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DiabetesPhase 3NCT01829464

TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes

A Phase 3 study testing TAK-875 in people with Diabetes, run by Takeda at 86 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effect of TAK-875 (fasiglifam) in combination with sitagliptin on glycemic control in adults with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes
What is being tested?
TAK-875
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
86 sitesin 3 countries
Study dates
May 2013to Mar 2014
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 aged 18 years or older with a historical diagnosis of T2DM.
  • The participant meets one of the following criteria:
  • The participant has an HbA1c between 7.5% and 10.5%, inclusive and has been taking a stable dose of sitagliptin 100 mg for at least 8 weeks, with or without metformin, prior to the Screening Visit. A participant who is taking metformin must have received a stable daily dose (≥1500 mg or documented maximum tolerated dose [MTD]) for at least 8 weeks before Screening. This participant will enter the 2-week single-blind Placebo Run-In Period according to Study Schedule A, or;
  • The participant has an HbA1c between 7.5% and 10.5%, inclusive and has been taking any other DPP-IV inhibitor (with or without metformin) for at least 8 weeks prior to the Screening Visit. A participant who is taking metformin must have received a stable daily dose (≥1500 mg or documented MTD) for at least 8 weeks before Screening. This participant will enter the 8-week Switching Period according to Study Schedule B. Following this 8-week period, the participant must qualify for all Inclusion/Exclusion Criteria prior to entering the 2-Week Placebo Run-in Period by completing the Week ( 3) procedures including having an HbA1c level between 7.5% and 10.5%.
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  • Note: An enrollment cap may be applied to ensure no more than approximately 20% of randomized participants are receiving a DPP-IV inhibitor without metformin at baseline.
  • The participant has had no treatment with antidiabetic agents other than DPP-IV inhibitors and metformin within 2 months prior to Screening (Exception: if a participant has received other antidiabetic therapy for ≤7 consecutive days within the 2 months prior to Screening).
  • The participant has a body mass index (BMI) ≤45 kg/m2 at Screening.
  • Participants regularly using other, non-excluded medications must be on a stable dose for at least 4 weeks prior to screening. However, PRN (as needed) use of prescription or over-the-counter medication is allowed at the discretion of the investigator.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use 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.
  • 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.

Who cannot join

  • Has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within 3 months prior to Screening.
  • Has been randomized into a previous TAK-875 study.
  • 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 (eg, spouse, parent, child, or sibling; biological or legally adopted) or may consent under duress.
  • Donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
  • Has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at the Screening Visit.
  • Has a systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening (If the participant meets this exclusion criteria, the assessment may be repeated once at least 30 minutes after the initial measurement and a decision will be made based on the second measurement).
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  • Has history of cancer that has been in remission for <5 years prior to Screening. (Exception: A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.)
  • Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x the upper limit of normal (ULN) at Screening.
  • Has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome, they will be allowed with an elevated bilirubin level per the investigator's discretion.
  • 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.
  • Has uncontrolled thyroid disease.
  • Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
  • Has had gastric banding or gastric bypass surgery within one year prior to Screening.
  • Has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
  • 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 to or at Screening.
  • Has a history of pancreatitis.
  • Has a history of hypersensitivity, allergies or has had an anaphylactic reaction(s) to any component of TAK-875 as well as sitagliptin.
  • Has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
  • Received excluded medications prior to the Screening Visit or is expected to receive excluded medications.
  • If female, is pregnant (confirmed by laboratory testing, ie, serum/urine 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.
  • Is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
  • 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.

Trial locations and contacts

86 sites in 3 countries.

86 sites in 3 countries

United States82 sites

  • Study site

    Albany, New York

  • Study site

    Anaheim, California

  • Study site

    Atlanta, Georgia

  • Study site

    Avon, Indiana

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida

  • Study site

    Boise, Idaho

  • Study site

    Boynton Beach, Florida

  • Study site

    Bradenton, Florida

  • Study site

    Burke, Virginia

  • Study site

    Calabash, North Carolina

  • Study site

    Carrollton, Texas

  • Study site

    Charlotte, North Carolina

  • Apex Medical Research, MI, Inc

    Chicago, Illinois, 60616

  • Study site

    Chicago, Illinois

  • Study site

    Clearwater, Florida

  • Study site

    Cocoa, Florida

  • Study site

    Council Bluffs, Iowa

  • Study site

    Crossville, Tennessee

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    Doral, Florida

  • Study site

    Dothan, Alabama

  • Study site

    El Cajon, California

  • Study site

    Elizabeth, New Jersey

  • Study site

    Fall River, Massachusetts

  • Study site

    Feasterville, Pennsylvania

  • Study site

    Fort Mill, South Carolina

  • Study site

    Fort Worth, Texas

  • Study site

    Greenfield, Indiana

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Harleysville, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Irving, Texas

  • Study site

    Katy, Texas

  • Study site

    Knoxville, Tennessee

  • Study site

    Levittown, Pennsylvania

  • Study site

    Lewisville, Texas

  • Study site

    Long Beach, California

  • Study site

    Manassas, Virginia

  • Study site

    Maumee, Ohio

  • Study site

    McKinney, Texas

  • Study site

    Meridian, Idaho

  • Study site

    Miami, Florida

  • Study site

    Modesto, California

  • Study site

    Morganton, North Carolina

  • Study site

    Muncie, Indiana

  • Study site

    Muscle Shoals, Alabama

  • Study site

    Nashua, New Hampshire

  • Study site

    New Braunfels, Texas

  • Study site

    Norman, Oklahoma

  • Study site

    North Hollywood, California

  • Study site

    North Miami, Florida

  • Study site

    Norwalk, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Owensboro, Kentucky

  • Study site

    Oxon Hill, Maryland

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Pismo Beach, California

  • Study site

    Plano, Texas

  • Study site

    Port Orange, Florida

  • Study site

    Rosedale, New York

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Savannah, Georgia

  • Study site

    Spartanburg, South Carolina

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Tomball, Texas

  • Study site

    Topeka, Kansas

  • Study site

    Uniontown, Pennsylvania

  • Study site

    Vista, California

  • Study site

    Washington, Missouri

  • Study site

    West Hills, California

  • Study site

    West Palm Beach, Florida

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Woodstock, Georgia

Other trials in United States

Argentina3 sites

  • Study site

    Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires

  • Study site

    Rosario, Santa Fe Province

  • Study site

    Salta, Salta Province

Other trials in Argentina

Peru1 site

  • Study site

    Lima

Other trials in Peru

About this study

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

The purpose of this study is to evaluate the effect of TAK-875 (fasiglifam) in combination with sitagliptin on glycemic control in adults with type 2 diabetes.

Read the detailed description

The drug being tested in this study is called TAK-875 (fasiglifam). Fasiglifam is being tested to treat people who have type 2 diabetes mellitus and are currently taking sitagliptin (with or without metformin). This study will evaluate glycemic control in people who take fasiglifam plus sitagliptin compared with placebo plus sitagliptin.

The study will enroll approximately 390 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need; all participants will be on 100 mg sitagliptin and may or may not be on metformin background treatment):

  • fasiglifam 25 mg
  • fasiglifam 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.

This multi-centre trial will be conducted in North America and Latin America. The overall time to participate in this study is approximately 38 weeks. Participants will make 15 visits to the clinic.

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.

Conditions
Diabetes
Being tested
Placebo, TAK-875
Keywords
Drug Therapy
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • PlaceboDrug

    TAK-875 placebo-matching tablets

  • TAK-875Drug

    TAK-875 tablets

  • TAK-875Drug

    TAK-875 tablets

Study groups in NCT01829464
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTAK-875 placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up 24 weeks.
Receives: Drug: Placebo
TAK-875 25 mgExperimentalTAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up to 24 weeks
Receives: Drug: TAK-875
TAK-875 50 mgExperimentalTAK-875 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up to 24 weeks
Receives: Drug: TAK-875

What is being measured

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

  1. Change From Baseline in HbA1c at Week 24

    The change in the value of HbA1c (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.

    Measured: Baseline and Week 24

Secondary outcomes (2)

  1. Percentage of Participants With HbA1c <7%

    Measured: Week 24

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    The change between the fasting plasma glucose values collected at Week 24 relative to baseline.

    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 posted11 Apr 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionFeb 2014
  4. Study completionMar 2014

Why it stopped: Due to potential concerns about liver safety (See Detailed Description)

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01829464
Sponsor's protocol ID
TAK-875_303
Other IDs
U1111-1124-2270
Status last verified
Apr 2016
First submitted
9 Apr 2013
Last updated
1 Jun 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 TAK-875 in people with Diabetes, run by Takeda at 86 sites in 3 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 12 inclusion and 22 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: stopped early, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Argentina, Peru. 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 1 Jun 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 HbA1c at Week 24 (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 NCT01829464, 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 1 Jun 2016.

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