Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease

This study has been terminated.
(Due to potential concerns about liver safety (See Detailed Description))
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01609582
First received: May 29, 2012
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo.


Condition Intervention Phase
Type 2 Diabetes
Cardiovascular Disease
Drug: TAK-875
Drug: TAK-875 Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects With Type 2 Diabetes and With Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Time to the first occurrence of any component of the primary major adverse cardiovascular event (MACE) composite [ Time Frame: 6 years. ] [ Designated as safety issue: Yes ]

    The time to the first occurrence of any component of the primary MACE composite, including:

    • Cardiovascular death
    • Nonfatal Myocardial infarction
    • Nonfatal stroke
    • Hospitalization for unstable angina (with or without revascularization)


Secondary Outcome Measures:
  • The time to first occurrence of any component of the secondary major adverse cardiovascular event MACE composite [ Time Frame: 6 years. ] [ Designated as safety issue: Yes ]

    The time to first occurrence of any component of the secondary MACE composite, including:

    • CV death
    • Nonfatal myocardial infarction
    • Nonfatal stroke


Enrollment: 3207
Study Start Date: June 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-875 50 mg
TAK-875 50 mg tablets, orally, once daily for up to 6 years.
Drug: TAK-875
TAK-875 tablets
Placebo Comparator: Placebo
TAK-875 placebo-matching tablets, orally, once daily for up to 6 years.
Drug: TAK-875 Placebo
TAK-875 placebo-matching tablets

Detailed Description:

The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have diabetes. This study will look at the number of cardiovascular events (for example, heart attacks) of people who take TAK-875 in addition to standard care.

The study will enroll approximately 5000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • TAK-875 50 mg.
  • Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to record any time they have low blood sugar symptoms in a diary.

This multi-centre trial will be conducted worldwide, in approximately 700 sites. The overall time to participate in this study is 6 years. Participants will make up to approximately 24 visits to the clinic, with telephone visits conducted on an alternate 6 month schedule starting from Month 27.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

  Eligibility

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

Inclusion Criteria:

  1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements, including scheduled clinic appointments.
  2. The patient or, when applicable, the patient's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  3. Has a diagnosis of type 2 diabetes mellitus.
  4. Has an glycosylated hemoglobin (HbA1c) level between 7.0% and 10.5%, inclusive, at Screening. HbA1c testing may be repeated once during Screening.
  5. Meets at least one (1) of the following three (3) High Risk Categories (a-c ):

    1. A documented history of myocardial infarction (MI) occurring no less than 2 months (60 days) and no greater than 24 months prior to Screening.
    2. Documented symptomatic peripheral arterial disease (PAD) (at least one (1) of the following three (3) criteria must be satisfied):

    i) Current intermittent claudication together with documented ankle-brachial index ≤0.85.

    ii) History of previous vascular intervention for intermittent claudication or resting limb ischemia (example: amputation for arterial disease, peripheral bypass, or history of angioplasty/stenting).

    iii) History of symptomatic carotid artery disease (requiring revascularization with carotid endarterectomy (CEA) or stenting).

    c) Documented cerebrovascular disease (at least one (1) of the following two (2) criteria must be satisfied): i) A history of transient ischemic attack (TIA) confirmed by a neurologist no greater than 24 months prior to screening and clinically and neurologically stable at randomization.

    ii) A history of ischemic stroke (IS) (with a Modified Rankin Scale Score ≤3 documented prior to Randomization) not less than 2 months (60 days) and no greater than 24 months prior to Screening, and clinically and neurologically stable at Randomization. The Modified Rankin Scale is located in appendix in protocol.

    Or meets at least one (1) of the following five (5) Intermediate Risk Categories (d-h):

    d)Stable angina with coronary disease documented by the presence of inducible ischemia or scar by stress myocardial perfusion imaging (MPI), echocardiogram or magnetic resonance imaging (MRI) in the past 24 months.

    e) Multi vessel coronary disease, based on coronary angiography, with or without angina, documented by >50% diameter stenosis in at least 2 of the 3 major coronary distributions.

    f)A history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 2 months prior to Screening.

    g) The subject has diabetic nephropathy plus (2) of the clinical criteria listed below (i. to vi.). Diabetic nephropathy is defined as either urinary albumin excretion ≥ 30 µg/mg creatinine (3.4 mg/mmol creatinine) (based on a random spot collection) or urinary albumin excretion ≥ 30 mg/24h (based on a 24 h or timed collection). Results must be confirmed on at least two specimens collected within 12 months prior to Screening and no more than 6 months apart.: i. Duration of diabetes ≥ 10 years on pharmacological treatment documented within medical records ii) Confirmed systolic blood pressure (SBP) ≥150 mm Hg on 2 separate days during Screening despite treatment with at least 2 anti-hypertensive medications administered at doses considered optimal by local standard of care.

    iii) Presence of dyslipidemia as defined by any one (1) of the following confirmed at screening:

1. Low density lipoprotein (LDL) > 100 mg/dl (2.59 mmol/L) while on statin therapy administered at maximum tolerated dose or optimal dose based on local standard of care for at least 4 weeks prior to screening..

2. LDL > 130 mg/dL (3.37 mmol/L) when not on statin therapy. 3. High density lipoprotein (HDL) < 40 mg/dL (1.04 mmol/L) in males or < 45 mg/dL (1.17 mmol/L) in females.

4. Fasting Triglyceride >200 mg/dL(2.26 mmol/L). iv) Currently smoking >10 cigarettes per day at Screening. v) Male ≥65 years of age or female ≥70 years of age. vi) Highly selective C-reactive protein (hs-CRP) > 2.0 mg/L in the absence of intercurrent infection or acute process.

h.) The subject meets at least five (5) of the following clinical criteria: i.) Duration of diabetes ≥10 years on pharmacological treatment documented within medical records.

ii) Confirmed systolic blood pressure (SBP) ≥150 mm Hg on 2 separate days during Screening despite treatment with at least 2 anti-hypertensive medications administered at doses considered optimal by local standard of care.

iii) Presence of dyslipidemia as defined by any one (1) of the following confirmed at screening:

  1. Low density lipoprotein (LDL) > 100 mg/dl (2.59 mmol/L) while on statin therapy administered at maximum tolerated dose or optimal dose based on local standard of care for at least 4 weeks prior to screening..
  2. LDL > 130 mg/dL (3.37 mmol/L) when not on statin therapy.
  3. High density lipoprotein (HDL) < 40 mg/dL (1.04 mmol/L) in males or < 45 mg/dL (1.17 mmol/L) in females.
  4. Fasting Triglyceride >200 mg/dL(2.26 mmol/L). iv) Currently smoking >10 cigarettes per day at Screening. v) Male ≥65 years of age or female ≥70 years of age. vi) Highly selective C-reactive protein (hs-CRP) > 2.0 mg/L in the absence of intercurrent infection or acute process.

6. Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations in patient diaries.

7. A female of childbearing potential who is sexually active with a non-sterilized male partner agrees to routinely use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug.

8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN) and if ALT or AST elevated above ULN, have chronic, well-compensated liver disease documented by usual clinical parameters.

Exclusion Criteria:

  1. Has received any investigational medication within 30 days prior to Screening or any investigational antidiabetic medication or excluded medications within 3 months prior to Screening.
  2. Has been randomized into a previous TAK-875 study.
  3. Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, biological or legally adopted child, or sibling) or may consent under duress
  4. Is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
  5. Is hemodynamically unstable, including severe heart failure (New York Heart Association Class IV) at Screening.
  6. Is hospitalized at the Screening Visit for the event associated with the CV inclusion criteria. (Patients who have been discharged from an acute hospital to a cardiac rehabilitation center or nursing home at the time of the Screening Visit or Randomization Visit are not excluded).
  7. Has ALT and/or AST levels >3.0x ULN at Screening.
  8. Has a total bilirubin level >ULN at Screening. Exception: if a patient has documented Gilbert's Syndrome, the patient will be allowed with an elevated bilirubin level per the investigator's discretion.
  9. Has an glomerular filtration rate (estimated) (eGFR) ≤ 15 mL/min/1.73m2 based on Modification of Diet in Renal Disease (MDRD) calculation at Screening and is currently on dialysis or expected to start dialysis within the next 6 months.
  10. Has uncontrolled thyroid disease, as determined by the investigator and/or clinical investigation.
  11. Has a known history of infection with human immunodeficiency virus (HIV).
  12. Has a known active infection with Hepatitis B virus (HBV), or Hepatitis C virus (HCV) requiring antiviral treatment.
  13. Has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
  14. Has any major illness or condition that, in the investigator's opinion, prohibits the patient from participating in the study or meeting the planned visit schedule.
  15. Has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to TAK-875.
  16. If female, is pregnant (confirmed by laboratory testing, ie, serum or urine human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
  17. Is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
  18. Has a history of cancer that has been in remission for <5 years prior to Screening. A history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed.
  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: NCT01609582

