24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00976937
First received: September 14, 2009
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index [BMI] greater than or equal to 30 kilogram per square meter [kg/m^2]) type 2 diabetic patients less than 50 years of age, over a period of 24 weeks of treatment.

The primary objective of this study is to assess the efficacy of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24.

Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on absolute changes in HbA1c values and body weight; fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and anti-lixisenatide antibody development.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Lixisenatide (AVE0010)
Drug: Lixisenatide Placebo
Device: Pen auto-injector
Drug: Sitagliptin
Drug: Sitagliptin Placebo
Drug: Metformin
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, Double-blind, Double-dummy, 2-arm Parallel-group, Multicenter 24-week Study Comparing the Efficacy and Safety of AVE0010 to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 and Not Adequately Controlled With Metformin

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentage of patients who met both criteria (HbA1c <7% at Week 24 and at least 5% weight loss from baseline at Week 24) is reported. 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.


Secondary Outcome Measures:
  • Absolute Change From Baseline in 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 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.

  • 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.

  • 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 the study drug or up to the introduction of rescue therapy, whichever is the earliest.

  • 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 Week 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.

  • 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 the study drug or up to the introduction of rescue therapy, whichever is the earliest.

  • Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change was calculated for fasting plasma insulin and 2-hour post prandial plasma insulin 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 the study drug or up to the introduction of rescue therapy, whichever is the earliest.

  • Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change was calculated for fasting C-peptide and 2-hour postprandial C-peptide 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.

  • Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change was calculated for fasting glucagon and 2-hour postprandial glucagon 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.

  • Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    Change was calculated for fasting proinsulin and 2-hour postprandial proinsulin 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 the study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.

  • Change From Baseline in Insulin Resistance Assessed by Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    HOMA-IR was derived from FPG and FPI as: (FPI [micro units per milliliter]*FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-IR 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.

  • Change From Baseline in Beta Cell Function Assessed by Homeostasis Model Assessment-Beta (HOMA-beta) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    HOMA-beta was derived from FPG and FPI as: (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta 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.

  • 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 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.

  • Percentage of Patients Requiring Rescue Therapy During 24-Week Period [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
    Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) 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 after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%.


Other Outcome Measures:
  • 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 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.

  • 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.

  • Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio 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 the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.

  • 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: 319
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lixisenatide
2-step initiation regimen of lixisenatide along with sitagliptin placebo: 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 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24.
Drug: Lixisenatide (AVE0010)
Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
Device: Pen auto-injector
Other Name: OptiClik®
Drug: Sitagliptin Placebo
Administered orally once a day in the morning with or without food at approximately the same time each day.
Drug: Metformin
Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.
Active Comparator: Sitagliptin
Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Drug: Lixisenatide Placebo
Self-administered by subcutaneous injections once daily within the hour preceding breakfast.
Device: Pen auto-injector
Other Name: OptiClik®
Drug: Sitagliptin
Administered orally once a day in the morning with or without food at approximately the same time each day.
Other Name: Januvia®
Drug: Metformin
Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 gram/day (g/day) for at least 3 months prior to the screening visit
  • Patients with obesity (BMI greater than equal to [>=] 30 kg/m^2) and aged from 18 years to less than 50 years

Exclusion criteria

  • HbA1c less than (<) 7.0 percent (%) or HbA1c greater than (>) 10% at screening
  • Type 1 diabetes mellitus
  • Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
  • FPG at screening >250 milligram/deciliter (mg/dL) (>13.9 millimole/ liter [mmol/L])
  • Weight change of more than 5 kg during the 3 months preceding the screening visit
  • 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 or receipt of blood or plasma products 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 (ECG) or vital signs at the time of screening that in the judgment of the investigator or any sub-investigator could have precludes safe completion of the study or constrains efficacy assessment such as 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 >3 times the upper limit of normal (ULN) laboratory range; alanine aminotransferase (ALT): >3 times ULN; 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 (HBsAg) and/or Hepatitis C antibody (HCAb), positive serum pregnancy test in females of childbearing potential, and calcitonin >=20 picogram per milliliter (pg/mL) (5.9 picomole per liter)
  • Patients who are considered by the investigator or any sub-investigator as inappropriate for the 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, investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)
  • Use of other oral or injectable antidiabetic or hypoglycemic agents than metformin (for example, sulfonylurea, alpha glucosidase inhibitor, thiazolidinedione, exenatide, dipeptidyl peptidase IV (DPP-IV) inhibitors, insulin) within 3 months prior to the time of screening
  • History of bariatric surgery, anti-obesity treatment, or unstable diet within 3 months prior to the time of screening
  • 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
  • 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 glucagon like peptide-1 (GLP 1) agonist in the past (for example, exenatide, liraglutide) or to metacresol
  • History of a serious hypersensitivity reaction to sitagliptin
  • Moderate or severe renal impairment (creatinine clearance inferior to 50 milliliter/minute [mL/min])
  • Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in period (>2 injections missed or >2 capsules missed); and patient with any adverse event which could have precludes the inclusion in the study, as assessed by the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976937

