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Diabetes Mellitus, Type 2Phase 3NCT01456195

Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes

A Phase 3 study testing Fasiglifam in people with Diabetes Mellitus, Type 2, run by Takeda at 95 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Fasiglifam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
421 participants
Where
95 sitesin 8 countries
Study dates
Nov 2011to Jul 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant or, when applicable, the participant'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.
  • The participant is male or female and 18 years of age or older with a historical diagnosis of T2DM.
  • The participant has been treated with only diet and exercise for at least 12 weeks prior to Screening and has an HbA1c concentration between 7.0 % and 10.5%, inclusive, at Screening.
  • The participant has received ≤7 days of any antidiabetic agent within 12 weeks prior to Screening.
  • The participant has a body mass index (BMI) ≤45 kg/m^2 at Screening.
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  • Participants regularly using other, non-excluded medications must be on a stable dose for at least 4 weeks prior to Screening. However, as needed (PRN) use of prescription or over-the-counter medication is allowed at the discretion of the investigator.
  • The participant is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete participant diaries.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose of study drug.
  • Additional Inclusion Criteria prior to Randomization
  • The participant has an HbA1c concentration between 7.0 and 10.5%, inclusive, and a fasting plasma glucose (FPG) ≤270 mg/dL (≤15.0 mmol/L) at Week -1 Visit. (If the participant does not qualify for randomization based on these criteria, the assessments may be repeated weekly, for a maximum of 2 additional weeks).
  • The participant's overall compliance with single-blind study medication during the Placebo Run-in Period is at least 75% and does not exceed 125% based on tablet counts performed by the study staff.
  • A female participant of childbearing potential must have a negative urine hCG pregnancy test at Baseline (Visit 4) prior to Randomization and prior to administration of the first dose of double-blind study medication

Who cannot join

  • The participant has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within 3 months prior to Screening.
  • The participant has been randomized in a previous TAK-875 study.
  • The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, or sibling; biological or legally adopted) or may consent under duress.
  • The participant donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
  • The participant has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening.
  • The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Screening (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).
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  • The participant 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.
  • The participant has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x the upper limit of normal (ULN) at Screening.
  • The participant has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome, the participant will be allowed with an elevated bilirubin level per the investigator's discretion.
  • The participant has a serum creatinine ≥1.5 mg/dL(≥133 µmol/L) [males] and ≥1.4 mg/dL (≥124 µmol/L) [females] and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m^2 at Screening.
  • The participant has uncontrolled thyroid disease.
  • The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
  • The participant has had gastric banding or gastric bypass surgery within one year prior to Screening.
  • The participant has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
  • The participant had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram (ECG), cerebrovascular accident or transient ischemic attack within 3 months prior or at Screening.
  • The participant has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875.
  • The participant has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
  • The participant received excluded medications prior to Screening or is expected to receive excluded medication.
  • If female, the participant is pregnant (confirmed by laboratory testing, i.e., serum human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
  • The participant is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
  • The participant has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the participant according to the protocol.
  • Additional Exclusion Criteria prior to Randomization
  • The participant received excluded medications during the Placebo Run-in Period. (Topical and inhaled corticosteroids are allowed).
  • The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Baseline (Visit 4) (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).

Trial locations and contacts

95 sites in 8 countries.