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
Dothan, Alabama, United States
Mobile, Alabama, United States
Muscle Shoals, Alabama, United States
Pell City, Alabama, United States
United States, Arizona
Goodyear, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Anaheim, California, United States
El Cajon, California, United States
Fresno, California, United States
Fullerton, California, United States
La Mesa, California, United States
Laguna Hills, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
National City, California, United States
Newport Beach, California, United States
Orange, California, United States
Paramount, California, United States
Pismo Beach, California, United States
Redondo Beach, California, United States
San Diego, California, United States
San Francisco, California, United States
San Franciso, California, United States
Stockton, California, United States
Thousand Oaks, California, United States
Torrance, California, United States
Valley Village, California, United States
Westlake Village, California, United States
United States, Colorado
Denver, Colorado, United States
Lakewood, Colorado, United States
United States, Connecticut
Bridgeport, Connecticut, United States
Danbury, Connecticut, United States
United States, Delaware
Seaford, Delaware, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Boynton Beach, Florida, United States
Brandon, Florida, United States
Chipley, Florida, United States
Clearwater, Florida, United States
Cocoa, Florida, United States
Coral Gables, Florida, United States
Coral Springs, Florida, United States
Crystal River, Florida, United States
Delray Beach, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Jacksonville Beach, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Ocala, Florida, United States
Oviedo, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Trinity, Florida, United States
Vero Bearch, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
Calhoun, Georgia, United States
Conyers, Georgia, United States
Cumming, Georgia, United States
Norcross, Georgia, United States
Roswell, Georgia, United States
Suwanee, Georgia, United States
Woodstock, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
LaGrange, Illinois, United States
Springfield, Illinois, United States
United States, Indiana
Anderson, Indiana, United States
Avon, Indiana, United States
Elkhart, Indiana, United States
Greenfield, Indiana, United States
Indianapolis, Indiana, United States
Muncie, Indiana, United States
United States, Iowa
Ames, Iowa, United States
Council Bluffs, Iowa, United States
Waterloo, Iowa, United States
United States, Kansas
Augusta, Kansas, United States
Hutchinson, Kansas, United States
Newton, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
United States, Kentucky
Elizabethtown, Kentucky, United States
United States, Louisiana
Marrero, Louisiana, United States
Monroe, Louisiana, United States
Natchitoches, Louisiana, United States
New Orleans, Louisiana, United States
Sherveport, Louisiana, United States
United States, Maine
Portland, Maine, United States
United States, Maryland
Annapolis, Maryland, United States
Balitmore, Maryland, United States
Baltimore, Maryland, United States
United States, Massachusetts
Fall River, Massachusetts, United States
Hyannis, Massachusetts, United States
Natick, Massachusetts, United States
Springfield, Massachusetts, United States
United States, Michigan
Bay City, Michigan, United States
Cadillac, Michigan, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Mt. Clemens, Michigan, United States
Novi, Michigan, United States
Pontiac, Michigan, United States
