EUCTR2011-001731-24-CZActive, not recruitingPhase 1
A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Glimepiride When Used in Combination with Metformin in Subjects with Type 2 Diabetes - Comparison of TAK-875 to Glimepiride in Combination with Metformin in Subjects with Type II Diabetes
Takeda Development Centre Europe Ltd.0 sites2,610 target enrollmentStarted: December 23, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 2,610
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 T2DM.
- •2. The subject meets one of the following criteria:
- •– The subject has an HbA1c level =7.0 and <10.0%, and has been on a stable daily dose of =1500 mg (or
- •documented maximum tolerated dose [MTD]) of metformin for at least 2 months 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 2 months 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 =7.0 and <10.0%.
- •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 1008
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1512
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 gm/L) for males and =10 g/dL (=100 gm/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
- •5. The subject has had 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.
Investigators
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