, 58022
Investigational Site Number 804103 Completed
Donetsk, Ukraine, 83059
Investigational Site Number 804107 Active, not recruiting
Donetsk, Ukraine
Investigational Site Number 804108 Active, not recruiting
Mykolaiv, Ukraine, 54003
Investigational Site Number 804110 Active, not recruiting
Odessa, Ukraine, 65059
Investigational Site Number 804105 Active, not recruiting
Vinnytsya, Ukraine, 21001
Investigational Site Number 804102 Active, not recruiting
Vinnytsya, Ukraine, 21010
Investigational Site Number 804111 Active, not recruiting
Zaporozhie, Ukraine, 69600
United Kingdom
Investigational Site Number 826006 Active, not recruiting
Ashton-Under-Lyne, United Kingdom, OL6 9RW
Investigational Site Number 826002 Active, not recruiting
Birmingham, United Kingdom, B9 5SS
Investigational Site Number 826007 Completed
Carmarthen, United Kingdom, SA31 2AF
Investigational Site Number 826005 Active, not recruiting
Chester, United Kingdom, CH2 1UL
Investigational Site Number 826008 Active, not recruiting
Coventry, United Kingdom, CV1 4FH
Investigational Site Number 826009 Active, not recruiting
Dundee, United Kingdom, DD1 9SI
Investigational Site Number 826001 Active, not recruiting
Durham, United Kingdom, DH1 5TW
Investigational Site Number 826011 Active, not recruiting
Haddington, United Kingdom, EH41 3PF
Investigational Site Number 826012 Active, not recruiting
Leicester, United Kingdom, LE5 4PW
Investigational Site Number 826010 Completed
Plymouth, United Kingdom, PL6 8BX
Investigational Site Number 826004 Active, not recruiting
Sheffield, United Kingdom, S5 7AU
Investigational Site Number 826003 Active, not recruiting
St Helens, United Kingdom, WA93DA
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01768559     History of Changes
Other Study ID Numbers: EFC12626, 2012-004096-38, U1111-1131-4936
Study First Received: January 11, 2013
Last Updated: June 19, 2014
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
Glargine
Insulin glulisine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 09, 2014