Randomized, multicenter study testing the safety and effectiveness of the investigational drug TAK-875 Fasiglifam administered once or twice daily in subjects with type 2 diabetes.
- Conditions
- Type 2 diabetes mellitus (T2DM)MedDRA version: 14.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-000886-35-SK
- Lead Sponsor
- Takeda Development Centre Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Main Criteria for Inclusion:
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 an HbA1c level =7.0% and =10.0% and FPG =270 mg/dL (15.0 mmol/L) at Screening.
5. The subject has a body mass index =45 kg/m2 at Screening.
6. The subject 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 subject has received other antidiabetic therapy for =7 days in total within the 2 months prior to Screening Visit).
7. Subjects regularly using other, nonexcluded 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 medications 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. A female subject 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.
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 308
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 92
Main Criteria for Exclusion:
1. The subject received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within the 3 months prior to Screening.
2. The subject was randomized into a previous fasiglifam study
3. The subject is an immediate family member, study site employee, or is in a dependant 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. 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 g/L) for males and =10 g/dL (=100 g/L) for females at Screening.
6. The subject has a systolic blood pressure =160 mm Hg or diastolic 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 alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0× 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 (=133µmol/L) [males] and =1.4 mg/dL (=124 µmol/L) [females] and/or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 at Screening.
11. The subject has uncontrolled thyroid disease as determined by the investigator.
12. The subject has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
13. The subject had gastric banding, or gastric bypass surgery within 1 year prior to Screening.
14. The subject has a known history of infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
15. The subject 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. The subject has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of fasiglifam.
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 as listed in Section 7.4, Excluded Medications and Treatments.
19. If female, the subject 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of fasiglifam 25 mg BID and fasiglifam 50 mg QD on glycemic control over a 12-week treatment period in subjects with T2DM who are inadequately controlled on diet and exercise alone.;Secondary Objective: To evaluate the safety and tolerability of fasiglifam 25 mg BID and fasiglifam 50 mg QD.;Primary end point(s): Change from baseline in HbA1c at Week 12.;Timepoint(s) of evaluation of this end point: Timepoint for evaluation of primary endpoint will be week 12.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline in FPG at Week 12.;Timepoint(s) of evaluation of this end point: Timepoint for evaluation of secondary endpoint will be week 12.