Saginaw, Michigan, United States
Troy, Michigan, United States
United States, Minnesota
Baxter, Minnesota, United States
St. Cloud, Minnesota, United States
St. Paul, Minnesota, United States
United States, Missouri
Columbia, Missouri, United States
Kansas City, Missouri, United States
St. Louis, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Hampshire
Nashua, New Hampshire, United States
United States, New Jersey
Bridgewater, New Jersey, United States
Elizabeth, New Jersey, United States
Haddon Heights, New Jersey, United States
Linden, New Jersey, United States
Mine Hill, New Jersey, United States
Somerset, New Jersey, United States
South Plainfield, New Jersey, United States
Toms Rivers, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Brooklyn, New York, United States
Buffalo, New York, United States
Mineola, New York, United States
New York, New York, United States
Saratoga Springs, New York, United States
Smithtown, New York, United States
Syracuse, New York, United States
United States, North Carolina
Burlington, North Carolina, United States
Calabash, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Lenoir, North Carolina, United States
Mooresville, North Carolina, United States
Morganton, North Carolina, United States
Raleigh, North Carolina, United States
Rocky Mount, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Fairview Park, Ohio, United States
Gallipolis, Ohio, United States
Kettering, Ohio, United States
Marion, Ohio, United States
Middleburg Heights, Ohio, United States
Perrysburg, Ohio, United States
Springfield, Ohio, United States
Toledo, Ohio, United States
Willoughby Hills, Ohio, United States
United States, Oklahoma
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Chambersburg, Pennsylvania, United States
Hanleysville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Levittown, Pennsylvania, United States
Norristown, Pennsylvania, United States
Philadelphi, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Scotland, Pennsylvania, United States
Uniontown, Pennsylvania, United States
United States, Rhode Island
East Providence, Rhode Island, United States
Pawtucket, Rhode Island, United States
United States, South Carolina
Columbia, South Carolina, United States
Greer, South Carolina, United States
Laurens, South Carolina, United States
Simpsonville, South Carolina, United States
United States, Tennessee
Bristol, Tennessee, United States
Crossville, Tennessee, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Oak Ridge, Tennessee, United States
Tullahoma, Tennessee, United States
United States, Texas
Austin, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Katy, Texas, United States
Midland, Texas, United States
Odessa, Texas, United States
Pearland, Texas, United States
San Antonio, Texas, United States
Spring, Texas, United States
Tomball, Texas, United States
Victoria, Texas, United States
United States, Utah
Bountiful, Utah, United States
Layton, Utah, United States
Salt Lake City, Utah, United States
United States, Virginia
Alexandria, Virginia, United States
Danville, Virginia, United States
Falls Church, Virginia, United States
Hampton, Virginia, United States
Manassas, Virginia, United States
United States, Washington
Wenatchee, Washington, United States
United States, West Virginia
Huntington, West Virginia, United States
Lewisburg, West Virginia, United States
United States, Wisconsin
La Crosse, Wisconsin, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Argentina
Bahia Blanca, Buenos Aires, Argentina
Haedo, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Loma Hermosa, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Quilmes, Buenos Aires, Argentina
