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Type 2 Diabetes MellitusPhase 2NCT01982253

Fasiglifam 25 mg BID vs 50 mg QD

A Phase 2 study testing Fasiglifam in people with Type 2 Diabetes Mellitus, run by Takeda at 88 sites in 7 countries.

Terminated

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

Official record
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Trial summary

To evaluate the efficacy of fasiglifam 25 mg twice daily (BID) and fasiglifam 50 mg once daily (QD) on glycemic control in adults with type 2 diabetes who are inadequately controlled on diet and exercise alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
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
10 participants
Where
88 sitesin 7 countries
Study dates
Oct 2013to Jan 2014
Phase
Phase 2
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.
  • Is male or female and 18 years of age or older with a historical diagnosis of Type 2 Diabetes Mellitus (T2DM).
  • Has a glycosylated hemoglobin (HbA1c) level ≥7.0% and ≤10.0% and fasting plasma glucose (FPG) ≤270 mg/dL (15.0 mmol/L) at Screening Visit.
  • Has been treated with diet and exercise but has not received treatment with antidiabetic agents within 12 weeks prior to Screening Visit (Exception: if a patient has received other antidiabetic therapy for ≤7 days in total within the 2 months prior to Screening Visit).
  • Has a body mass index (BMI) ≤45 kg/m^2 at Screening.
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  • If regularly using other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening Visit. However, as needed (PRN) use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
  • Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete subject diaries.
  • A female of childbearing potential who is sexually active with a non-sterilized 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.

Who cannot join

  • Has received any investigational compound within 30 days prior to Screening Visit or has received an investigational anti-diabetic drug within the 3 months prior to Screening Visit.
  • Was randomized into a previous fasiglifam 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, sibling) or may consent under duress.
  • Has 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 g/L) for males and ≤10 g/dL (≤100 g/L) for females at Screening.
  • Has a systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening
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  • 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.
  • Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0× upper limit of normal (ULN) at Screening.
  • Has a total bilirubin level greater than the 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.
  • Has a serum creatinine ≥1.5 mg/dL (≥133μmol/L) (males) and ≥1.4 mg/dL (≥124 μmol/L) (females) and/or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2 at Screening.
  • Has uncontrolled thyroid disease as determined by the investigator.
  • Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
  • 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, or hepatitis C virus.
  • 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 hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of fasiglifam.
  • 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 Screening Visit or is expected to receive excluded medication.
  • 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.
  • The subject 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 subject 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 subject according to the protocol.

Trial locations and contacts

88 sites in 7 countries.

88 sites in 7 countries

United States47 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Avon, Indiana

  • Study site

    Boynton Beach, 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

    Corvallis, Oregon

  • Study site

    Council Bluffs, Iowa

  • Study site

    Dallas, Texas

  • Study site

    Decatur, Georgia

  • Study site

    Edinburg, Texas

  • Study site

    Flint, Michigan

  • Study site

    Franklin, Indiana

  • Study site

    Goodyear, Arizona

  • Study site

    Greenfield, Indiana

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Harleysville, Pennsylvania

  • Study site

    Houstan, Texas

  • Study site

    Houston, Texas

  • Study site

    Levittown, Pennsylvania

  • Study site

    Lexington, Kentucky

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Manassas, Virginia

  • Study site

    Maumee, Ohio

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Mooresville, North Carolina

  • Study site

    Morganton, North Carolina

  • Study site

    Muncie, Indiana

  • Study site

    New Braunfels, Texas

  • Study site

    Norman, Oklahoma

  • Study site

    North Hollywood, California

  • Study site

    Norwalk, California

  • Study site

    Orlando, Florida

  • Study site

    Pembroke Pines, Florida

  • Study site

    Portland, Oregon

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Spring, Texas

  • Study site

    Topeka, Kansas

  • Study site

    Tustin, California

  • Study site

    Uniontown, Pennsylvania

Other trials in United States

Slovakia12 sites

  • Study site

    Bardejov

  • Study site

    Bratislava

  • Study site

    Dolný Kubín

  • Study site

    Komárno

  • Study site

    Levice

  • Study site

    Lučenec

  • Study site

    Nitra

  • Study site

    Pezinok

  • Study site

    Sabinov

  • Study site

    Stropkov

  • Study site

    Štúrovo

  • Study site

    Svidník

Other trials in Slovakia

Bulgaria7 sites

  • Study site

    Byala

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Rousse

  • Study site

    Sevlievo

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Poland7 sites

  • Study site

    Lodz

  • Study site

    Oświęcim

  • Study site

    Poznan

  • Study site

    Rzeszów

  • Study site

    Sobótka

  • Study site

    Torun

  • Study site

    Zgierz

Other trials in Poland

Romania6 sites

  • Study site

    Baia Mare

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Iași

  • Study site

    Oradea

  • Study site

    Ploieşti

Other trials in Romania

Ukraine5 sites

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Simferopol

  • Study site

    Ternopil

  • Study site

    Vinnytsia

Other trials in Ukraine

Taiwan4 sites

  • Study site

    Kaohsiung City

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind Parallel-Group, Multicenter Study to Evaluate the Glycemic Effects and Safety of Fasiglifam 25 mg Twice Daily and 50 mg Once Daily on Glycemic Control in Subjects With Type 2 Diabetes

To evaluate the efficacy of fasiglifam 25 mg twice daily (BID) and fasiglifam 50 mg once daily (QD) on glycemic control in adults with type 2 diabetes who are inadequately controlled on diet and exercise alone.

Read the detailed description

The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to treat people who have diabetes. This study will look at glycemic control in people who take fasiglifam.

The study will enroll approximately 400 patients. Participants will be randomly assigned (by chance) 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):

  • Fasiglifam 25 mg twice a day
  • Fasiglifam 50 mg once daily
  • 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 twice each day throughout the study. All participants will be asked to record any time they have symptoms of hypoglycemia in a diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 18 weeks. Participants will make 9 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.

Being tested
Fasiglifam, Placebo to 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.

  • FasiglifamDrug

    Also called TAK-875

    Fasiglifam tablets

  • Placebo to fasiglifamDrug

    Fasiglifam placebo-matching tablets

Study groups in NCT01982253
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFasiglifam placebo-matching tablets, orally, twice daily for up to 12 weeks.
Receives: Drug: Placebo to fasiglifam
Fasiglifam 25 mg BIDExperimentalFasiglifam 25 mg tablets, orally, twice daily (BID) for up to 12 weeks.
Receives: Drug: Fasiglifam
Fasiglifam 50 mg QD +Placebo QDExperimentalFasiglifam 50 mg tablets, orally once daily (QD) and fasiglifam placebo-matching tablets, orally, once daily for up to 12 weeks.
Receives: Drug: Fasiglifam; Drug: Placebo to fasiglifam

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 12.

    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 12 or final visit relative to baseline.

    Measured: Baseline and Week 12

Secondary outcomes (1)

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

    The change between the FPG value collected at week 12 or final visit relative to baseline.

    Measured: Baseline and Week 12

Timeline

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

  1. First posted13 Nov 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJan 2014
  4. Study completionJan 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01982253
Sponsor's protocol ID
TAK-875_203
Other IDs
2013-000886-35, U1111-1146-1263
Status last verified
Aug 2016
First submitted
5 Nov 2013
Last updated
7 Oct 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fasiglifam in people with Type 2 Diabetes Mellitus, run by Takeda at 88 sites in 7 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 9 inclusion and 21 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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Slovakia, Bulgaria, Poland, Romania and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 Oct 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 12. (time frame: Baseline and Week 12). 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 NCT01982253.

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 7 Oct 2016.

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