Efficacy and Safety of TAK-875 in Subjects With Type 2 Diabetes Mellitus

March 13, 2016 updated by: Takeda

A Phase 2, Randomized, Double-Blind, Double-Dummy Placebo-and Active-Controlled, Multicenter Study to Determine the Efficacy and Safety of TAK-875 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine the safety and efficacy of multiple doses of TAK-875, once daily (QD), in subjects with Type 2 Diabetes Mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

TAK-875 is under clinical development for the treatment of type 2 diabetes mellitus in humans. Non-clinical as well as Phase I clinical data suggest that TAK-875 stimulates insulin secretion only at elevated blood glucose levels.

This study is being conducted to study glycemic effects and safety of TAK-875 compared with placebo and glimepiride in subjects with type 2 diabetes who are inadequately controlled on a stable dose of metformin as monotherapy.

Subjects participating in this study are required to fast for 8 hours prior to each study visit, and will be educated in recognition and self-management of hypoglycemia. In addition, during this Run-in Period compliance with study medication will be documented. Subjects who are less than 80% or more than120% compliant with the single-blind, placebo regimen during the run-in period will not be randomized.

At the conclusion of the Run-in period, appropriate subjects will be randomized into the 12 week double-blind treatment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
426

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • Guatemala, Guatemala
  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
      • Zapopan, Jalisco, Mexico
    • Morelos
      • Cuernavaca, Morelos, Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
    • Tamaulipas
      • Tampico, Tamaulipas, Mexico
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Hoover, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Anaheim, California, United States
      • Burlingame, California, United States
      • Chula Vista, California, United States
      • Fresno, California, United States
      • Los Angeles, California, United States
      • Los Gatos, California, United States
      • Norwalk, California, United States
      • Orange, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Pueblo, Colorado, United States
    • Florida
      • Boca Raton, Florida, United States
      • Clearwater, Florida, United States
      • Hialeah, Florida, United States
      • Jupiter, Florida, United States
      • Miami, Florida, United States
      • New Port Richey, Florida, United States
      • Ocala, Florida, United States
      • Panama City, Florida, United States
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Sandy Springs, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Chicago, Illinois, United States
      • La Grange, Illinois, United States
    • Louisiana
      • Sunset, Louisiana, United States
    • Maine
      • Portland, Maine, United States
    • Maryland
      • Parkville, Maryland, United States
      • Rockville, Maryland, United States
    • Michigan
      • Southfield, Michigan, United States
    • Mississippi
      • Olive Branch, Mississippi, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Berlin, New Jersey, United States
      • Camden, New Jersey, United States
    • New York
      • West Seneca, New York, United States
    • North Carolina
      • Asheboro, North Carolina, United States
      • Burlington, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Morehead City, North Carolina, United States
      • Statesville, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Carlisle, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Perrysburg, Ohio, United States
    • Oklahoma
      • Norman, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
      • Tipton, Pennsylvania, United States
    • Rhode Island
      • Cranston, Rhode Island, United States
    • South Carolina
      • Peak, South Carolina, United States
      • Taylors, South Carolina, United States
      • Varnville, South Carolina, United States
    • Texas
      • Corpus Christi, Texas, United States
      • Hurst, Texas, United States
      • North Richland Hills, Texas, United States
      • Odessa, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Draper, Utah, United States
      • Salt Lake City, Utah, United States
    • Washington
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant meets 1 of the following criteria:

    • A historical diagnosis of type 2 diabetes mellitus without the chronic use of antidiabetic therapy within 8 weeks prior to Screening, and with at least an 8-week documented history of a diet and exercise plan at Screening.
    • A historical diagnosis of mellitus and stable on at least 1500 mg per day or the respective (individually) maximal tolerated dose of metformin as monotherapy for at least 2 months prior to Screening.
  • Has a glycosylated hemoglobin level at Screening between 7.5% and 10.0%, inclusive, if on metformin and greater than or equal to 7.5% to less than 11% if treated with diet and exercise alone.
  • Has a fasting plasma glucose level less than 260 mg/dL, at Screening.
  • Has a fasting C-peptide concentration greater than or equal to 0.8 ng/mL at Screening.
  • If participant takes any chronic medications, the dose of these medications must have been stable (no change in dose or drug) for at least 4 weeks prior to Screening.
  • Participant's body mass index at Screening is greater than or equal to 23 and less than or equal to 45 kg/m2.
  • Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations.
  • Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study and for 1 month after the last dose of study drug.
  • Compliance with single-blind study medication during the Run-in Period is at least 80% and does not exceed 120% based on tablet counts performed by the study staff.

