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Type 2 Diabetes MellitusPhase 3NCT02015780

Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis

A Phase 3 study testing Fasiglifam and Antihyperglycemic therapy in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Takeda at 30 sites in 7 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in participants with Type 2 Diabetes Mellitus (T2DM) and chronic kidney disease (CKD) stage 4 or 5 on dialysis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fasiglifam and Antihyperglycemic therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
30 sitesin 7 countries
Study dates
Dec 2013to Jan 2016
Phase
Phase 3
Are there results?
None posted in the registry

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 18 years of age or older with a historical diagnosis of Type 2 diabetes mellitus (T2DM).
  • Is on antihyperglycemic therapy that is acceptable by local practice guidelines, including any of the following alone or in combination: insulin, sulfonylurea, thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, meglitinides, alpha-glucosidase inhibitors or dipeptidyl peptidase-4 (DPP-4) inhibitors. Existing glucose-lowering therapy must have remained stable in regimen without significant changes in dosage based on investigator judgment for ≥8 weeks before study entry.
  • Has for ≥ 3 months prior to Screening, chronic kidney disease (CKD) stage 4 (defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m^2 by Modification of Diet in Renal Disease (MDRD) formula), or CKD stage 5 on dialysis (ie eGFR <15 ml/min/1.73 m^2 by MDRD formula).
  • Has an HbA1c level ≥7.5 and ≤10.5%, inclusive, and fasting plasma glucose <270 mg/dL (15.0 mmol/L) at Screening.
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  • Has a C-peptide level ≥ 0.33 mmol/L at Screening.
  • Has a body mass index (BMI) ≤45 kg/m^2 at Screening.
  • A female of childbearing potential who is sexually active with a non-sterilized 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.
  • 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 antihyperglycemic drug within the 3 months prior to Screening.
  • Was randomized into a previous fasiglifam (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, sibling) or may consent under duress.
  • Received any blood products within 12 weeks prior to Screening.
  • Has a hemoglobin ≤9 g/dL (≤90 g/L) at Screening.
  • Has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at Screening.
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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 >2.0 x upper limit of normal (ULN) at Screening.
  • Has a total bilirubin level greater than the ULN at Screening.
  • Has uncontrolled secondary hyperparathyroidism as determined by the investigator.
  • Has had any requirement for acute (<3 months) dialysis or initiated on dialysis within the previous 3 months, has CKD stage 4 with rapidly deteriorating kidney function likely to require renal replacement therapy (dialysis or kidney transplantation) within 12 months of enrollment (patients on dialysis must be on this procedure for at least 3 months, not less than 3 months).
  • Has uncontrolled thyroid disease as determined by the investigator.
  • Has had gastric banding, or gastric bypass surgery within 1 year prior to Screening.
  • Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  • Has a history of significant cerebrovascular and/or cardiovascular diseases including myocardial infarction, unstable angina, stroke, transient ischemic attack, New York Heart Association class III/IV congestive heart failure and/or left ventricular ejection fraction ≤40% within 12 months prior to 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 (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within 2 years prior to Screening.
  • Received excluded medications within 3 months prior to Screening or is expected to receive excluded medication within 12 months after enrollment.
  • If female, 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 patient according to the protocol.
  • To be eligible for randomization, each of the following additional criteria must be satisfied with a "yes" answer:
  • The subject has an HbA1c concentration ≥7.5% and ≤10.5%, and a FPG ≤270 mg/dL (15.0 mmol/L) at the Week -1 Visit. (If the subject does not qualify for randomization based on these criteria, the assessment may be repeated weekly, for a maximum of 2 additional weeks.)
  • The subject's compliance with the 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 site study staff.

Trial locations and contacts

30 sites in 7 countries.

30 sites in 7 countries

United States7 sites

  • Study site

    Charleston, South Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Rosedale, New York

  • Study site

    San Antonio, Texas

  • Study site

    Tampa, Florida

  • Study site

    Westminster, Colorado

  • Study site

    Whittier, California

Other trials in United States

Slovakia7 sites

  • Study site

    Banská Bystrica

  • Study site

    Bardejov

  • Study site

    Myjava

  • Study site

    Púchov

  • Study site

    Senica

  • Study site

    Svidník

  • Study site

    Trstená

Other trials in Slovakia

Hungary5 sites

  • Study site

    Baja

  • Study site

    Gyula

  • Study site

    Kaposvár

  • Study site

    Szigetvár

  • Study site

    Zalaegerszeg

Other trials in Hungary

Ukraine4 sites

  • Study site

    Donetsk

  • Study site

    Kyiv

  • Study site

    Ternopil

  • Study site

    Vinnytsia

Other trials in Ukraine

Bulgaria3 sites

  • Study site

    Pazardzhik

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

South Africa3 sites

  • Study site

    Bloemfontein, Free State

  • Study site

    Cape Town, Western Cape

  • Study site

    Worcester, Western Cape

Other trials in South Africa

Poland1 site

  • Study site

    Zamość

Other trials in Poland

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasiglifam (TAK-875) Compared to Placebo as Add-on to Preexisting Antihyperglycemic Therapy Over 16 Weeks With 36-week Extension in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or Stage 5 on Dialysis

To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in participants with Type 2 Diabetes Mellitus (T2DM) and chronic kidney disease (CKD) stage 4 or 5 on dialysis.

Read the detailed description

The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to treat people who have diabetes and chronic kidney disease. This study will look at glycemic control in people who take fasiglifam in addition to standard antihyperglycemic therapy.

The study will enroll approximately 164 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):

  • 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 in addition to their current antihyperglycemic therapy. All participants will be asked to record any time they have hypoglycemia signs and symptoms in a diary.

This multi-center trial will be conducted in the United States and European regions. The overall time to participate in this study is approximately 57 weeks.

Participants will make 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
Fasiglifam, Placebo, Antihyperglycemic therapy
Keywords
Drug therapy
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

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

  • PlaceboDrug

    Fasiglifam placebo-matching tablets

  • Antihyperglycemic therapyDrug

    Including any of the following alone or in combination: insulin, sulfonylurea, thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, meglitinides, alpha-glucosidase inhibitors or dipeptidyl peptidase-4 (DPP-4) inhibitors acceptable by local practice guidelines.

Study groups in NCT02015780
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFasiglifam placebo-matching tablets, once daily, and stable antihyperglycemic therapy for up to 16 weeks. Then Fasiglifam placebo-matching tablets, once daily and antihyperglycemic therapy, adjusted as necessary per the Investigator's discretion, for up to 36 weeks.
Receives: Drug: Placebo; Drug: Antihyperglycemic therapy
FasiglifamExperimentalFasiglifam 50 mg tablets, once daily and stable antihyperglycemic therapy for up to 16 weeks. Then Fasiglifam 50 mg tablets, once daily and antihyperglycemic therapy, adjusted as necessary per the Investigator's discretion, for up to 36 weeks.
Receives: Drug: Fasiglifam; Drug: Antihyperglycemic therapy

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 16

    The change from Baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 16.

    Measured: Baseline and Week 16

Secondary outcomes (3)

  1. Percentage of participants with HbA1c <7.5% at Week 16

    Measured: Week 16

  2. Change from Baseline in Fasting Plasma Glucose (FPG) at Week 16

    Measured: Baseline and Week 16

  3. Change from Baseline in Total Daily Dose of Insulin at Week 52

    Measured: Baseline and Week 52

Timeline

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

  1. First posted19 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionJan 2016 (estimated)
  4. Study completionJan 2016 (estimated)

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02015780
Sponsor's protocol ID
TAK-875_311
Other IDs
U1111-1146-5546, 2013-003414-40
Status last verified
Jan 2014
First submitted
13 Dec 2013
Last updated
27 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fasiglifam and Antihyperglycemic therapy in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Takeda at 30 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 10 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: withdrawn, as of the sponsor's last update on 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Slovakia, Hungary, Ukraine, 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?

The study was withdrawn before enrolling participants, so there are no results.

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 16 (time frame: Baseline and Week 16). 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 NCT02015780.

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 27 Jan 2014.

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