24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine (GetGoal Duo1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00975286
First received: September 10, 2009
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment.

The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Lixisenatide (AVE0010)
Drug: Placebo
Drug: Insulin glargine
Device: Pen auto-injector
Drug: Metformin
Drug: Thiazolidinedione (TZD)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.


Secondary Outcome Measures:
  • Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Change From Baseline in Glucose Excursion at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Change From Baseline in Body Weight at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Change From Baseline in Average Insulin Glargine Daily Dose at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change was calculated by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change was calculated by subtracting baseline value from Wee 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Percentage of Patients Requiring Rescue Therapy During the Double-blind Period [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
    Routine fasting SMPG, central laboratory FPG and HbA1c values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG and HbA1c were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c >9%, from Week 8 to Week 24: fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.


Other Outcome Measures:
  • Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  • Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia [ Time Frame: First dose of study drug up to 3 days after the last dose administration ] [ Designated as safety issue: Yes ]
    Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.


Enrollment: 446
Study Start Date: October 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lixisenatide
2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Drug: Lixisenatide (AVE0010)
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Drug: Insulin glargine
Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.
Other Name: Lantus®
Device: Pen auto-injector
Lantus® SoloStar® OptiClik®
Drug: Metformin
Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.
Drug: Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.
Placebo Comparator: Placebo
2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Drug: Placebo
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Drug: Insulin glargine
Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.
Other Name: Lantus®
Device: Pen auto-injector
Lantus® SoloStar® OptiClik®
Drug: Metformin
Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.
Drug: Thiazolidinedione (TZD)
TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.

Detailed Description:

The study comprises 3 periods:

  • An up to 14-week screening period, which includes an up to 2-week screening phase and a 12-week run-in phase with introduction and titration of insulin glargine on top of metformin +/-TZDs.
  • At the end of the run-in phase, patients whose HbA1c (centralized assay) is greater than or equal to (>=) 7% and less than or equal to (<=) 9% and whose mean fasting self-monitored plasma glucose (SMPG) calculated from the self measurements for the 7 days prior to Visit 12 (Week -1) is <=140 milligram per deciliter (mg/dL) (7.8 millimole per liter [mmol/L]), would enter a 24-week double-blind randomized treatment period comparing lixisenatide to placebo (on top of insulin glargine + metformin +/- TZDs).
  • A 3-day safety follow up period.

Maximum duration is of 39 weeks +/- 7 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

- Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with insulin glargine and metformin

Exclusion criteria:

  • HbA1c <7% or greater than (>)10% at screening
  • At the time of screening age < legal age of majority
  • Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
  • Type 1 diabetes mellitus
  • Metformin not at a stable dose of at least 1.5 gram per day for at least 3 months prior to the screening visit
  • Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea (SU) and TZDs (for example, alpha glucosidase inhibitor, other glucagon like peptide-1 [GLP-1] receptor agonists, dipeptidyl peptidase-IV [DPP-IV] inhibitors, insulin etc.) within 3 months prior to the time of screening, use of weight loss drugs if not at a stable dose for at least 3 months prior to the screening visit
  • History of hypoglycemia unawareness
  • Body Mass Index (BMI) less than or equal to (<=) 20 kilogram per square meter (kg/m^2)
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (for example, multiple endocrine neoplasia syndromes)
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
  • Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion within 3 months prior to the time of screening
  • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
  • Known history of drug or alcohol abuse within 6 months prior to the time of screening
  • Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram or vital signs at the time of screening that in the judgment of the Investigator or any sub investigator precludes safe completion of the study or constrains efficacy assessment such as active malignant tumor or other major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period
  • Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure >180 millimeter of mercury (mmHg) or >110 mmHg, respectively
  • Laboratory findings at the time of screening: amylase and/or lipase, alanine aminotransferase >3 times upper limit of the normal (ULN) laboratory range; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody, positive serum pregnancy test in females of childbearing potential; and calcitonin >=20 picogram per milliliter (pg/mL) (5.9 picomole per milliliter [pmol/L])
  • Patients who are considered by the Investigator or any sub investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol, patient being investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol etc.)
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
  • Use of any investigational drug within 3 months prior to screening
  • Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men
  • History of hypersensitivity to insulin glargine or to any of the excipients
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (that is, worsening) and not controlled (that is, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
  • Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)
  • Allergic reaction to any GLP-1 receptor agonist in the past (for example, exenatide, liraglutide) or to metacresol
  • Additional exclusion criteria during or at the end of the run-in phase before randomization: informed consent withdrawal (patient who was not willing to continue or failed to return), mean fasting SMPG calculated from the self-measurements for the 7 days prior to Visit 12 (Week -1) was >140 mg/dL (7.8 mmol/L) and HbA1c measured at Visit 12 (Week -1) is <7% or >9%, amylase and/or lipase > 3 times the ULN at Visit 12 (Week -1), patients with fasting plasma glucose (FPG) above the threshold value described for rescue (that is, FPG >240 mg/dL [13.3 mmol/L]), patients with any adverse event, which, by the judgment of the Investigator precludes the inclusion in the double-blind randomized treatment phase, and lack of compliance to protocol or to insulin glargine treatment during the run-in phase
  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: NCT00975286

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Locations
United States, Arizona
Sanofi-Aventis Investigational Site Number 840223
Mesa, Arizona, United States, 85206
United States, Arkansas
Sanofi-Aventis Investigational Site Number 840206
Hot Springs, Arkansas, United States, 71913
Sanofi-Aventis Investigational Site Number 840201
Little Rock, Arkansas, United States, 72205
Sanofi-Aventis Investigational Site Number 840212
Mountain Home, Arkansas, United States, 72653
United States, California
Sanofi-Aventis Investigational Site Number 840215
Concord, California, United States, 94520
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Greenbrae, California, United States, 94904
United States, Florida
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Orlando, Florida, United States, 32835
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Rosario, Argentina, 2000
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Belem, Brazil, 66073-000
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Brasilia, Brazil, 71625-009
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Porto Alegre, Brazil, 90035001
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Sao Paulo, Brazil, 04024-002
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Santiago, Chile, 7980378
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Santiago, Chile, 8930211
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Santiago, Chile, 7500010
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Santiago, Chile, 8360156
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Bogota, Colombia
Czech Republic
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Praha 5, Czech Republic, 15006
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Frederiksberg, Denmark, 2000
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Slagelse, Denmark, 4200
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Tallinn, Estonia, 13415
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Tartu, Estonia, 50410
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Viljandimaa, Estonia, 71024
France
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Amiens Cedex 1, France, 80054
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La Rochelle Cedex, France, 17019
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Le Creusot, France, 71200
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Nantes, France, 44093
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Pierre Benite, France, 69310
Germany
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Dresden, Germany, 01307
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Mainz, Germany, 55116
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St. Ingbert-Oberwürzbach, Germany, 66386
Hungary
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Balatonfüred, Hungary, 8230
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Budapest, Hungary
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Budapest, Hungary, 1036
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Debrecen, Hungary, 4031
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Gyula, Hungary, 5700
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Szeged, Hungary, 6722
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Zalaegerszeg, Hungary, 8900
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Ahmedabad, India, 380015
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Bangalore, India, 560043
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Bangalore, India, 560052
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Nagpur, India, 440012
Israel
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Haifa, Israel, 31096
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Holon, Israel, 58100
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Kfar Saba, Israel, 44281
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Tel Hashomer, Israel, 52621
Italy
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Milano, Italy, 20132
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Perugia, Italy, 61260
Malaysia
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Kelantan, Malaysia, 16150
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Kuala Lumpur, Malaysia, 56000
Mexico
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Cuernavaca, Mexico, 62250
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Durango, Mexico, 34270
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Guadalajara, Mexico, 44600
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México City, Mexico, 14050
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Tlalnepantla, Mexico, 53160
Netherlands
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Amsterdam, Netherlands, 1066 EC
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Groningen, Netherlands, 9728 NT
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Zwijndrecht, Netherlands, 3331 LZ
Poland
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Krakow, Poland, 31-548
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Lubin, Poland, 59-300
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Plock, Poland, 09-400
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Pulawy, Poland, 24-100
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Sopot, Poland, 81-756
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Szczecin, Poland, 70-506
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Zabrze, Poland, 41-8--
Puerto Rico
Sanofi-Aventis Investigational Site Number 840226
Ponce, Puerto Rico, 00717
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San Juan, Puerto Rico, 00917
Romania
Sanofi-Aventis Investigational Site Number 642204
Brasov, Romania, 500326
Sanofi-Aventis Investigational Site Number 642208
Bucharest, Romania, 020725
Sanofi-Aventis Investigational Site Number 642205
Deva, Romania, 330084
Sanofi-Aventis Investigational Site Number 642203
Iasi, Romania, 700515
Sanofi-Aventis Investigational Site Number 642202
Oradea, Romania, 410598
Sanofi-Aventis Investigational Site Number 642206
Targu Mures, Romania, 540061
Sanofi-Aventis Investigational Site Number 642207
Timisoara, Romania, 300456
Sanofi-Aventis Investigational Site Number 642201
Timisoara, Romania, 300593
Russian Federation
Sanofi-Aventis Investigational Site Number 643203
Saratov, Russian Federation, 410030
Sanofi-Aventis Investigational Site Number 643202
St. Petersburg, Russian Federation, 194358
South Africa
Sanofi-Aventis Investigational Site Number 710202
Cape Town, South Africa, 7708
Sanofi-Aventis Investigational Site Number 710201
Durban, South Africa, 4092
Sanofi-Aventis Investigational Site Number 710203
Pretoria, South Africa
Sweden
Sanofi-Aventis Investigational Site Number 752204
Göteborg, Sweden, 413 45
Sanofi-Aventis Investigational Site Number 752203
Härnösand, Sweden, 871 82
Sanofi-Aventis Investigational Site Number 752205
Luleå, Sweden, 972 33
Sanofi-Aventis Investigational Site Number 752202
Malmö, Sweden, 211 52
Sanofi-Aventis Investigational Site Number 752201
Stockholm, Sweden, 111 57
Taiwan
Sanofi-Aventis Investigational Site Number 158204
Changhua, Taiwan, 500
Sanofi-Aventis Investigational Site Number 158203
Taichung, Taiwan, 433
Sanofi-Aventis Investigational Site Number 158201
Taichung R.O.C., Taiwan, 407
Sanofi-Aventis Investigational Site Number 158202
Tainan Hsien, Taiwan, 710
Ukraine
Sanofi-Aventis Investigational Site Number 804203
Chernivtsi, Ukraine, 58022
Sanofi-Aventis Investigational Site Number 804201
Kiev, Ukraine, 2091
Sanofi-Aventis Investigational Site Number 804202
Kyiv, Ukraine
Sanofi-Aventis Investigational Site Number 804205
Kyiv, Ukraine, 31156
Sanofi-Aventis Investigational Site Number 804204
Vinnytsya, Ukraine, 21010
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Study Operations Sanofi
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00975286     History of Changes
Other Study ID Numbers: EFC10781, EudraCT : 2008-007335-40
Study First Received: September 10, 2009
Last Updated: April 9, 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
2,4-thiazolidinedione
Glargine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014