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Diabetes Mellitus, Type 2Phase 2NCT01414920

Efficacy and Safety of TAK-875 in Combination With Sitagliptin in Participants With Type 2 Diabetes Mellitus

A Phase 2 study testing TAK-875, Sitagliptin and TAK-875 and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Takeda at 80 sites in United States.

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 efficacy and safety of TAK-875, once daily (QD), in combination with sitagliptin QD in participants with type 2 diabetes mellitus (T2DM). 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, Sitagliptin and TAK-875 and Sitagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
368 participants
Where
80 sitesUnited States
Study dates
Aug 2011to Aug 2012
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

  • 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.
  • The participant has either:
  • A historical diagnosis of Type 2 Diabetes (T2DM) without the chronic use (defined as >7 days) of anti-diabetic therapy within 8 weeks prior to Screening, and with at least an 8-week documented history of a diet and exercise plan at Screening OR,
  • A historical diagnosis of T2DM and stable on at least 1500 mg per day (or maximum tolerated dose) of metformin as monotherapy for at least 8 weeks at Screening. Participants on a stable dose of metformin who enter the study will continue on the same dose of metformin throughout the duration of the study.
  • The participant is a man or woman and aged 18 to 80 years, inclusive.
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  • The participant's body mass index (BMI) (kg/m2) at Screening is ≥23 and ≤45.
  • The participant has an glycosylated hemoglobin (HbA1c) level at Screening between 7.5% and 10.0%, inclusive, if on metformin and between 7.5% to 10.9%, inclusive, if treated with diet and exercise alone.
  • The participant has a fasting plasma glucose level <14.4 mmol/L (<260 mg/dL), at Screening.
  • The participant has a fasting C-peptide concentration ≥0.26 nmol/L (≥0.8 ng/mL) at Screening.
  • If the participant takes any chronic, non-excluded medications, the dose of these medications must have been stable (no change in dose or drug) for at least 4 weeks prior to Screening.
  • The participant is able and willing to monitor their glucose levels with a home glucose monitor and consistently record his or her own blood glucose concentrations according to the given instructions.
  • A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
  • A female participant of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) pregnancy test at Screening (Visit 1) and at Placebo Run-in (Visit 2). A negative urine HCG pregnancy test is also required at Randomization (Visit 3), prior to administration of the first dose of double-blind study medication.
  • The participant's compliance with single-blind study medication during the run-in phase is at least 80% and does not exceed 120% based on tablet counts performed by the study staff.

Who cannot join

  • The participant has received any investigational compound within 4 weeks prior to Screening.
  • The participant has been enrolled in a previous TAK-875 study.
  • The participant 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.
  • The participant has a history of hypersensitivity or allergies to TAK-875 or sitagliptin, or their excipients.
  • The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit.
  • The participant 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).
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  • The participant has systolic blood pressure ≥150 mm Hg or diastolic pressure ≥90 mm Hg at Screening (Visit 1) or Baseline (Visit 3) (as confirmed by repeat measurement 30 minutes after initial measurement).
  • The participant has a creatine phosphokinase (CPK) level ≥5x the upper limit of normal (ULN) at Screening.
  • The participant has a hemoglobin level of ≤12 g/dL (120 gm/L) for men and ≤10 g/dL (100 gm/L) for women at Screening.
  • The participant has ALT and/or AST levels ≥2.5x ULN at Screening.
  • The participant has a total bilirubin level > ULN at Screening.
  • The participant has a serum triglyceride concentration ≥4.5 mmol/L (≥400 mg/dL) at Screening.
  • The participant has an estimated glomerular filtration rate ≤60mL/min using the Modification of Diet in Renal Disease (MDRD) equation at Screening.
  • The participant has a documented history or concurrent signs of uncontrolled (not euthyroid) thyroid disease (eg, autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active thyroid nodules).
  • The participant has a history of pancreatitis.
  • The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
  • The participant has a history of gastric bypass surgery or has diabetic gastroparesis that in the investigator's opinion is moderate or severe and hence may impair absorption of study medication.
  • The participant has 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 6 months prior or at Screening.
  • The participant has a history of any hemoglobinopathy that may affect determination of HbA1c.
  • The participant has a positive test result for hepatitis B surface antigen and antibody to hepatitis C virus, and/or has known history of human immunodeficiency virus at Screening.
  • The participant has donated or received any blood products within 12 weeks prior to Screening.
  • The participant received medication prior to Screening as listed in the excluded Medications section.
  • If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate an ova during such time period.
  • If male, the participant intends to donate sperm during the course of this study or for 30 days thereafter.
  • The participant 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

80 sites in 1 country.

