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Type 2 Diabetes MellitusPhase 3GRAND-307NCT01647542

Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes

A Phase 3 study testing TAK-875 in people with Type 2 Diabetes Mellitus, run by Takeda at 51 sites in 5 countries.

Terminated

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

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific adults 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
Type 2 Diabetes Mellitus
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
393 participants
Where
51 sitesin 5 countries
Study dates
Oct 2012to 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 patient is capable of understanding and complying with protocol requirements.
  • The patient or, when applicable, the patient'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, aged at least 18 years or over the legal age of consent in countries where that is greater than 18 years, with a historical diagnosis of T2DM.
  • Has an HbA1c of 7.0% to 10.0%, inclusive at screening, and has been treated with diet and exercise for at least 3 months.
  • Has a body mass index (BMI) of ≤45 kg/m^2 at screening.
  • Patients regularly using, 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 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.
  • 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.

Who cannot join

  • Is unable to understand the official language (verbal or written) of the country for which a certified translation of the approved informed consent is available.
  • 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.
  • Has hemoglobin a level ≤12 g/dL (≤120 g/L) (males) and ≤10 g/dL (≤100 g/L) (females) at the Screening Visit.
  • Has a history of any hemoglobinopathy that may affect determination of HbA1c.
  • Donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
  • Has systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening or Baseline (If the patient meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after initial measurement and decision will be made based on the second measurement).
Show all 24Show fewer
  • Had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram, cerebrovascular accident or transient ischemic attack within 3 months prior or at Screening.
  • Has a serum creatinine level of ≥1.5 mg/dL (males) and ≥1.4 mg/dL (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 a history or treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
  • Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x the upper limit of normal range (ULN) at Screening.
  • Has a total bilirubin level greater than the ULN at Screening. Exception: if a patient has documented Gilbert's Syndrome, they will be allowed with an elevated bilirubin level per the investigator's discretion.
  • Has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
  • If a patient has no known history of HBV infection, then a HBV Screening test panel should be done. If the test is positive and there is clinical manifestation of active infection per Investigator's diagnosis, then the patient should be excluded. In addition, if the patient is considered to need antiviral treatment, the patient should be excluded. (If the test results indicate only an hepatitis B surface antigen (HBsAg) carrier without any clinical manifestation of active infection, and no antiviral treatment is needed, then the patient could be enrolled provided all other criteria are met.)
  • 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 received any investigational compound within 30 days prior to Screening or has received >7 days of any antidiabetic agent within 3 months prior to Screening.
  • Has received TAK-875 in a previous clinical study.
  • Has a history of hypersensitivity, allergies or has had an anaphylactic reaction(s) to any component of TAK-875.
  • 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 prior to Screening 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.
  • If male, intends to donate sperm during the course of this study or for 30 days after final study medication dose.
  • 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

51 sites in 5 countries.

51 sites in 5 countries

China30 sites

  • Study site

    Beijing, Beijing Municipality

  • Study site

    Beijing

  • Study site

    Beijing,P.R., Beijing Municipality

  • Study site

    Changchun, Jilin

  • Study site

    Changchun City, Jilin Province, Jilin

  • Study site

    Changsha, Hunan

  • Study site

    Chengdu, Sichuan

  • Study site

    Chenzhou, Hunan

  • Study site

    Chongqing, Chongqing Municipality

  • Study site

    Chongqing

  • Study site

    Fuzhou, Fujian

  • Study site

    Guangzhou, Guangdong

  • Study site

    Guangzhou

  • Study site

    Guiyang, Guizhou

  • Study site

    Guiyang

  • Study site

    Harbin, Heilongjiang

  • Study site

    Hefei, Anhui

  • Study site

    Heilongjiang

  • Study site

    Nanjing, Jiangsu

  • Study site

    Nanjing

  • Study site

    Shanghai, Shanghai Municipality

  • Study site

    Shanghai

  • Study site

    Shijiazhuang, Hebei

  • Study site

    Suzhou, Jiangsu

  • Study site

    Tianjin, Tianjin Municipality

  • Study site

    Tianjin

  • Study site

    Wuhan, Hubei

  • Study site

    Xi'an, Shaanxi

  • Study site

    Xi’an, Shanxi

  • Study site

    Xiamen, Fujian

Other trials in China

South Korea6 sites

  • Study site

    Goyang-si, Gyeonggi-do

  • Study site

    Gyeonggi-do

  • Study site

    Incheon

  • Study site

    Seongnam-si, Gyeonggi-do

  • Study site

    Seoul

  • Study site

    Suwon, Gyeonggi-do

Other trials in South Korea

Australia5 sites

  • Study site

    Brookvale, New South Wales

  • Study site

    Elizabeth Vale, South Australia

  • Study site

    Maroubra, New South Wales

  • Study site

    Mosman, New South Wales

  • Study site

    Woy Woy, New South Wales

Other trials in Australia

New Zealand5 sites

  • Study site

    Auckland

  • Study site

    Hamilton

  • Study site

    Rotorua

  • Study site

    Tauranga

  • Study site

    Wellington

Other trials in New Zealand

Taiwan5 sites

  • Study site

    Kaohsiung City

  • Study site

    New Taipei City

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

Other trials in Taiwan

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 25 and 50mg Compared With Placebo in Asia Pacific Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific adults with type 2 diabetes mellitus (T2DM).

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.

The study will enroll approximately 750 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 25 mg once daily
  • TAK-875 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 at the same time each day throughout the study. All participants will be asked to record any time they have low blood sugar symptoms in a diary.

This multi-centre trial will be conducted the Asia Pacific region. The overall time to participate in this study is 30 weeks. Participants will make 13 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
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 tablets

  • TAK-875 PlaceboDrug

    TAK-875 placebo-matching tablets

Study groups in NCT01647542
Study groupRoleWhat they receive
TAK-875 25 mgExperimentalTAK-875 25 mg tablets, orally, once daily for up to 24 weeks.
Receives: Drug: TAK-875
TAK-875 50 mgExperimentalTAK-875 50 mg tablets, orally, once daily for up to 24 weeks.
Receives: Drug: TAK-875
PlaceboPlacebo comparatorTAK-875 placebo-matching tablets, orally, once daily for up to 24 weeks.
Receives: Drug: TAK-875 Placebo

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 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 (3)

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

    Measured: Week 24

  2. Change in Fasting Plasma Glucose From Baseline to Week 24

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

    Measured: Baseline and Week 24

  3. Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24

    The change between the value of glucose after a meal, measured following OGTT collected at Week 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, and C-peptide through blood samples drawn at 0, 30, 60, 90, and 120 minutes following consumption of a 75 gram (g) glucose beverage.

    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 posted23 Jul 2012 (estimated)
  2. Study startOct 2012
  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
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01647542
Sponsor's protocol ID
TAK-875_307
Other IDs
U1111-1129-7865, 1015011378
Acronym
GRAND-307
Status last verified
Oct 2015
First submitted
19 Jul 2012
Last updated
11 Nov 2015
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 Type 2 Diabetes Mellitus, run by Takeda at 51 sites in 5 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 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: stopped early, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in China, South Korea, Australia, New Zealand, Taiwan. 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 19 Aug 2015). 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 NCT01647542, 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 11 Nov 2015.

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