AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT01829477

Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes

A Phase 3 study testing TAK-875 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Takeda at 69 sites in 7 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 compared to placebo on glycemic control over a 24-week Treatment Period when used as an add-on to glimepiride in addition to diet and exercise. 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?
TAK-875 and Glimepiride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
69 sitesin 7 countries
Study dates
Apr 2013to Feb 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.
  • Male or female and aged 18 or older with a historical diagnosis of type 2 diabetes mellitus (T2DM).
  • Has a glycosylated hemoglobin (HbA1c) of 7.0% to10.0%, inclusive at screening, and has been treated with diet and exercise and a sulfonylurea for at least 12 weeks.
  • Has a body mass index (BMI) ≤45 kg/m2 at Screening.
  • Participants regularly using other, non-excluded medications, must be on a stable dose and regimen 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. Note: Participants who require initiation of a chronically administered medication(s) due to a disease or condition diagnosed at Screening must be re-screened after the new regimen has been stabilized.
  • A female of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug.
  • Is able and willing to monitor glucose with a sponsor-provided home glucose monitor and consistently record his or her own blood glucose concentrations and 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 participated in a previous TAK-875 study.
  • 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, 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 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening.
  • 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).
Show all 22Show fewer
  • 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 >2.0x 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, the participant will be allowed with an elevated bilirubin level per the investigator's discretion.
  • Has a serum creatinine ≥1.5 mg/dL (≥133 μmol/L) [if male] or ≥1.4 mg/dL (≥124 μmol/L) [if female] and/or estimated (based on Modification of Diet in Renal Disease [MDRD] calculation) glomerular filtration rate (GFR) <60 mL/min/1.73m2 (regardless of gender) 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 1 year prior to Screening.
  • Has known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency, which increases risk for hemolytic anemia by sulfonylurea treatment.
  • 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 or at Screening.
  • Has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875 or glimepiride.
  • 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 or is expected to receive excluded medication.
  • If female, the participant is pregnant (confirmed by laboratory testing, ie, 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.
  • 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

69 sites in 7 countries.

69 sites in 7 countries

United States38 sites

  • Study site

    Augusta, Georgia

  • Study site

    Boynton Beach, Florida

  • Study site

    Bradenton, Florida

  • Study site

    Chicago, Illinois

  • Study site

    Conyers, Georgia

  • Study site

    Coral Gables, Florida

  • Study site

    Flint, Michigan

  • Study site

    Fresno, California

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Hanleysville, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Lakewood, Colorado

  • Study site

    Las Vegas, Nevada

  • Study site

    Laurens, South Carolina

  • Study site

    Lexington, Kentucky

  • Study site

    Long Beach, California

  • Study site

    Manassas, Virginia

  • Study site

    Maumee, Ohio

  • Study site

    Miami, Florida

  • Study site

    Morehead City, North Carolina

  • Study site

    Morganton, North Carolina

  • Study site

    Muscle Shoals, Alabama

  • Study site

    Nashua, New Hampshire

  • Study site

    National City, California

  • Study site

    North Hollywood, California

  • Study site

    North Miami Beach, Florida

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Oxon Hill, Maryland

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Pismo Beach, California

  • Study site

    Rosedale, New York

  • Study site

    San Antonio, Texas

  • Study site

    Spring, Texas

  • Study site

    Tampa, Florida

  • Study site

    Tomball, Texas

  • Study site

    Uniontown, Pennsylvania

Other trials in United States

Poland10 sites

  • Study site

    Bialystok

  • Study site

    Gdansk

  • Study site

    Grodzisk Mazowiecki

  • Study site

    Kamieniec Ząbkowicki

  • Study site

    Lodz

  • Study site

    Oświęcim

  • Study site

    Poznan

  • Study site

    Puławy

  • Study site

    Rzeszów

  • Study site

    Zgierz

Other trials in Poland

Slovakia7 sites

  • Study site

    Banská Bystrica

  • Study site

    Bratislava

  • Study site

    Dolný Kubín

  • Study site

    Levice

  • Study site

    Lučenec

  • Study site

    Pezinok

  • Study site

    Svidník

Other trials in Slovakia

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Gödöllő

  • Study site

    Kistelek

  • Study site

    Komárom

  • Study site

    Zalaegerszeg

Other trials in Hungary

Bulgaria3 sites

  • Study site

    Gabrovo

  • Study site

    Plovdiv

  • Study site

    Sofia

Other trials in Bulgaria

Canada3 sites

  • Study site

    Oakville, Ontario

  • Study site

    Thornhill, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

Romania3 sites

  • Study site

    Baia Mare

  • Study site

    Ploieşti

  • Study site

    Timișoara

Other trials in Romania

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared With Placebo as an Add-on to Glimepiride in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the effect of TAK-875 compared to placebo on glycemic control over a 24-week Treatment Period when used as an add-on to glimepiride in addition to diet and exercise.

Read the 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 glycosylated hemoglobin (blood glucose combined with hemoglobin, also known as HbA1c) and blood sugar levels in people who take TAK-875 in addition to glimepiride and diet and exercise.

The study will enroll approximately 260 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. This multi-center trial will be conducted in North America and Europe. The overall time to participate in this study is up to 44 weeks and participants will make up to 17 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
TAK-875, TAK-875 Placebo, Glimepiride
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.

  • TAK-875Drug

    TAK-875 50 mg tablets

  • TAK-875 PlaceboDrug

    TAK-875 placebo-matching tablets

  • GlimepirideDrug

    Also called Amaryl

    Glimepiride tablet.

Study groups in NCT01829477
Study groupRoleWhat they receive
TAK-875 50 mgExperimentalTAK-875 50 mg tablet, orally, once daily and glimepiride 6 mg (or Maximum Tolerated Dose), tablets, orally, once daily for up to 24 weeks.
Receives: Drug: TAK-875; Drug: Glimepiride
PlaceboPlacebo comparatorTAK-875 placebo-matching tablet, orally, once daily and glimepiride 6 mg (or Maximum Tolerated Dose), tablets, orally, once daily for up to 24 weeks.
Receives: Drug: TAK-875 Placebo; Drug: Glimepiride

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) at Week 24

    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.

    Measured: Baseline and Week 24

Secondary outcomes (2)

  1. Percentage of Participants With HbA1c <7 % at Week 24.

    Measured: Week 24

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

    The change between the fasting plasma glucose value collected at week 24 or final visit 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 startApr 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01829477
Sponsor's protocol ID
TAK-875_309
Other IDs
2013-000007-17, U1111-1138-8680, 164539
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 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Takeda at 69 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 8 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 69 sites in United States, Poland, Slovakia, Hungary, Bulgaria 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 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 Glycosylated Hemoglobin (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 NCT01829477, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in