Fasiglifam 25 mg BID vs 50 mg QD

NCT01982253 | Terminated Phase 2 Results

• 3 other identifiers: TAK-875_2032013-000886-35U1111-1146-1263
• Study Type: interventional
• Target: 10
• Locations: 7 countries
• Sites: 88

Brief Summary

To evaluate the efficacy of fasiglifam 25 mg twice daily (BID) and fasiglifam 50 mg once daily (QD) on glycemic control in adults with type 2 diabetes who are inadequately controlled on diet and exercise alone.

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 12.

  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 or final visit relative to baseline.

  Baseline and Week 12

Secondary Outcomes (1)

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

  Baseline and Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Fasiglifam placebo-matching tablets, orally, twice daily for up to 12 weeks.

Drug: Placebo to fasiglifam

Fasiglifam 25 mg BID

EXPERIMENTAL

Fasiglifam 25 mg tablets, orally, twice daily (BID) for up to 12 weeks.

Drug: Fasiglifam

Fasiglifam 50 mg QD +Placebo QD

EXPERIMENTAL

Fasiglifam 50 mg tablets, orally once daily (QD) and fasiglifam placebo-matching tablets, orally, once daily for up to 12 weeks.

Drug: Fasiglifam; Drug: Placebo to fasiglifam

Interventions

Fasiglifam DRUG

Fasiglifam tablets

Also known as: TAK-875

Fasiglifam 25 mg BID; Fasiglifam 50 mg QD +Placebo QD

Placebo to fasiglifam DRUG

Fasiglifam placebo-matching tablets

Fasiglifam 50 mg QD +Placebo QD; Placebo

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.
• Is male or female and 18 years of age or older with a historical diagnosis of Type 2 Diabetes Mellitus (T2DM).
• Has a glycosylated hemoglobin (HbA1c) level ≥7.0% and ≤10.0% and fasting plasma glucose (FPG) ≤270 mg/dL (15.0 mmol/L) at Screening Visit.
• Has been treated with diet and exercise but has not received treatment with antidiabetic agents within 12 weeks prior to Screening Visit (Exception: if a patient has received other antidiabetic therapy for ≤7 days in total within the 2 months prior to Screening Visit).
• Has a body mass index (BMI) ≤45 kg/m\^2 at Screening.
• If regularly using other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening Visit. However, as needed (PRN) use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
• Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete subject diaries.
• A female of childbearing potential who is sexually active with a non-sterilized 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.

You may not qualify if:

• Has received any investigational compound within 30 days prior to Screening Visit or has received an investigational anti-diabetic drug within the 3 months prior to Screening Visit.
• Was randomized into a previous fasiglifam 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, sibling) or may consent under duress.
• Has 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 g/L) for males and ≤10 g/dL (≤100 g/L) for females at Screening.
• Has a systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening
• 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.
• Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2.0× upper limit of normal (ULN) at Screening.
• Has a total bilirubin level greater than the ULN at Screening. Exception: if a patient has documented Gilbert's syndrome the patient will be allowed with an elevated bilirubin level per the investigator's discretion.
• Has a serum creatinine ≥1.5 mg/dL (≥133μmol/L) (males) and ≥1.4 mg/dL (≥124 μmol/L) (females) and/or estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m\^2 at Screening.
• Has uncontrolled thyroid disease as determined by the investigator.
• Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• Had gastric banding, or gastric bypass surgery within one year prior to Screening.
• Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
• 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 to or at Screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (88)

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Goodyear, Arizona, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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North Hollywood, California, United States

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Norwalk, California, United States

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Tustin, California, United States

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Boynton Beach, Florida, United States

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Coral Gables, Florida, United States

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Miami, 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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Franklin, 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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Metairie, Louisiana, United States

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Flint, Michigan, United States

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Albuquerque, New Mexico, 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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Salisbury, North Carolina, United States

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Maumee, Ohio, United States

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Norman, Oklahoma, United States

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Corvallis, Oregon, United States

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Portland, Oregon, 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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Carrollton, Texas, United States

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Dallas, Texas, United States

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Edinburg, Texas, United States

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Houstan, Texas, United States

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Houston, 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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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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Byala, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sevlievo, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Lodz, Poland

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Oświęcim, Poland

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Poznan, Poland

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Rzeszów, Poland

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Sobótka, Poland

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Torun, Poland

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Zgierz, Poland

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Baia Mare, Romania

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Bucharest, Romania

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Cluj-Napoca, Romania

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Iași, Romania

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Oradea, Romania

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Ploieşti, Romania

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Bardejov, 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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Lučenec, Slovakia

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Nitra, Slovakia

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Pezinok, Slovakia

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Sabinov, Slovakia

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Stropkov, Slovakia

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Svidník, Slovakia

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Štúrovo, Slovakia

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Simferopol, Ukraine

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Ternopil, Ukraine

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Vinnytsia, Ukraine

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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
• Organization: Takeda

clinicaltrialregistry@takeda.com

+1-877-825-3327

Study Officials

• Senior Medical Director, Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

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: November 5, 2013
• First Posted: November 13, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 7, 2016
• Results First Posted: October 7, 2016

Record last verified: 2016-08

Locations

BU (7); PL (7); SL (12); TW (4); UA (5); US (47); RO (6)