Exclusion Criteria:

  • Has systolic blood pressure greater than 160 mm Hg or diastolic pressure greater than 100 mm Hg at Screening or Baseline (as confirmed by repeat measurement 30 minutes after initial measurement).
  • Has history of cancer that has been in remission for less than 5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
  • Has a creatine phosphokinase level greater than or equal to 5 times the upper limit of normal at Screening.
  • Has a hemoglobin level of less than or equal to 12 g/dL (120 gm/L) for men and less than or equal to 10 g/dL (100 gm/L) for women at Screening.
  • Has alanine aminotransferase and aspartate aminotransferase levels greater than or equal to 2.5 times upper limit of normal at Screening.
  • Has a total bilirubin level greater than or equal to 1.5 mg/dL at Screening.
  • The subject has a serum triglyceride concentration greater than or equal to 400 mg/dL at Screening.
  • Has an estimated glomerular filtration rate less than or equal to 60 mL/min using the Modification of Diet in Renal Disease equation at Screening.
  • Has abnormal thyroid-stimulating hormone levels.
  • Has a positive test result for hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus.
  • Has macro-albuminuria at Screening
  • Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
  • Has diabetic gastroparesis that in the investigator's opinion is moderate or severe and hence may impair absorption of study medication.
  • Has 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 6 months prior or at Screening.
  • Has a history of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
  • Received treatment with probucol within 1 year of randomization.
  • Donated or received any blood products within 12 weeks prior to Screening.
  • Received treatment for more than 7 days within 4 weeks or 8 weeks (depending on the medication) prior to Screening.
  • Is on any insulin treatment.
  • Received any investigational drug within 4 weeks prior to Screening.
  • Is hypersensitive to TAK-875, its excipients or glimepiride.
  • Has a history of drug abuse or a history of alcohol abuse within 2 years prior to Screening.
  • 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.

  • Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

    • Probucol
    • Chronically used insulin
    • Chronically used oral or parenteral glucocorticoids
    • Chronically used over-the-counter or prescription weight-loss medications and/or Orlistat Niacin more than 200 mg/day, including niacin-containing products such as Advicor®
    • Chronically used peroxisome proliferator-activated receptor agonists, ezetimibe, oral or injectable hypoglycemic agents other than metformin bile-acid binding agents such as cholestyramine and colesevelam
    • Investigational medications
    • Warfarin and phenytoin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo QD
Drug: Placebo
TAK-875 placebo-matching tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Experimental: TAK-875 25 mg QD
Drug: TAK-875
TAK-875 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 50 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 100 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Drug: TAK-875
TAK-875 200 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Experimental: TAK-875 50 mg QD
Drug: TAK-875
TAK-875 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 50 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 100 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Drug: TAK-875
TAK-875 200 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Experimental: TAK-875 6.25 mg QD
Drug: TAK-875
TAK-875 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 50 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 100 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Drug: TAK-875
TAK-875 200 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Experimental: TAK-875 100 mg QD
Drug: TAK-875
TAK-875 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 50 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 100 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Drug: TAK-875
TAK-875 200 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Experimental: TAK-875 200 mg QD
Drug: TAK-875
TAK-875 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 50 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.
Drug: TAK-875
TAK-875 100 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Drug: TAK-875
TAK-875 200 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Active Comparator: Glimepiride 2 mg or 4mg QD
Drug: Glimepiride
TAK-875 placebo-matching tablets and Glimepiride 2 mg or 4mg, capsules, orally, once daily for up to 12 weeks.
Other Names:
  • Amaryl®
  • Glyree

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Glycosylated Hemoglobin at Week 12.
Time Frame: Baseline and Week 12
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Fasting Plasma Glucose at Week 12.
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in Body Weight at Week 12.
Time Frame: Baseline and Week 12
Baseline and Week 12
Incidence of Hypoglycemia During Double-Blind Treatment Period.
Time Frame: Per Occurrence (up to 12 weeks)
Per Occurrence (up to 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-875_201
  • U1111-1111-1019 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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