TAK-875, 50 mg CV Outcomes Study

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Type 2 diabetes mellitus (T2DM); MedDRA version: 14.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-001732-37-PL
• Lead Sponsor: Takeda Global Research & Development Centre (Europe) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-15
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Main Criteria for Inclusion:
1. Subjects who are 18 years of age or older;
2. Have a diagnosis of T2DM with an HbA1c between 7.0% and 10.5%, inclusive;
3. Subjects must have documentation of one of 3 High Risk factors (documented history of myocardial infarction, documented symptomatic peripheral arterial disease, or documented cerebrovascular disease), or have one of 5 Intermediate Risk factors (stable angina, multi vessel coronary disease, history of percutaneous coronary intervention, or specific clinical criteria with or without diabetic nephropathy);
4. Stable baseline ALT or AST levels;
5. Subject is able and willing to monitor glucose with a home glucose monitor and consistently record blood glucose concentrations in diaries;
6. If female of childbearing potential and sexually active with a non-sterilized male partner, agrees to use adequate contraception
throughout duration of the study and for 30 days after last dose of study medication.
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 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3000

Exclusion Criteria

Main Criteria for Exclusion:
1. Subjects who have received any investigational medication within 30 days prior to Screening or any investigational
antidiabetic medication or excluded medications within 3 months prior to Screening;
2. Have been randomized into a previous TAK-875 study;
3. Are an immediate family member, study site employee, or are in a dependant relationship with a study site employee involved in the conduct of this study;
4. Are diagnosed with type 1 diabetes mellitus or latent
autoimmune diabetes in adults;
5. Hemodynamically unstable, including severe heart failure (New York Heart Association Class IV);
6. Hospitalized at Screening Visit for the cardiovascular inclusion event;
7. Have an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) level >3.0x upper limit of normal (ULN); 8. Have a total bilirubin level >ULN at screening;
9. Have an estimated glomerular filtration rate (eGFR) =15 mL/min/1.73m2 based on Modification of Diet in Renal Disease (MDRD) calculation and is currently on dialysis or expected to start dialysis within the next 6 months;
10. Have uncontrolled thyroid disease;
11. Have a known history of infection with human
immunodeficiency virus (HIV);
12. Have a known active infection with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) requiring antiviral treatment;
13. Have a history of drug or alcohol abuse within the 2 years prior to Screening;
14. Have a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to TAK-875;
15. Have a history of cancer that has been in remission for <5 years prior to Screening, with the exception of basal cell carcinoma
or Stage 1 squamous cell carcinoma of the skin;
16. If female, is pregnant or lactating or intending to become pregnant or donate ova throughout the study period and within 1 month after.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified