EUCTR2011-002741-35-HUActive, not recruitingNot Applicable
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared with Placebo in Subjects with Type 2 Diabetes - Comparison of TAK-875 with Placebo in Subjects with Type 2 Diabetes
Takeda Global Research & Development Centre (Europe) Ltd.0 sites462 target enrollmentStarted: January 23, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 462
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
- •2. The subject or, when applicable, the subject’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. The subject is male or female and 18 years of age or older with a historical diagnosis of T2DM.
- •4. The subject 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.
- •5. The subject has received =7 days of any antidiabetic agent within 12 weeks prior to Screening.
- •6. The subject has a body mass index (BMI) =45 kg/m2 at Screening.
- •7. Subjects 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.
- •8. The subject 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. Deleted
- •10. A female subject 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 383
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 79
Exclusion Criteria
- •1. The subject has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within 3 months prior to Screening.
- •2. The subject has been randomized in a previous TAK-875 study.
- •3. The subject 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.
- •4. The subject donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
- •5. The subject has a hemoglobin =12 g/dL (=120 gm/L) for males and =10 g/dL (=100 gm/L) for females at Screening.
- •6. The subject has a systolic blood pressure =160 mm Hg or diastolic blood pressure =95 mm Hg at Screening (If the subject meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).
- •7. The subject 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. The subject has an ALT and/or AST levels >2.0x the upper limit of normal (ULN) at Screening.
- •9. The subject has a total bilirubin level greater than the ULN at Screening. Exception: if a subject has documented Gilbert’s Syndrome, the subject will be allowed with an elevated bilirubin
- •level per the investigator’s discretion.
- •10. The subject has a serum creatinine =1.5 mg/dL (=133 µmol/L) [males] and =1.4 mg/dL (=124µmol/L)[females] and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at Screening.
- •11. The subject has uncontrolled thyroid disease
- •12. The subject has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
- •13. The subject has had gastric banding, or gastric bypass surgery within one year prior Screening.
- •14. The subject has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
- •15. The subject had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal ECG, cerebrovascular accident or transient ischemic attack within 3 months prior or at Screening.
- •16. The subject has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875.
- •17. The subject has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
- •18. The subject received excluded medications prior to Screening or is expected to receive excluded medication listed in Section 7.4, Excluded Medications.
- •19. If female, the subject is pregnant (confirmed by laboratory testing, ie, serum 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. Deleted
- •21. 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.
- •22. The subject has any other physical or psychiatric disease or condition that
Investigators
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