95 sites in 8 countries

United States55 sites

  • Study site

    Avon, Indiana

  • Study site

    Boynton Beach, Florida

  • Study site

    Bradenton, Florida

  • Study site

    Burke, Virginia

  • Study site

    Carrollton, Texas

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Coral Gables, Florida

  • Study site

    Council Bluffs, Iowa

  • Study site

    Crossville, Tennessee

  • Study site

    Dallas, Texas

  • Study site

    Decatur, Georgia

  • Study site

    Dothan, Alabama

  • Study site

    El Pasco, Texas

  • Study site

    Elizabeth, New Jersey

  • Study site

    Flint, Michigan

  • Study site

    Fort Worth, Texas

  • Study site

    Goodyear, Arizona

  • Study site

    Greenfield, Indiana

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Harleysville, Pennsylvania

  • Study site

    Hialeah, Florida

  • Study site

    Houston, Texas

  • Study site

    Irving, Texas

  • Study site

    Largo, Florida

  • Study site

    Levittown, Pennsylvania

  • Study site

    Lexington, Kentucky

  • Study site

    Long Beach, California

  • Study site

    Manassas, Virginia

  • Study site

    Maumee, Ohio

  • Study site

    Mooresville, North Carolina

  • Study site

    Morganton, North Carolina

  • Study site

    Muncie, Indiana

  • Study site

    Muscle Shoals, Alabama

  • Study site

    New Braunfels, Texas

  • Study site

    New Port Richey, Florida

  • Study site

    North Hollywood, California

  • Study site

    Norwalk, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Oxon Hill, Maryland

  • Study site

    Palm Springs, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Picayune, Mississippi

  • Study site

    Pismo Beach, California

  • Study site

    Raleigh, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Spring, Texas

  • Study site

    Tomball, Texas

  • Study site

    Topeka, Kansas

  • Study site

    Uniontown, Pennsylvania

Other trials in United States

Slovakia10 sites

  • Study site

    Banská Bystrica

  • Study site

    Bratislava

  • Study site

    Dolný Kubín

  • Study site

    Komárno

  • Study site

    Levice

  • Study site

    Pezinok

  • Study site

    Prievidza

  • Study site

    Trebišov

  • Study site

    Trenčín

  • Study site

    Žilina

Other trials in Slovakia

Ukraine8 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Odesa

  • Study site

    Simferopol

  • Study site

    Ternopil

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Argentina6 sites

  • Study site

    Buenos Aires, Ciudad Autonoma Buenos Aires

  • Study site

    Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires

  • Study site

    Córdoba, Córdoba Province

  • Study site

    Corrientes, Corrientes Province

  • Study site

    Mendoza, Mendoza Province

  • Study site

    Villa Cabrera, Córdoba Province

Other trials in Argentina

Hungary6 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Kecskemét

  • Study site

    Komárom

  • Study site

    Szikszó

  • Study site

    Zalaegerszeg

Other trials in Hungary

Bulgaria5 sites

  • Study site

    Byala

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Guatemala3 sites

  • Study site

    Guatemala City

  • Study site

    Quetzaltenango

  • Study site

    Zacapa

Other trials in Guatemala

Mexico2 sites

  • Study site

    Mexico City, Mexico City

  • Study site

    Monterrey, Nuevo León

Other trials in Mexico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared With Placebo in Subjects With Type 2 Diabetes

The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).

Read the detailed description

TAK-875 is being developed at Takeda Development Center, Inc. as an adjunct to diet and exercise to improve glycemic control in patients with T2DM.

This study will investigate TAK-875 in participants with type 2 diabetes mellitus who have been treated with only diet and exercise for at least 12 weeks prior to Screening, who have taken ≤7 days of any antidiabetic agent within the 12 weeks prior to Screening, and whose glycemic control is inadequate.

Being tested
Placebo, Fasiglifam
Keywords
Drug Therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Fasiglifam placebo-matching tablets

  • FasiglifamDrug

    Fasiglifam tablets

Study groups in NCT01456195
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
Receives: Drug: Placebo
Fasiglifam 25 mgExperimentalFasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
Receives: Drug: Fasiglifam
Fasiglifam 50 mgExperimentalFasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
Receives: Drug: Fasiglifam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.

    Measured: Baseline and Week 24

Secondary outcomes (3)

  1. Incidence of HbA1c <7%

    The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24.

    Measured: Week 24

  2. Change From Baseline in Fasting Plasma Glucose

    The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL). A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.

    Measured: Baseline and Week 24

  3. Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)

    The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L). An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis.

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01456195
Sponsor's protocol ID
TAK-875_301
Other IDs
2011-002741-35, U1111-1124-2154
Status last verified
Mar 2016
First submitted
18 Oct 2011
Last updated
5 Apr 2016
Data monitoring committee
Yes

Publications

  • Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.

    PubMed 30880443

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fasiglifam in people with Diabetes Mellitus, Type 2, run by Takeda at 95 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Slovakia, Ukraine, Argentina, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01456195, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.

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