San Nicolas, Buenos Aires, Argentina
Zarate, Buenos Aires, Argentina
Trelew, Chubut, Argentina
Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Córdoba, Cordoba, Argentina
Villa Cabrera, Cordoba, Argentina
Villa Maria, Cordoba, Argentina
San Salvador de Jujuy, Jujy, Argentina
Godoy Cruz, Mendoza, Argentina
Cipolletti, Rio Negro, Argentina
Rosario, Santa Fe, Argentina
Venado Tuerto, Santa Fe, Argentina
San Miguel de Tucuman, Tucuman, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Cordoba, Argentina
Corrientes, Argentina
Mendoza, Argentina
Rosario, Argentina
Salta, Argentina
Santa Fe, Argentina
Santiago del estero, Argentina
Australia, Australian Capital Territory
Bruce, Australian Capital Territory, Australia
Canberra, Australian Capital Territory, Australia
Garran, Australian Capital Territory, Australia
Australia, New South Wales
Westmead, New South Wales, Australia
Wollongong, New South Wales, Australia
Australia, Queensland
Brisbane, Queensland, Australia
Meadowbrook, Queensland, Australia
Milton, Queensland, Australia
Townsville, Queensland, Australia
Woolloongabba, Queensland, Australia
Australia, South Australia
Adelaide, South Australia, Australia
Daw Park, South Australia, Australia
Elizabeth Vale, South Australia, Australia
Australia, Victoria
Clayton, Victoria, Australia
Fitzroy, Victoria, Australia
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Sale, Victoria, Australia
Australia, Western Australia
Joondalup, Western Australia, Australia
Australia
Bruce, Australia
Garran, Australia
Brazil
Fortaleza, Ceará, Brazil
Brasilia, Distrito Federal, Brazil
Goiania, Goiás, Brazil
Campina Grande do Sul, Paraná, Brazil
Curitiba, Paraná, Brazil
Belem, Pará, Brazil
Recife, Pernambuco, Brazil
Canoas, Rio Grande do Sul, Brazil
Caxias do Sul, Rio Grande do Sul, Brazil
Passo Fundo, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Santa Maria, Rio Grande do Sul, Brazil
Marilia, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Sao Paulo, Brazil
Bulgaria
Blagoevgrad, Bulgaria
Byala, Bulgaria
Kazanlak, Bulgaria
Pazardzhik, Bulgaria
Plovdiv, Bulgaria
Sevlievo, Bulgaria
Sofia, Bulgaria
Stara Zagora, Bulgaria
Varna, Bulgaria
Canada, Alberta
Calgary, Alberta, Canada
Spruce Grove, Alberta, Canada
Canada, British Columbia
Victoria, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Brampton, Ontario, Canada
Etobicoke, Ontario, Canada
Hamilton, Ontario, Canada
Markham, Ontario, Canada
Oakville, Ontario, Canada
Ottawa, Ontario, Canada
Sudbury, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Gatineau, Quebec, Canada
Laval, Quebec, Canada
Longueuil, Quebec, Canada
Montreal, Quebec, Canada
Pointe Claire, Quebec, Canada
St-Jérôme, Quebec, Canada
Ville Saint-Laurent, Quebec, Canada
Canada
Quebec, Canada
Croatia
Cakovec, Croatia
Karlovac, Croatia
Koprivnica, Croatia
Krapinske Toplice, Croatia
Osijek, Croatia
Rijeka, Croatia
Sisak, Croatia
Slavonski Brod, Croatia
Split, Croatia
Virovitica, Croatia
Zadar, Croatia
Zagreb, Croatia
Czech Republic
Ceske Budejovice, Czech Republic
Chocen, Czech Republic
Jindrichuv Hradec, Czech Republic
Kromeriz, Czech Republic
Marianske Lazne, Czech Republic
Moravsky Krumlov, Czech Republic
Olomouc, Czech Republic
Ostrava, Czech Republic
Ostrava - Moravska Ostrava, Czech Republic
Ostrava - Vitkovice, Czech Republic
Prague 10, Czech Republic
Praha 4 - Krc, Czech Republic
Praha 5, Czech Republic
Slany, Czech Republic
Trutnov, Czech Republic
Usti nad Labem, Czech Republic
Estonia
Paide, Estonia
Tallinn, Estonia
Tartu, Estonia
France
Corbeil Essonne, Essonne, France
