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Diabetes Mellitus, Type 2Phase 2NCT01007097

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

A Phase 2 study testing TAK-875 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Takeda at 71 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
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
426 participants
Where
71 sitesin 3 countries
Study dates
Dec 2009to Sep 2010
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

71 sites in 3 countries.

71 sites in 3 countries

United States64 sites

  • Study site

    Altoona, Pennsylvania

  • Study site

    Anaheim, California

  • Study site

    Asheboro, North Carolina

  • Study site

    Berlin, New Jersey

  • Study site

    Birmingham, Alabama

  • Study site

    Boca Raton, Florida

  • Study site

    Burlingame, California

  • Study site

    Burlington, North Carolina

  • Study site

    Camden, New Jersey

  • Study site

    Carlisle, Ohio

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Ohio

  • Study site

    Corpus Christi, Texas

  • Study site

    Cranston, Rhode Island

  • Study site

    Draper, Utah

  • Study site

    Fresno, California

  • Study site

    Hialeah, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Hoover, Alabama

  • Study site

    Hurst, Texas

  • Study site

    Jupiter, Florida

  • Study site

    La Grange, Illinois

  • Study site

    Las Vegas, Nevada

  • Study site

    Los Angeles, California

  • Study site

    Los Gatos, California

  • Study site

    Miami, Florida

  • Study site

    Morehead City, North Carolina

  • Study site

    New Port Richey, Florida

  • Study site

    Norman, Oklahoma

  • Study site

    North Richland Hills, Texas

  • Study site

    Norwalk, California

  • Study site

    Ocala, Florida

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Orange, California

  • Study site

    Panama City, Florida

  • Study site

    Parkville, Maryland

  • Study site

    Peak, South Carolina

  • Study site

    Pembroke Pines, Florida

  • Study site

    Perrysburg, Ohio

  • Study site

    Portland, Maine

  • Study site

    Pueblo, Colorado

  • Study site

    Rockville, Maryland

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Sandy Springs, Georgia

  • Study site

    Southfield, Michigan

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Statesville, North Carolina

  • Study site

    Sunset, Louisiana

  • Study site

    Tampa, Florida

  • Study site

    Taylors, South Carolina

  • Study site

    Tipton, Pennsylvania

  • Study site

    Tucson, Arizona

  • Study site

    Varnville, South Carolina

  • Study site

    West Seneca, New York

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Mexico6 sites

  • Study site

    Cuernavaca, Morelos

  • Study site

    Guadalajara, Jalisco

  • Study site

    Mexico City, Mexico City

  • Study site

    Monterrey, Nuevo León

  • Study site

    Tampico, Tamaulipas

  • Study site

    Zapopan, Jalisco

Other trials in Mexico

Guatemala1 site

  • Study site

    Guatemala City, Departamento de Guatemala

Other trials in Guatemala

About this study

Official title: 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.

Read the 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.

Being tested
TAK-875, Glimepiride, Placebo
Keywords
Diabetes Mellitus, Non Insulin Dependent, Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus, 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 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.

  • TAK-875Drug

    TAK-875 25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.

  • TAK-875Drug

    TAK-875 50 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.

  • TAK-875Drug

    TAK-875 100 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks

  • TAK-875Drug

    TAK-875 200 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks

  • GlimepirideDrug

    Also called Amaryl®, Glyree

    TAK-875 placebo-matching tablets and Glimepiride 2 mg or 4mg, capsules, orally, once daily for up to 12 weeks.

  • PlaceboDrug

    TAK-875 placebo-matching tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks

Study groups in NCT01007097
Study groupRoleWhat they receive
TAK-875 6.25 mg QDExperimentalNot described
Receives: Drug: TAK-875
TAK-875 25 mg QDExperimentalNot described
Receives: Drug: TAK-875
TAK-875 50 mg QDExperimentalNot described
Receives: Drug: TAK-875
TAK-875 100 mg QDExperimentalNot described
Receives: Drug: TAK-875
TAK-875 200 mg QDExperimentalNot described
Receives: Drug: TAK-875
Glimepiride 2 mg or 4mg QDActive comparatorNot described
Receives: Drug: Glimepiride
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Glycosylated Hemoglobin at Week 12.

    Measured: Baseline and Week 12

Secondary outcomes (3)

  1. Change from Baseline in Fasting Plasma Glucose at Week 12.

    Measured: Baseline and Week 12

  2. Change from Baseline in Body Weight at Week 12.

    Measured: Baseline and Week 12

  3. Incidence of Hypoglycemia During Double-Blind Treatment Period.

    Measured: Per Occurrence (up to 12 weeks)

Timeline

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

  1. First posted3 Nov 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionSep 2010
  4. Study completionSep 2010

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
426 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01007097
Sponsor's protocol ID
TAK-875_201
Other IDs
U1111-1111-1019
Status last verified
Mar 2016
First submitted
2 Nov 2009
Last updated
13 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Burant CF, Viswanathan P, Marcinak J, Cao C, Vakilynejad M, Xie B, Leifke E. TAK-875 versus placebo or glimepiride in type 2 diabetes mellitus: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2012 Apr 14;379(9824):1403-11. doi: 10.1016/S0140-6736(11)61879-5. Epub 2012 Feb 27.

    PubMed 22374408

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-875 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Takeda at 71 sites in 3 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 11 inclusion and 31 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: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Mexico, Guatemala. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 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 NCT01007097, 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 13 Apr 2016.

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