  Hide Study Locations
Locations
United States, Alabama
Sanofi-Aventis Investigational Site Number 840019
Montgomery, Alabama, United States, 36109
Sanofi-Aventis Investigational Site Number 840003
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Sanofi-Aventis Investigational Site Number 840022
Mesa, Arizona, United States, 85206
United States, California
Sanofi-Aventis Investigational Site Number 840011
Anaheim, California, United States, 92801
Sanofi-Aventis Investigational Site Number 840014
Paramount, California, United States, 90723
Sanofi-Aventis Investigational Site Number 840027
Redlands, California, United States, 92374
United States, Georgia
Sanofi-Aventis Investigational Site Number 840021
Augusta, Georgia, United States, 30909
Sanofi-Aventis Investigational Site Number 840007
Roswell, Georgia, United States, 30076
United States, Illinois
Sanofi-Aventis Investigational Site Number 840018
Chicago, Illinois, United States, 60616
Sanofi-Aventis Investigational Site Number 840016
Chicago, Illinois, United States, 60610
United States, Indiana
Sanofi-Aventis Investigational Site Number 840001
Evansville, Indiana, United States, 47714
United States, Louisiana
Sanofi-Aventis Investigational Site Number 840002
Baton Rouge, Louisiana, United States, 70808
United States, Michigan
Sanofi-Aventis Investigational Site Number 840031
Clarkston, Michigan, United States, 48346
United States, Missouri
Sanofi-Aventis Investigational Site Number 840020
Florissant, Missouri, United States, 63031
United States, Montana
Sanofi-Aventis Investigational Site Number 840006
Butte, Montana, United States, 59701
United States, Ohio
Sanofi-Aventis Investigational Site Number 840026
Perrysburg, Ohio, United States, 43551
United States, Oregon
Sanofi-Aventis Investigational Site Number 840004
Medford, Oregon, United States, 97504
United States, Pennsylvania
Sanofi-Aventis Investigational Site Number 840025
Altoona, Pennsylvania, United States, 16602
United States, Tennessee
Sanofi-Aventis Investigational Site Number 840009
Brentwood, Tennessee, United States, 37207
United States, Texas
Sanofi-Aventis Investigational Site Number 840008
Dallas, Texas, United States, 75230
Sanofi-Aventis Investigational Site Number 840010
San Antonio, Texas, United States, 78229
Australia
Sanofi-Aventis Investigational Site Number 036006
Adelaide, Australia, 5000
Sanofi-Aventis Investigational Site Number 036001
Box Hill, Australia, 3128
Sanofi-Aventis Investigational Site Number 036004
Elizabeth Vale, Australia, 5112
Sanofi-Aventis Investigational Site Number 036002
Geelong, Australia, 3220
Sanofi-Aventis Investigational Site Number 036005
Meadowbrook, Australia, 4131
Sanofi-Aventis Investigational Site Number 036003
Sydney, Australia, 2006
Brazil
Sanofi-Aventis Investigational Site Number 076005
Belem, Brazil, 66073-000
Sanofi-Aventis Investigational Site Number 076001
Brasilia, Brazil, 71625-009
Sanofi-Aventis Investigational Site Number 076006
Caxias Do Sul, Brazil, 95070-560
Sanofi-Aventis Investigational Site Number 076003
Curitiba, Brazil, 80060-900
Sanofi-Aventis Investigational Site Number 076002
Rio De Janeiro, Brazil, 20211-340
Sanofi-Aventis Investigational Site Number 076007
Sao Paulo, Brazil, 05403-000
Sanofi-Aventis Investigational Site Number 076004
Sao Paulo, Brazil, 04024-002
Canada
Sanofi-Aventis Investigational Site Number 124004
Calgary, Canada, T2N 4N1
Sanofi-Aventis Investigational Site Number 124008
Hamilton, Canada, L8L 5G8
Sanofi-Aventis Investigational Site Number 124005
London, Canada, N6G 2M3
Sanofi-Aventis Investigational Site Number 124006
Montreal, Canada, H2W 1R7
Sanofi-Aventis Investigational Site Number 124013
Oakville, Canada, L6H 3P1
Sanofi-Aventis Investigational Site Number 124002
St-Romuald, Canada, G6W 5M6
Sanofi-Aventis Investigational Site Number 124012
Thornhill, Canada, L4J 8L7
Sanofi-Aventis Investigational Site Number 124011
Toronto, Canada
Sanofi-Aventis Investigational Site Number 124003
Vancouver, Canada, V5Z 1C6
Sanofi-Aventis Investigational Site Number 124007
Victoria, Canada, V8R 6V4
Chile
Sanofi-Aventis Investigational Site Number 152005
Santiago, Chile
Sanofi-Aventis Investigational Site Number 152002
Santiago, Chile
Sanofi-Aventis Investigational Site Number 152003
Santiago, Chile, 8053095
Sanofi-Aventis Investigational Site Number 152004
Santiago, Chile, 7500710
Sanofi-Aventis Investigational Site Number 152001
Santiago, Chile, 7500347
Germany
Sanofi-Aventis Investigational Site Number 276002
Berlin, Germany, 13125
Sanofi-Aventis Investigational Site Number 276005
Ludwigshafen, Germany, 67059
Sanofi-Aventis Investigational Site Number 276004
Schkeuditz, Germany, 04435
Guatemala
Sanofi-Aventis Investigational Site Number 320001
Guatemala, Guatemala, 01014
Sanofi-Aventis Investigational Site Number 320002
Guatemala, Guatemala, 01010
Sanofi-Aventis Investigational Site Number 320004
Guatemala, Guatemala, 1010
Sanofi-Aventis Investigational Site Number 320005
Guatemala, Guatemala
Sanofi-Aventis Investigational Site Number 320006
Guatemala, Guatemala
Mexico
Sanofi-Aventis Investigational Site Number 484003
Aguascalientes, Mexico, 20230
Sanofi-Aventis Investigational Site Number 484010
Chihuahua, Mexico, 31000
Sanofi-Aventis Investigational Site Number 484009
Chihuahua, Mexico, 31238
Sanofi-Aventis Investigational Site Number 484012
Df, Mexico, 03300
Sanofi-Aventis Investigational Site Number 484008
Merida, Mexico, 97000
Sanofi-Aventis Investigational Site Number 484011
México City, Mexico, 14050
Sanofi-Aventis Investigational Site Number 484005
Pachuca, Mexico, 42090
Sanofi-Aventis Investigational Site Number 484001
Pachuca, Mexico, 42090
Sanofi-Aventis Investigational Site Number 484006
Veracruz, Mexico, 91700
Sanofi-Aventis Investigational Site Number 484002
Zapopan, Mexico, 44030
Peru
Sanofi-Aventis Investigational Site Number 604002
Lima, Peru
Sanofi-Aventis Investigational Site Number 604003
Lima, Peru, Lima 27
Sanofi-Aventis Investigational Site Number 604001
Lima, Peru
Sanofi-Aventis Investigational Site Number 604005
Lima, Peru, 27
Sanofi-Aventis Investigational Site Number 604004
Lima, Peru
Poland
Sanofi-Aventis Investigational Site Number 616002
Bialystok, Poland, 15-435
Sanofi-Aventis Investigational Site Number 616001
Bydgoszcz, Poland, 85-822
Sanofi-Aventis Investigational Site Number 616006
Warszawa, Poland, 02-507
Sanofi-Aventis Investigational Site Number 616003
Wroclaw, Poland, 50-127
Romania
Sanofi-Aventis Investigational Site Number 642004
Bacau, Romania, 600164
Sanofi-Aventis Investigational Site Number 642006
Bucuresti, Romania, 020475
Sanofi-Aventis Investigational Site Number 642008
Bucuresti, Romania, 022441
Sanofi-Aventis Investigational Site Number 642010
Iasi, Romania, 700515
Sanofi-Aventis Investigational Site Number 642009
Ploiesti, Romania, 100097
Sanofi-Aventis Investigational Site Number 642001
Resita, Romania, 320076
Sanofi-Aventis Investigational Site Number 642005
Suceava, Romania, 720262
Sanofi-Aventis Investigational Site Number 642007
Timisoara, Romania, 300593
Russian Federation
Sanofi-Aventis Investigational Site Number 643002
Kazan, Russian Federation, 420012
Sanofi-Aventis Investigational Site Number 643003
St-Petersburg, Russian Federation, 195257
Sanofi-Aventis Investigational Site Number 643005
St-Petersburg, Russian Federation, 198013
Sanofi-Aventis Investigational Site Number 643001
St. Petersburg, Russian Federation, 194358
Sanofi-Aventis Investigational Site Number 643004
Tyumen, Russian Federation, 625023
Ukraine
Sanofi-Aventis Investigational Site Number 804003
Chernivtsi, Ukraine, 58022
Sanofi-Aventis Investigational Site Number 804001
Kiev, Ukraine, 2091
Sanofi-Aventis Investigational Site Number 804004
Kyiv, Ukraine, 31156
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00976937     History of Changes
Other Study ID Numbers: EFC10780, EudraCT:2008-007 334-22
Study First Received: September 14, 2009
Last Updated: March 10, 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
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014