Corbeil Essonnes, Essonne, France
Pessac, Gironde, France
Nanterre cedex, Hauts de Seine, France
Nantes cedex 01, Loire Atlantique, France
Pierre-Bénite cedex, Rhone, France
Paris, France
Germany
Friedrichsthal, Baden Wuerttemberg, Germany
Falkensee, Brandenburg, Germany
Kelkheim, Hessen, Germany
Dortmund, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Goch, Nordrhein Westfalen, Germany
Kamp-Lintfort, Nordrhein Westfalen, Germany
Koeln, Nordrhein Westfalen, Germany
Bad Kreuznach, Rheinland Pfalz, Germany
Hohenmoelsen, Sachsen Anhalt, Germany
Dippoldiswalde, Sachsen, Germany
Dresden, Sachsen, Germany
Berlin, Germany
Hamburg, Germany
Hong Kong
Hong Kong, Hong Kong
New Territories, Hong Kong
Hungary
Baja, Hungary
Balatonfured, Hungary
Budaors, Hungary
Budapest, Hungary
Debrecen, Hungary
Eger, Hungary
Godollo, Hungary
Gyula, Hungary
Kecskemet, Hungary
Kistelek, Hungary
Komarom, Hungary
Mako, Hungary
Pecs, Hungary
Szeged, Hungary
Szekszard, Hungary
Szikszo, Hungary
Szombathely, Hungary
Urhida, Hungary
Veszprem, Hungary
Zalaegerszeg, Hungary
Israel
Ashkelon, Israel
Beer Sheva, Israel
Beer Yaakov, Israel
Beer-Sheva, Israel
Givataim, Israel
Hadera, Israel
Haifa, Israel
Holon, Israel
Jerusalem, Israel
Kfar-Saba, Israel
Petach Tikva, Israel
Petach Tikwa, Israel
Raanana, Israel
Tel Aviv, Israel
Zefat, Israel
Italy
San Donato Milanese, Milano, Italy
Sesto San Giovanni, Milano, Italy
Firenze, Italy
Milano, Italy
Pavia, Italy
Korea, Republic of
Wonju-Si, Gangwon-do, Korea, Republic of
Seongnam-si, Gyeonggi-do, Korea, Republic of
Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Jeonju-si, Jeollabuk-do, Korea, Republic of
Busan, Korea, Republic of
Gyeonggi, Korea, Republic of
Seoul, Korea, Republic of
Latvia
Daugavpils, Latvia
Jelgava, Latvia
Limbazi, Latvia
Ogre, Latvia
Riga, Latvia
Talsi, Latvia
Valmiera, Latvia
Lithuania
Alytus, Lithuania
Kaunas, Lithuania
Klaipeda, Lithuania
Malaysia
Johor Bahru, Johor, Malaysia
Alor Setar, Kedah, Malaysia
Kota Bahru, Kelantan, Malaysia
Kota Bharu, Kelantan, Malaysia
Lembah Pantai, Kuala Lumpur, Malaysia
Ipoh, Perak, Malaysia
Taiping, Perak, Malaysia
Taiping, Perak, Perak, Malaysia
Petaling Jaya, Selangor, Malaysia
Kelantan, Malaysia
Kuala Lumpur, Malaysia
Melaka, Malaysia
Selangor, Malaysia
Terengganu, Malaysia
Mexico
Tijuana, Baja California Norte, Mexico
Torreon, Coahuila, Mexico
Cuauhtemoc, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Cuautitlan Izcalli, Estado de Mexico, Mexico
Metepec, Estado de Mexico, Mexico
Acapulco de Juárez, Guerrero, Mexico
Pachuca, Hidalgo, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Morelia, Michoacán, Mexico
Cuernavaca, Morelos, Mexico
Monterrey, Nuevo Le=n, Mexico
Monterrey, Nuevo Leon, Mexico
Monterrey, Nuevo León, Mexico
San Luis Potosi, San Luis Potos, Mexico
Culiacan, Sinaloa, Mexico
Xalapa, Veracruz, Mexico
Merida, Yucatán, Mexico
Aguascalientes, Mexico
Chihuahua, Mexico
Durango, Mexico
Tamaulipas, Mexico
New Zealand
Auckland, New Zealand
Christchurch, New Zealand
Dunedin, New Zealand
Palmerston North, New Zealand
Tauranga, New Zealand
Wellington, New Zealand
Peru
Callao, Peru
Cusco, Peru
Huacho, Peru
Ica, Peru
La Libertad, Peru
Lima, Peru
Piura, Peru
Philippines
Baguio City, Philippines
Cebu City, Philippines
Dasmariñas City, Cavite, Philippines
Davao City, Philippines
Iloilo City, Philippines
Marikina City, Philippines
Quezon City, Philippines
Tarlac, Philippines
Taytay, Philippines
Poland
Bialystok, Poland
Gdansk, Poland
Gliwice, Poland
Grodzisk Mazowiecki, Poland
Kamieniec Zabkowicki, Poland
Leczyca, Poland
Lodz, Poland
Lublin, Poland
Oswiecim, Poland
