Clinical trial NCT00196989: Study In People With Type 2 Diabetes
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of Oral GW677954 as a Monotherapy for 12 Weeks Duration in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Efficacy
PPARpan
Type 2 Diabetes Mellitus
Phase IIb
Safety
Pharmacokinetics
GW677954
Pharmacodynamics
Tolerability
Dose-Ranging
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus).

Detailed description: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Study To Evaluate Efficacy, Safety And Tolerability Of Oral GW677954 Capsules (2.5, 5, 10, 15 And 20 Mg Once A Day) As A Monotherapy (Diet and/or exercise treated) Or As An Add-On To Metformin For 16 Weeks Duration In Subjects With Type 2 Diabetes Mellitus

Eligibility criteria: Inclusion criteria:

* Subjects with T2DM as defined by the criteria of the ADA and/or recognized by WHO Expert Committee on the Diagnosis and Classification of Diabetes Mellitus \[American Diabetes Association, 2004\], for at least 3 months preceding screening (see Section 15.3, Appendix 3:, "Diagnosis and Classification of Diabetes Mellitus").
* To be eligible for Randomization into the trial, a subject must satisfy all of the following glycemic criteria:

  * HbA1c level via central laboratory at the pre-screening visit
  * If HbA1c ≥ 8.0% but ≤ 10.0%: subject may proceed to Randomization;
  * If HbA1c ≥ 7.8% but \< 8.0%, subject not eligible to proceed, but may be retested once to establish eligibility (or lack thereof). If HbA1c level ≥ 8.0% upon retest, subject is eligible to proceed; otherwise they should be withdrawn.
  * If HbA1c \< 7.8%, subject not eligible to proceed (no retest allowed).
  * FPG level via central laboratory at the pre-screening visit must be \< 270 mg/dL (15.0 mmol/L). FPG may be retested within a week to confirm eligibility (or lack thereof).
* Concurrent T2DM therapy:

  * Diet and/or exercise treated: Must not have taken antidiabetic medication for at least 2 months prior to the pre-screening visit, OR
  * Metformin monotherapy: Subjects entering the study on metformin must be on the same dose, formulation and regimen of metformin for at least 2 months prior to the pre-screening visit, AND
  * TZDs and insulin are excluded in the 3 months prior to the Screening visit for all subjects.
* Males and females who are 18 to 70 years of age inclusive at the time of Screening.
* If female, eligible to enter and participate in this study:

  * If of non-childbearing potential (i.e., physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal \[\>1 year without menstrual period\]); or,
  * If of child-bearing potential, has a negative pregnancy test at Screening (serum), at Randomization (urine) and:

    * Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or
    * Uses double-barrier methods of contraception; condoms with the use of caps (with spermicide) and IUDs are acceptable, or
    * Uses hormonal contraceptives (oral, depots, patches etc) with double- barrier methods of contraception as outlined above, or
    * Abstains from sexual intercourse, or
    * Is with a same sex partner and does not participate in bisexual activities where there is any risk of pregnancy.
* Body Mass Index (BMI): ≥25 and ≤40 kg/m² and weigh at least 50 kg at Screening.
* If subject is a smoker, must be able to abstain while in clinic at each visit.
* Subject has given full written informed consent prior to any study related procedures are performed.

Exclusion criteria:

Exclusion Criteria:

* Metabolic Disease including:

  * Diagnosis of Type 1 diabetes mellitus
  * Uncorrected thyroid dysfunction. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 1 month prior to Screening, and who have a screening thyroid stimulating hormone (TSH) within the upper limit of normal may participate).
  * Significant weight gain or loss (defined as \> 5% of total body weight) within the 3 months prior to Screening.
* Previous use of insulin for treatment of hyperglycemia within 3 months of Screening.
* History of recent clinically significant cardiovascular disease including:

  * History or ECG evidence of prior myocardial infarction within 6 months prior to Screening.
  * Current unstable angina or history of unstable angina in past 6 months.
  * Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening.
  * Clinically significant arrhythmia or valvular heart disease.
  * Congestive heart failure (CHF) with New York Heart Association (NYHA) Class II-IV symptoms (see Section 15.4, Appendix 4).
  * Blood pressure \> 160/100 mmHg or resting heart rate \> 100 bpm. Note: subjects using antihypertensives \[e.g., beta blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers and diuretics\] must be on stable doses during the 30 days prior to Screening and during the trial.
  * Has a QTc interval (Bazett's) \> 440 msec in males and \> 450 msec in females at Screening.
  * Clinically significant ECG abnormalities which, in the opinion of the Investigator, may affect the interpretation of safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity.
* History of chronic pancreatitis.
* Familial hypercholesterolemia.
* TGs ≥800 mg/dL (8.96 mmol/L) at Screening.
* Serum creatinine at screening \> 1.4 mg/dL (124 µmol/L) for women, or \> 1.5 mg/dL (133 µmol/L) for men.
* Clinically significant anemia defined by hemoglobin concentrations \<12.0 g/dL or \< 120.0 g/L for males and \< 11.0 g/dL or \< 110.0 g/L for females.
* History of significant co-morbid diseases (e.g., cholelithiasis, gastrointestinal disease, etc.) that would preclude participation in the study.
* Documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody) at Screening, and/or clinically significant hepatic enzyme elevation including:

  •Any one of the following enzymes greater than 2.5 times the upper limit of normal (ULN) value at Screening:
  * Alanine aminotransferase (ALT)
  * Aspartate aminotransferase (AST)
  * Alkaline phosphatase (ALP)
  * Total or direct bilirubin \> 1.5 times the ULN at Screening, unless consistent with presumed or diagnosed Gilbert's disease.
* History of metabolic acidosis, rhabdomyolysis, myalgia, myositis or myopathy after taking statins or fibrates.
* Any subject who has withdrawn therapy due to AEs after taking a PPARγ or a PPARα/γ dual agonist, either marketed (e.g., troglitazone, rosiglitazone or pioglitazone) or under current or previous clinical investigation.
* Signs or symptoms of myositis at Screening (or upon 1 repeat test), and/or creatinine phosphokinase (CPK)≥3.0 times ULN
* Is currently taking or has taken any of the following medications in the 3 months prior to the pre-screening visit:

  * Anti-obesity agents (including fat absorption blocking agents)
  * St. John's Wort
  * Warfarin and other oral anticoagulants (excluding aspirin and non-steroidal anti-inflammatory drugs)
  * Digoxin
  * Oral or injectable corticosteroids (inhaled and intranasal steroids are acceptable)
  * Use of antidiabetic agents (other than metformin) in the 2 months prior to the pre-screening visit.
  * Use of TZDs in the 3 months prior to the pre-screening visit.
  * Methotrexate, cyclosporine or monoclonal antibodies (e.g., alemtuzumab, gemtuzumab ozogamicin, rituximab, trastuzumab, ibritumomab, tiuxetan) for rheumatoid arthritis or psoriasis.
  * Atypical antipsychotic medications \[e.g., aripiprazole (Abilify), risperidone (Risperdal), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), and ziprasidone (Geodon)\].
  * Antiretroviral drugs
  * Use of lipid lowering agents within 3 months prior to the pre-screening visit. This includes statins, fibrates, ezetimibe (Zetia), niacin and bile acid sequestrants.
  * Monoamine oxidase inhibitors
* History of cancer except for the following:

  * Basal cell carcinoma or superficial squamous cell carcinoma treated by local excision.
  * Cervical cancer in situ treated definitively more than 6 months prior to screening.
* Women who are lactating, pregnant, or planning to become pregnant.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to any drug chemically related to the study drug.
* Known allergy to any of the capsule excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation. Hypersensitivity to metformin or any of its components (for subjects entering on metformin).
* Has a history of substance and/or alcohol abuse within the past year as determined by the Investigator at screening or during treatment:

  * Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
  * History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
* Received treatment with a new molecular entity (investigational drug) during the previous 4 months or participated in any other trial during the previous 3 months, or has participated in a previous study with GW677954. A new molecular entity is defined as any compound not in Phase 3. (The washout is from last dose of investigational product in the previous study until the first dose of investigational product.)
* Likely to be non-compliant, in the investigator's opinion, with respect to the protocol and related scheduled visits.
* Subject has any concomitant medical condition which in the opinion of the investigator makes them unsuitable to participate in the study.
* Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.

Primary outcomes:
measure: Percentage change from Baseline (Day 1) in glycated hemoglobin (HbA1c) levels at Week 16 as a measure of improvement in glucose control
timeFrame: Week (W) 16
Secondary outcomes:
measure: Percentage change from Baseline (Day 1) in fasting HbA1c levels at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8, and 12
measure: Change from Baseline (Day 1) in fasting plasma glucose (FPG) at Weeks 1, 2, 4, 6, 8, 12 and 16
timeFrame: W1, W2, W4, W6, W8, W12, and W16
measure: Change from Baseline (Day 1) in fasting fructosamine at Weeks 2 and 4
timeFrame: Baseline (Day 1), W2, W4
measure: Percentage of participants achieving target HbA1c levels at Weeks 4, 8, 12, and 16
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of participants achieving a decrease in HbA1c of >= 0.7% from Baseline (Day 1) at Weeks 4, 8, 12 and 16
timeFrame: Baseline (Day 1), Weeks 4, 8, 12, and 16
measure: Percentage of participants achieving target range of FPG at Weeks 1, 2, 4, 6, 8, 12 and 16
timeFrame: Weeks 1,2, 4, 6, 8, 12, and 16
measure: Percentage of participants achieving a decrease from Baseline (Day 1) of >=30 mg/dL [1.66 mmol/L] in FPG at Weeks 1, 2, 4, 6, 8, 12 and 16
timeFrame: Weeks 1, 2, 4, 6, 8, 12, and 16
measure: Ratio to the Baseline (percentage change) of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and free fatty acids (FFA) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline (Day 1), Weeks 2, 4, 8, 12, and 16
measure: Percentage change from Baseline (Day 1) in non-HDL-C based on log-transformed data at Week 16
timeFrame: At Week 16
measure: Percentage change from Baseline (Day 1) in very low density lipoprotein-cholesterol (VLDL-C), apolipoprotein AI (Apo AI), AII, and B at Week 16.
timeFrame: At Week 16
measure: Change from Baseline (Day 1) in Apo B/TC, TC/HDL-C, and LDL-C/Apo B ratio at Week 16
timeFrame: At Week 16
measure: Change from Baseline (Day 1) in hemoglobin at Week 16
timeFrame: At Week 16
measure: Change from Baseline (Day 1) in hematocrit at Week 16
timeFrame: Wekk 16
measure: Change from Baseline (Day 1) in systolic and diastolic blood pressure (SBP and DBP) at Week 16
timeFrame: At Week 16
measure: Change from Baseline (Day 1) in heart rate at Week 16
timeFrame: Week 16
measure: Change from Baseline (Day 1) in body weight at Week 16
timeFrame: Week 16
measure: Change from Baseline (Day 1) in 12 lead electrocardiogram (ECG) measures including PR interval, QT interval, QTc interval and QRS duration at Week 16
timeFrame: Week 16
measure: Number of participants with clinical hematology, chemistry, urinalysis, exploratory cardiac parameters of potential clinical concern (PCC) along with serum pregnancy test over period
timeFrame: Upto 16 weeks
measure: Number of participants with hypoglycemic events as a measure of ophthalmic assessment
timeFrame: Up to 16 weeks
measure: Number of participants with intensity of hypoglycemic events as a measure of ophthalmic assessment
timeFrame: Up to 16 weeks
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) over period
timeFrame: Up to 16 weeks
measure: Change from Baseline (Day 1) in phosphocreatine kinase (Creatine kinase-MB) over period
timeFrame: Up to 16 weeks
measure: Number of participants with absolute Troponin-I (cTnI) levels over period
timeFrame: Up to 16 weeks
measure: Change from Baseline (Day 1) in fasting insulin at Week 8 and 16
timeFrame: Week 8 and 16
measure: Change from Baseline (Day 1) in C-peptide at Week 8 and 16
timeFrame: Week 8 and 16
measure: Change from Baseline (Day 1) in HOMA-S at Week 16
timeFrame: Week 16
measure: Change from Baseline (Day 1) in QUICKI at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Northport
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Alhambra
country: United States
facility: GSK Investigational Site
state: California
city: Artesia
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Inglewood
country: United States
