TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes

NCT01829464 | Terminated Phase 3 Results DMC

• 2 other identifiers: TAK-875_303U1111-1124-2270
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 86

Brief Summary

The purpose of this study is to evaluate the effect of TAK-875 (fasiglifam) in combination with sitagliptin on glycemic control in adults with type 2 diabetes.

Conditions

Diabetes

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 24

  The change in the value of HbA1c (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.

  Baseline and Week 24

Secondary Outcomes (2)

• Percentage of Participants With HbA1c <7%

  Week 24

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

Study Arms (3)

Placebo

PLACEBO COMPARATOR

TAK-875 placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up 24 weeks.

Drug: Placebo

TAK-875 25 mg

EXPERIMENTAL

TAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up to 24 weeks

Drug: TAK-875

TAK-875 50 mg

EXPERIMENTAL

TAK-875 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up to 24 weeks

Drug: TAK-875

Interventions

Placebo DRUG

TAK-875 placebo-matching tablets

Placebo

TAK-875 DRUG

TAK-875 tablets

TAK-875 25 mg

Eligibility Criteria

• Age: 18 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 is male or female and aged 18 years or older with a historical diagnosis of T2DM.
• The participant meets one of the following criteria:
• The participant has an HbA1c between 7.5% and 10.5%, inclusive and has been taking a stable dose of sitagliptin 100 mg for at least 8 weeks, with or without metformin, prior to the Screening Visit. A participant who is taking metformin must have received a stable daily dose (≥1500 mg or documented maximum tolerated dose \[MTD\]) for at least 8 weeks before Screening. This participant will enter the 2-week single-blind Placebo Run-In Period according to Study Schedule A, or;

You may not qualify if:

• Note: An enrollment cap may be applied to ensure no more than approximately 20% of randomized participants are receiving a DPP-IV inhibitor without metformin at baseline.
• The participant has had no treatment with antidiabetic agents other than DPP-IV inhibitors and metformin within 2 months prior to Screening (Exception: if a participant has received other antidiabetic therapy for ≤7 consecutive days within the 2 months prior to Screening).
• The participant has a body mass index (BMI) ≤45 kg/m2 at Screening.
• Participants regularly using other, 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 participant 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.
• The participant is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete participant diaries.
• Has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within 3 months prior to Screening.
• Has been randomized into a previous TAK-875 study.
• 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.
• Donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
• Has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at the Screening Visit.
• Has history of cancer that has been in remission for \<5 years prior to Screening. (Exception: A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.)
• Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2.0x the upper limit of normal (ULN) at Screening.
• Has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome, they will be allowed with an elevated bilirubin level per the investigator's discretion.
• Has a serum creatinine ≥1.5 mg/dL (≥133 μmol/L) \[males\] and ≥1.4 mg/dL (≥124 μmol/L) \[females\] and/or estimated glomerular filtration rate (GFR) \<60 mL/min/1.73m\^2 at Screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (86)

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Birmingham, Alabama, United States

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Dothan, Alabama, United States

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Muscle Shoals, Alabama, United States

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Phoenix, Arizona, United States

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Anaheim, California, United States

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El Cajon, California, United States

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Long Beach, California, United States

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Modesto, California, United States

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North Hollywood, California, United States

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Norwalk, California, United States

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Pismo Beach, California, United States

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San Diego, California, United States

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Vista, California, United States

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West Hills, California, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Cocoa, Florida, United States

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Doral, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Woodstock, Georgia, United States

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Boise, Idaho, United States

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Meridian, Idaho, United States

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Apex Medical Research, MI, Inc

Chicago, Illinois, 60616, United States

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Chicago, Illinois, United States

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Avon, Indiana, United States

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Greenfield, Indiana, United States

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Muncie, Indiana, United States

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Council Bluffs, Iowa, United States

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Topeka, Kansas, United States

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Owensboro, Kentucky, United States

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Oxon Hill, Maryland, United States

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Fall River, Massachusetts, United States

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St Louis, Missouri, United States

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Washington, Missouri, United States

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Omaha, Nebraska, United States

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Nashua, New Hampshire, United States

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Elizabeth, New Jersey, United States

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Haddon Heights, New Jersey, United States

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Albany, New York, United States

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Rosedale, New York, United States

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Calabash, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Morganton, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Dayton, Ohio, United States

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Maumee, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Feasterville, Pennsylvania, United States

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Harleysville, Pennsylvania, United States

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Levittown, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Fort Mill, South Carolina, United States

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Greer, South Carolina, United States

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Spartanburg, South Carolina, United States

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Crossville, Tennessee, United States

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Knoxville, Tennessee, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Katy, Texas, United States

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Lewisville, Texas, United States

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McKinney, Texas, United States

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New Braunfels, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Tomball, Texas, United States

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Salt Lake City, Utah, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

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Salta, Salta Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Lima, Peru

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Related Publications (1)

• 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.

  PMID: 30880443 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

TAK-875

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Study Officials

• Medical Director, MD

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: April 9, 2013
• First Posted: April 11, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 1, 2016
• Results First Posted: June 1, 2016

Record last verified: 2016-04

Locations

US (82); AR (3); PE (1)