Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes

NCT01456195 | Completed Phase 3 Results DMC

• 3 other identifiers: TAK-875_3012011-002741-35U1111-1124-2154
• Study Type: interventional
• Target: 421
• Locations: 8 countries
• Sites: 95

Brief Summary

The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (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 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.

  Baseline and Week 24

Secondary Outcomes (3)

• Incidence of HbA1c <7%

  Week 24

• Change From Baseline in Fasting Plasma Glucose

  Baseline and Week 24

• Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)

  Baseline and Week 24

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.

Drug: Placebo

Fasiglifam 25 mg

EXPERIMENTAL

Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.

Drug: Fasiglifam

Fasiglifam 50 mg

EXPERIMENTAL

Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.

Drug: Fasiglifam

Interventions

Placebo DRUG

Fasiglifam placebo-matching tablets

Placebo

Fasiglifam DRUG

Fasiglifam tablets

Fasiglifam 25 mg; Fasiglifam 50 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 18 years of age or older with a historical diagnosis of T2DM.
• The participant has been treated with only diet and exercise for at least 12 weeks prior to Screening and has an HbA1c concentration between 7.0 % and 10.5%, inclusive, at Screening.
• The participant has received ≤7 days of any antidiabetic agent within 12 weeks prior to Screening.
• The participant has a body mass index (BMI) ≤45 kg/m\^2 at Screening.
• Participants regularly using other, non-excluded medications must be on a stable dose for at least 4 weeks prior to Screening. However, as needed (PRN) use of prescription or over-the-counter medication is allowed at the discretion of the investigator.
• 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.
• A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely 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 has an HbA1c concentration between 7.0 and 10.5%, inclusive, and a fasting plasma glucose (FPG) ≤270 mg/dL (≤15.0 mmol/L) at Week -1 Visit. (If the participant does not qualify for randomization based on these criteria, the assessments may be repeated weekly, for a maximum of 2 additional weeks).
• The participant's overall compliance with single-blind study medication during the Placebo Run-in Period is at least 75% and does not exceed 125% based on tablet counts performed by the study staff.
• A female participant of childbearing potential must have a negative urine hCG pregnancy test at Baseline (Visit 4) prior to Randomization and 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 30 days prior to Screening or has received an investigational antidiabetic drug within 3 months prior to Screening.
• The participant has been randomized 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 (e.g., spouse, parent, child, or sibling; biological or legally adopted) or may consent under duress.
• The participant donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
• The participant has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening.
• 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 an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2.0x the upper limit of normal (ULN) at Screening.
• The participant has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome, the participant will be allowed with an elevated bilirubin level per the investigator's discretion.
• The participant 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.
• The participant has uncontrolled thyroid disease.
• The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• The participant has had gastric banding or gastric bypass surgery within one year prior to Screening.
• The participant has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
• The participant 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 3 months prior or at Screening.
• The participant has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875.

Sponsors & Collaborators

• Takeda: lead

Study Sites (95)

Unknown Facility

Dothan, Alabama, United States

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Muscle Shoals, Alabama, United States

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Goodyear, Arizona, United States

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Phoenix, Arizona, United States

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Long Beach, California, United States

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North Hollywood, California, United States

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Norwalk, California, United States

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Palm Springs, California, United States

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Pismo Beach, California, United States

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Boynton Beach, Florida, United States

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Bradenton, Florida, United States

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Coral Gables, Florida, United States

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Hialeah, Florida, United States

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Largo, Florida, United States

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New Port Richey, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Decatur, Georgia, 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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Lexington, Kentucky, United States

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Oxon Hill, Maryland, United States

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Flint, Michigan, United States

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Picayune, Mississippi, United States

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Omaha, Nebraska, United States

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Elizabeth, New Jersey, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Mooresville, North Carolina, United States

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Morganton, North Carolina, United States

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Raleigh, North Carolina, United States

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Maumee, Ohio, United States

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Oklahoma City, Oklahoma, 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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Greer, South Carolina, United States

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Crossville, Tennessee, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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El Pasco, 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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New Braunfels, Texas, United States

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San Antonio, Texas, United States

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Spring, 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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Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

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Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

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Corrientes, Corrientes Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Villa Cabrera, Córdoba Province, Argentina

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Mendoza, Mendoza Province, Argentina

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Byala, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Guatemala City, Guatemala

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Quetzaltenango, Guatemala

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Zacapa, Guatemala

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Budapest, Hungary

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Debrecen, Hungary

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Kecskemét, Hungary

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Komárom, Hungary

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Szikszó, Hungary

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Zalaegerszeg, Hungary

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Dolný Kubín, Slovakia

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Komárno, Slovakia

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Levice, Slovakia

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Pezinok, Slovakia

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Prievidza, Slovakia

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Trebišov, Slovakia

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Trenčín, Slovakia

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Žilina, Slovakia

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Dnipropetrovsk, Ukraine

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Odesa, Ukraine

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Simferopol, Ukraine

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Ternopil, Ukraine

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Vinnytsia, Ukraine

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Zaporizhzhia, Ukraine

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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, Type 2

Interventions

TAK-875

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Study Officials

• Senior Medical Director

  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: October 18, 2011
• First Posted: October 20, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 5, 2016
• Results First Posted: April 5, 2016

Record last verified: 2016-03

Locations

US (55); BU (5); HU (6); GU (3); ME (2); AR (6); SL (10); UA (8)