A Controlled Study to Investigate the Effectiveness and Safety of TAK-875 Compared to Glimepiride When Used in Combination with Metformin in Individuals Diagnosed with Type 2 Diabetes

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001731-24-LV

Enrollment

2610

Registered

2011-12-20

Start date

2012-02-29

Completion date

Unknown

Last updated

2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus (T2DM) MedDRA version: 14.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus System Organ Class: 100

Interventions

Product Code: TAK-875 25mg Pharmaceutical Form: Film-coated tablet Current Sponsor code: TAK-875 Other descriptive name: TAK-875 Concentration unit: mg milligram(s) Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 1512

Exclusion criteria

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 Screening. 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of TAK-875 plus metformin compared to glimepiride plus metformin on glycemic control as assessed by change from baseline in HbA1c at Weeks 78 and 104.;Secondary Objective: To evaluate the effect of TAK-875 plus metformin compared to glimepiride plus metformin on the incidence of hypoglycemic events from Day 1 to Week 78 and from Day 1 to Week 104, change from baseline in body weight at Weeks 78 and 104, and other measures of glycemic control, including change from baseline in HbA1c at Weeks 26 and 52, incidence of HbA1c levels <7%, fasting plasma glucose (FPG) at Weeks 26, 52, 78 and 104.;Primary end point(s): Primary Endpoint: - Change from baseline in HbA1c at Weeks 78 and 104. ;Timepoint(s) of evaluation of this end point: Weeks 78 and 104 of treatment.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of TAK-875 plus metformin compared to glimepiride plus metformin on glycemic control as assessed by change from baseline in HbA1c at Weeks 78 and 104.;Secondary Objective: To evaluate the effect of TAK-875 plus metformin compared to glimepiride plus metformin on the incidence of hypoglycemic events from Day 1 to Week 78 and from Day 1 to Week 104, change from baseline in body weight at Weeks 78 and 104, and other measures of glycemic control, including change from baseline in HbA1c at Weeks 26 and 52, incidence of HbA1c levels <7%, fasting plasma glucose (FPG) at Weeks 26, 52, 78 and 104.;Primary end point(s): Primary Endpoint: - Change from baseline in HbA1c at Weeks 78 and 104. ;Timepoint(s) of evaluation of this end point: Weeks 78 and 104 of treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary endpoints for this study are: 1. Incidence of hypoglycemia, from Day 1 to Week 78 and from Day 1 to Week 104. 2. Change from baseline in body weight at Weeks 78 and 104. Other secondary endpoints for this study are: 1. Change from baseline in HbA1c at Weeks 26 and 52. 2. Incidence of HbA1c <7% at Weeks 26, 52, 78 and 104 for all subjects (regardless of whether subjects reported hypoglycemia). 3. Incidence of HbA1c <7% at Weeks 26, 52, 78, and 104 for subjects who do not report hypoglycemia. 4. Change from baseline in FPG at Weeks 26, 52, 78 and 104.;Timepoint(s) of evaluation of this end point: Weeks 78 and 104 of treatment for key secondary endpoint. Weeks 26, 52, 78 and 104 of treatment for all other secondary endpoints.	—

Measure

Time frame

Secondary end point(s): Key secondary endpoints for this study are: 1. Incidence of hypoglycemia, from Day 1 to Week 78 and from Day 1 to Week 104. 2. Change from baseline in body weight at Weeks 78 and 104. Other secondary endpoints for this study are: 1. Change from baseline in HbA1c at Weeks 26 and 52. 2. Incidence of HbA1c <7% at Weeks 26, 52, 78 and 104 for all subjects (regardless of whether subjects reported hypoglycemia). 3. Incidence of HbA1c <7% at Weeks 26, 52, 78, and 104 for subjects who do not report hypoglycemia. 4. Change from baseline in FPG at Weeks 26, 52, 78 and 104.;Timepoint(s) of evaluation of this end point: Weeks 78 and 104 of treatment for key secondary endpoint. Weeks 26, 52, 78 and 104 of treatment for all other secondary endpoints.

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Countries

Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Estonia, Germany, Hong Kong, Israel, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Philippines, Poland, Romania, Russian Federation, South Africa, Taiwan, Ukraine, United Kingdom, United States

Contacts

Public ContactProgram Manager

Takeda Global Research & Development Centre (Europe) Ltd.

clinicaloperations@tgrd.com00440203116 8000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026