Parczew, Poland
Poznan, Poland
Pulawy, Poland
Radom, Poland
Ruda Slaska, Poland
Rzeszow, Poland
Warszawa, Poland
Wroclaw, Poland
Romania
Bacau, Romania
Baia Mare, Romania
Brasov, Romania
Bucuresti, Romania
Galati, Romania
Iasi, Romania
Oradea, Romania
Ploiesti, Romania
Targu Mures, Romania
Timisoara, Romania
Russian Federation
Arkhangelsk, Russian Federation
Barnaul, Russian Federation
Kazan, Russian Federation
Kemerovo, Russian Federation
Moscow, Russian Federation
Nizhniy Novgorod, Russian Federation
Novosibirsk, Russian Federation
Pushkin, Russian Federation
Saratov, Russian Federation
St. Petersburg, Russian Federation
Yaroslavl, Russian Federation
Slovakia
Bratislava, Slovakia
Komarno, Slovakia
Kosice, Slovakia
Levice, Slovakia
Lucenec, Slovakia
Martin, Slovakia
Nitra, Slovakia
Nove Mesto nad Vahom, Slovakia
Presov, Slovakia
Sahy, Slovakia
Svidnik, Slovakia
Trencin, Slovakia
Zilina, Slovakia
South Africa
Port Elizabeth, Eastern Cape, South Africa
Bloemfontein, Free State, South Africa
Johannesburg, Gauteng, South Africa
Kempton Park, Gauteng, South Africa
Krugersdorp, Gauteng, South Africa
Lenasia, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Stellenbosch, Western Cape, South Africa
Worcester, Western Cape, South Africa
Taiwan
Douliou City, Taiwan
Kaohsiung, Taiwan
New Taipei City, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Thailand
Bangkoknoi, Bangkok, Thailand
Dusit, Bangkok, Thailand
Patumwan, Bangkok, Thailand
Rachathevi, Bangkok, Thailand
Rajtevi, Bangkok, Thailand
Ratchathewi, Bangkok, Thailand
Muang, Chiang Mai, Thailand
Muang, Chiang Rai, Thailand
Muang, Khon Kaen, Thailand
Muang, Nakhon Ratchasima, Thailand
Ukraine
Donetsk, Ukraine
Kharkiv, Ukraine
Kyiv, Ukraine
Lugansk, Ukraine
Mykolayiv, Ukraine
Odesa, Ukraine
Poltava, Ukraine
Simferopol, Ukraine
Ternopil, Ukraine
Vinnycia, Ukraine
Vinnytsia, Ukraine
Zaporizhzhia, Ukraine
United Kingdom
Truro, Cornwall, United Kingdom
Exeter, Devon, United Kingdom
Plymouth, Devon, United Kingdom
Torquay, Devon, United Kingdom
Hull, East Riding of Yorkshire, United Kingdom
Bexhill on Sea, East Sussex, United Kingdom
Portsmouth, Hampshire, United Kingdom
Watford, Hertfordshire, United Kingdom
Gillingham, Kent, United Kingdom
Thornton-Cleveleys, Lancashire, United Kingdom
Leicester, Leicestershire, United Kingdom
Liverpool, Merseyside, United Kingdom
Harrow, Middlesex, United Kingdom
Northwood, Middlesex, United Kingdom
Stoke on Trent, Staffordshire, United Kingdom
Swansea, West Glamorgan, United Kingdom
Cardiff, United Kingdom
Sponsors and Collaborators
Takeda
Investigators
Study Director: Sr. Medical Director Clinical Science Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01609582     History of Changes
Other Study ID Numbers: TAK-875_306, 2011-001732-37, U1111-1129-7824, TAK-875_306CTIL, DOH-27-0313-4117, 12/SC/0504, NMRR-12-433-12087
Study First Received: May 29, 2012
Last Updated: January 24, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Bulgaria: Ministry of Health
Canada: Health Canada
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Ethics Committee
Hungary: National Institute of Pharmacy
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health
Mexico: Ministry of Health
New Zealand: Medsafe
Peru: Ministry of Health
Philippines: Department of Health
Poland: Ministry of Health
Romania: State Institute for Drug Control
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Taiwan: Department of Health
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: National Health Service
United States: Food and Drug Administration

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014