80 sites in 1 country

United States80 sites

  • Study site

    Akron, Ohio

  • Study site

    Atlanta, Georgia

  • Study site

    Bangor, Maine

  • Study site

    Berlin, New Jersey

  • Study site

    Birmingham, Alabama

  • Study site

    Boise, Idaho

  • Study site

    Brandon, Florida

  • Study site

    Brimingham, Alabama

  • Study site

    Brockton, Massachusetts

  • Study site

    Brooklyn, New York

  • Study site

    Broomall, Pennsylvania

  • Study site

    Buena Park, California

  • Study site

    Buffalo, New York

  • Study site

    Calabash, North Carolina

  • Study site

    Chandler, Arizona

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chelsea, Michigan

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Ohio

  • Study site

    Cranston, Rhode Island

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Crossville, Tennessee

  • Study site

    Dallas, Texas

  • Study site

    DeLand, Florida

  • Study site

    Elkridge, Maryland

  • Study site

    Feasterville, Pennsylvania

  • Study site

    Fleetwood, Pennsylvania

  • Study site

    Fuquay-Varina, North Carolina

  • Study site

    Glendale, Arizona

  • Study site

    Green Valley, Arizona

  • Study site

    Hallandale, Florida

  • Study site

    Hialeah, Florida

  • Study site

    Houston, Texas

  • Study site

    Irvine, California

  • Study site

    Irving, Texas

  • Study site

    Jupiter, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kingsport, Tennessee

  • Study site

    Lakewood, Colorado

  • Study site

    Lexington, Kentucky

  • Study site

    Longwood, Florida

  • Study site

    Louisville, Kentucky

  • Study site

    Lyndhurst, Ohio

  • Study site

    Margate City, New Jersey

  • Study site

    Marion, Ohio

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Miami Lakes, Florida

  • Study site

    Morehead City, North Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    North Richland Hills, Texas

  • Study site

    Norwalk, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Orlando, Florida

  • Study site

    Paramount, California

  • Study site

    Pearland, Texas

  • Study site

    Pembroke Pines, Florida

  • Study site

    Portland, Oregon

  • Study site

    Rancho Cucamonga, California

  • Study site

    Roswell, Georgia

  • Study site

    San Antonio, Texas

  • Study site

    San Ramon, California

  • Study site

    Seattle, Washington

  • Study site

    Spring Valley, California

  • Study site

    St. Petersburg, Florida

  • Study site

    Suwanee, Georgia

  • Study site

    Tampa, Florida

  • Study site

    Tempe, Arizona

  • Study site

    Toms River, New Jersey

  • Study site

    Tucson, Arizona

  • Study site

    Valparaiso, Indiana

  • Study site

    Vista, California

  • Study site

    Walnut Creek, California

  • Study site

    Westlake Village, California

  • Study site

    Willoughby Hills, Ohio

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Placebo-Controlled, Factorial, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of 25 mg and 50 mg of TAK-875 in Combination With Sitagliptin 100 mg in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), in combination with sitagliptin QD in participants with type 2 diabetes mellitus (T2DM).

Read the detailed description

TAK-875 is being developed at Takeda Global Research and Development, Inc. as an adjunct to diet and exercise to improve glycemic control in patients with T2DM.

Sitagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) approved as an adjunct to diet and exercise to improve glycemic control in adults with T2DM.

This study will investigate the effects of the combination of TAK-875 with a DDP-4 inhibitor on glycosylated hemoglobin reduction.

Being tested
Placebo, TAK-875, Sitagliptin, TAK-875 and Sitagliptin
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.

  • PlaceboDrug

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

  • TAK-875Drug

    TAK-875 25 mg, tablets, orally, once daily for up to 12 weeks.

  • TAK-875Drug

    TAK-875 50 mg, tablets, orally, once daily for up to 12 weeks.

  • SitagliptinDrug

    Also called Januvia

    Sitagliptin 100 mg, tablets, orally, once daily for up to 12 weeks.

  • TAK-875 and SitagliptinDrug

    Also called Januvia

    TAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks.

  • TAK-875 and SitagliptinDrug

    Also called Januvia

    TAK-875 50 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks.

Study groups in NCT01414920
Study groupRoleWhat they receive
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo
TAK-875 25 mg QDExperimentalNot described
Receives: Drug: TAK-875
TAK-875 50 mg QDExperimentalNot described
Receives: Drug: TAK-875
Sitagliptin 100 mg QDExperimentalNot described
Receives: Drug: Sitagliptin
TAK-875 25 mg QD + Sitagliptin 100 mg QDExperimentalNot described
Receives: Drug: TAK-875 and Sitagliptin
TAK-875 50 mg QD + Sitagliptin 100 mg QDExperimentalNot described
Receives: Drug: TAK-875 and Sitagliptin

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)

    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 12 relative to baseline.

    Measured: Baseline and Week 12.

Secondary outcomes (1)

  1. Change from Baseline in Fasting Plasma Glucose

    The change between the fasting plasma glucose value collected at week 12 relative to baseline.

    Measured: Baseline and Week 12.

Timeline

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

  1. First posted11 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2012
  4. Study completionAug 2012

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
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01414920
Sponsor's protocol ID
TAK-875_202
Other IDs
U1111-1115-5044
Status last verified
Mar 2016
First submitted
10 Aug 2011
Last updated
4 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-875, Sitagliptin and TAK-875 and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Takeda at 80 sites in United States.

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 16 inclusion and 25 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 4 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 80 sites in United States. 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 (HbA1c) (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 NCT01414920.

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 4 Apr 2016.

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