facility: GSK Investigational Site
state: California
city: Irvine
country: United States
facility: GSK Investigational Site
state: California
city: LaJolla
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Northridge
country: United States
facility: GSK Investigational Site
state: California
city: Norwalk
country: United States
facility: GSK Investigational Site
state: California
city: Pasadena
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Santa Monica
country: United States
facility: GSK Investigational Site
state: California
city: Tustin
country: United States
facility: GSK Investigational Site
state: California
city: Vista
country: United States
facility: GSK Investigational Site
state: California
city: West Hills
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Norwich
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Largo
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: St. Cloud
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Duluth
country: United States
facility: GSK Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Springfield
country: United States
facility: GSK Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: West Yarmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Henderson
country: United States
facility: GSK Investigational Site
state: Nevada
city: Henderson
country: United States
facility: GSK Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Pahrump
country: United States
facility: GSK Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Santa Fe
country: United States
facility: GSK Investigational Site
state: New Mexico
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Franklin
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Cite
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Tyler
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Virginia Beach
country: United States
facility: GSK Investigational Site
state: Virginia
city: Edmonds
country: United States
facility: GSK Investigational Site
state: Washington
city: Everett
country: United States
facility: GSK Investigational Site
state: Washington
city: Monroe
country: United States
facility: GSK Investigational Site
state: Washington
city: Wauwatosa
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: San Juan
country: Argentina
facility: GSK Investigational Site
city: Miranda
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Carina Heights
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Spring Hill
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Keswick
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Port Lincoln
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Ringwood East
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Langley
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Saint John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Smiths Falls
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Bonaventure
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Granby
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Laval
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Longueuil
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Saint Marc Des Carrieres
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Bogotá
country: Colombia
facility: GSK Investigational Site
city: San José
country: Costa Rica
facility: GSK Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: GSK Investigational Site
city: Cheb
country: Czech Republic
facility: GSK Investigational Site
city: Olomouc
country: Czech Republic
facility: GSK Investigational Site
city: Praha 10
country: Czech Republic
facility: GSK Investigational Site
city: Praha 2
country: Czech Republic
facility: GSK Investigational Site
city: Praha 5
country: Czech Republic
facility: GSK Investigational Site
city: Praha 5
country: Czech Republic
facility: GSK Investigational Site
city: Quito
country: Ecuador
facility: GSK Investigational Site
city: Cesis
country: Latvia
facility: GSK Investigational Site
city: Daugavpils
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Tukums
country: Latvia
facility: GSK Investigational Site
city: Tijuana
country: Mexico
facility: GSK Investigational Site
state: Baja California Norte
city: Pachuca
country: Mexico
facility: GSK Investigational Site
state: Hidalgo
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Rotorua
country: New Zealand
facility: GSK Investigational Site
city: Tauranga
country: New Zealand
facility: GSK Investigational Site
city: San Isidro
country: Peru
facility: GSK Investigational Site
state: Lima
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Perm
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: Tumen
country: Russian Federation
facility: GSK Investigational Site
city: Ufa
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: