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Trial record 1 of 1 for:    TAK-875_203
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Fasiglifam 25 mg BID vs 50 mg QD

This study has been terminated.
(Due to potential concerns about liver safety (See Detailed Description))
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01982253
First received: November 5, 2013
Last updated: August 15, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Fasiglifam Drug: Placebo to fasiglifam Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind Parallel-Group, Multicenter Study to Evaluate the Glycemic Effects and Safety of Fasiglifam 25 mg Twice Daily and 50 mg Once Daily on Glycemic Control in Subjects With Type 2 Diabetes

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change From Baseline in HbA1c at Week 12. [ Time Frame: Baseline and 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.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [ Time Frame: Baseline and Week 12 ]
    The change between the FPG value collected at week 12 or final visit relative to baseline.


Enrollment: 10
Study Start Date: October 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Fasiglifam placebo-matching tablets, orally, twice daily for up to 12 weeks.
Drug: Placebo to fasiglifam
Fasiglifam placebo-matching tablets
Experimental: Fasiglifam 25 mg BID
Fasiglifam 25 mg tablets, orally, twice daily (BID) for up to 12 weeks.
Drug: Fasiglifam
Fasiglifam tablets
Other Name: TAK-875
Experimental: Fasiglifam 50 mg QD +Placebo QD
Fasiglifam 50 mg tablets, orally once daily (QD) and fasiglifam placebo-matching tablets, orally, once daily for up to 12 weeks.
Drug: Fasiglifam
Fasiglifam tablets
Other Name: TAK-875
Drug: Placebo to fasiglifam
Fasiglifam placebo-matching tablets

Detailed Description:

The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to treat people who have diabetes. This study will look at glycemic control in people who take fasiglifam.

The study will enroll approximately 400 patients. Participants will be randomly assigned (by chance) to one of the three treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Fasiglifam 25 mg twice a day
  • Fasiglifam 50 mg once daily
  • Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take one tablet twice each day throughout the study. All participants will be asked to record any time they have symptoms of hypoglycemia in a diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 18 weeks. Participants will make 9 visits to the clinic.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  2. 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.
  3. Is male or female and 18 years of age or older with a historical diagnosis of Type 2 Diabetes Mellitus (T2DM).
  4. 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.
  5. 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).
  6. Has a body mass index (BMI) ≤45 kg/m^2 at Screening.
  7. 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.
  8. 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.
  9. 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.

Exclusion Criteria:

  1. 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.
  2. Was randomized into a previous fasiglifam study.
  3. 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.
  4. Has donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
  5. Has a hemoglobin ≤12 g/dL (≤120 g/L) for males and ≤10 g/dL (≤100 g/L) for females at Screening.
  6. Has a systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening
  7. 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.
  8. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0× upper limit of normal (ULN) at Screening.
  9. 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.
  10. 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.
  11. Has uncontrolled thyroid disease as determined by the investigator.
  12. Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
  13. Had gastric banding, or gastric bypass surgery within one year prior to Screening.
  14. Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
  15. 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.
  16. Has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of fasiglifam.
  17. Has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
  18. Received excluded medications prior to Screening Visit or is expected to receive excluded medication.
  19. If female, is pregnant (confirmed by laboratory testing, ie, serum/urine human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
  20. The subject is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
  21. The subject 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 subject according to the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982253

  Show 88 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Medical Director, Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01982253     History of Changes
Other Study ID Numbers: TAK-875_203
2013-000886-35 ( EudraCT Number )
U1111-1146-1263 ( Registry Identifier: WHO Unique Trial Number )
Study First Received: November 5, 2013
Results First Received: October 21, 2015
Last Updated: August 15, 2016

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 22, 2017