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

NCT01414920 | Completed Phase 2

• 2 other identifiers: TAK-875_202U1111-1115-5044
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 80

Brief 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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (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.

  Baseline and Week 12.

Secondary Outcomes (1)

• Change from Baseline in Fasting Plasma Glucose

  Baseline and Week 12.

Study Arms (6)

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

TAK-875 25 mg QD

EXPERIMENTAL

Drug: TAK-875

TAK-875 50 mg QD

EXPERIMENTAL

Drug: TAK-875

Sitagliptin 100 mg QD

EXPERIMENTAL

Drug: Sitagliptin

TAK-875 25 mg QD + Sitagliptin 100 mg QD

EXPERIMENTAL

Drug: TAK-875 and Sitagliptin

TAK-875 50 mg QD + Sitagliptin 100 mg QD

EXPERIMENTAL

Drug: TAK-875 and Sitagliptin

Interventions

Placebo DRUG

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

Placebo QD

TAK-875 DRUG

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

TAK-875 25 mg QD

Sitagliptin DRUG

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

Also known as: Januvia

Sitagliptin 100 mg QD

TAK-875 and Sitagliptin DRUG

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

Also known as: Januvia

TAK-875 25 mg QD + Sitagliptin 100 mg QD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (80)

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Birmingham, Alabama, United States

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Brimingham, Alabama, United States

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Chandler, Arizona, United States

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Glendale, Arizona, United States

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Green Valley, Arizona, United States

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Mesa, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Buena Park, California, United States

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Irvine, California, United States

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Norwalk, California, United States

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Paramount, California, United States

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Rancho Cucamonga, California, United States

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San Ramon, California, United States

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Spring Valley, California, United States

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Vista, California, United States

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Walnut Creek, California, United States

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Westlake Village, California, United States

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Colorado Springs, Colorado, United States

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Lakewood, Colorado, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Hallandale, Florida, United States

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Hialeah, Florida, United States

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Jupiter, Florida, United States

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Longwood, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Roswell, Georgia, United States

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Suwanee, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Valparaiso, Indiana, United States

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Crestview Hills, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Bangor, Maine, United States

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Elkridge, Maryland, United States

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Brockton, Massachusetts, United States

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Chelsea, Michigan, United States

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Kalamazoo, Michigan, United States

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Olive Branch, Mississippi, United States

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Berlin, New Jersey, United States

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Margate City, New Jersey, United States

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Toms River, New Jersey, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Calabash, North Carolina, United States

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Fuquay-Varina, North Carolina, United States

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Morehead City, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Lyndhurst, Ohio, United States

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Marion, Ohio, United States

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Willoughby Hills, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Broomall, Pennsylvania, United States

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Feasterville, Pennsylvania, United States

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Fleetwood, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Chattanooga, Tennessee, United States

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Crossville, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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North Richland Hills, Texas, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

TAK-875; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Sr. Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 11, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 4, 2016

Record last verified: 2016-03

Locations

US (80)