Comparison of TAK-875 to Placebo and Sitagliptin in Combination with Metformin in Subjects with Type 2 Diabetes

• Conditions: Type 2 diabetes mellitus (T2DM); MedDRA version: 16.0Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 16.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 16.0Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 16.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 16.0Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-001752-10-BG
• Lead Sponsor: Takeda Development Centre Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-28
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1078

Inclusion Criteria

Subject eligibility is determined according to the following criteria:
1. The subject is male or female and 18 years of age or older with a historical diagnosis of type 2 diabetes mellitus - T2DM.
2. The subject meets one of the following criteria:
– The subject has an HbA1c level =7.5 and <10.5%, and has been on a stable daily dose of =1500 mg (or documented maximum tolerated dose [MTD]) of metformin for at least 8 weeks prior to Screening. This subject will immediately enter the Placebo Run-in Period according to Study Schedule A, or;
– The subject has an HbA1c level =7.5 and <10.5%, and has been on a stable daily dose of <1500 mg of metformin without documented MTD for at least 8 weeks prior to Screening. After completing the Screening Visit, this subject will have their metformin dose immediately increased to =1500 mg (or MTD) for an 8-week Titration Period according to Study Schedule B. Following this 8-week period, the subject must qualify for entry into the Placebo Run-in Period by completing the Week -3 procedures including having an HbA1c level =7.5 and <10.5%.
3. The subject has had no treatment with antidiabetic agents other than metformin within 2 months prior to Screening (Exception: if a subject has received other antidiabetic therapy for =7 days within the 2 months prior to Screening).
4. The subject has a body mass index (BMI) =45 kg/m² at Screening.
5. Subjects regularly using other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the counter medications is allowed at the discretion of the investigator.
6. 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.
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 432
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 646

Exclusion Criteria

1. The subject donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
2. Hemoglobin =12 g/dL (=120 g/L) for males and =10 g/dL (=100 g/L) for females at Screening Visit.
3. The subject has systolic blood pressure =160 mm Hg or diastolic pressure =95 mm Hg at Screening Visit. (If the subject meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement.)
4. The subject has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
5. The subject has had treatment for gastric banding or gastric bypass surgery within one year prior to Screening.
6. 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 to or at Screening.
7. The subject has a history of pancreatitis.

Study & Design

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