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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01481116




Registration number
NCT01481116
Ethics application status
Date submitted
25/11/2011
Date registered
29/11/2011
Date last updated
1/06/2016

Titles & IDs
Public title
Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes
Scientific title
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
Secondary ID [1] 0 0
2011-001731-24
Secondary ID [2] 0 0
TAK-875_304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAK-875
Treatment: Drugs - TAK-875
Treatment: Drugs - Glimepiride

Experimental: TAK-875 25 mg QD -

Experimental: TAK-875 50 mg QD -

Active comparator: Glimepiride 1-2 mg QD -


Treatment: Drugs: TAK-875
TAK-875 25 mg, tablets, orally, once daily and metformin =1500 mg or Maximum Tolerated Dose (MTD) for up to 104 weeks.

Treatment: Drugs: TAK-875
TAK-875 50 mg, tablets, orally, once daily and metformin =1500 mg or MTD for up to 104 weeks.

Treatment: Drugs: Glimepiride
Glimepiride 1 mg, tablets, orally, once daily (up-titrated to 2 mg after 1 week of treatment. Up-titrated to a maximum of 6 mg in 2 mg increments/down titrated if recurrent (or severe) hypoglycemia occurs) and metformin =1500 mg or MTD for up to 104 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in HbA1c at Weeks 78 and 104
Timepoint [1] 0 0
Baseline and Weeks 78 and 104
Secondary outcome [1] 0 0
Percentage of Participants With Hypoglycemia
Timepoint [1] 0 0
Day 1 up to Weeks 78 and 104
Secondary outcome [2] 0 0
Change From Baseline in Body Weight at Weeks 78 and 104
Timepoint [2] 0 0
Baseline and Weeks 78 and 104
Secondary outcome [3] 0 0
Change From Baseline in HbA1c at Weeks 26 and 52
Timepoint [3] 0 0
Baseline and Weeks 26 and 52
Secondary outcome [4] 0 0
Percentage of Participants With HbA1c <7%
Timepoint [4] 0 0
Weeks 26, 52, 78 and 104
Secondary outcome [5] 0 0
Percentage of Participants With HbA1c <7% for Participants Who Did Not Report Hypoglycemia
Timepoint [5] 0 0
Weeks 26, 52, 78 and 104
Secondary outcome [6] 0 0
Change From Baseline in Fasting Plasma Glucose at Weeks 26, 52, 78 and 104
Timepoint [6] 0 0
Baseline and Weeks 26, 52, 78 and 104

Eligibility
Key inclusion criteria
1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
2. The participant or, when applicable, the participant'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 participant is male or female and 18 years of age or older with a historical diagnosis of T2DM.
4. The participant meets one of the following criteria:

1. The participant has an HbA1c level =7.0 and <10.0%, and has been on a stable daily dose of =1500 mg (or documented MTD) of metformin for at least 2 months prior to Screening. This participant will immediately enter the Placebo Run-in Period, or;
2. The participant 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 participant will have their metformin dose immediately increased to =1500 mg (or MTD) for an 8-week Titration Period. Following this 8-week period, the participant must qualify for entry into the Placebo Run-in Period by completing the Week -3 procedures and having an HbA1c concentration =7.0 and <10.0%.
5. The participant has had no treatment with antidiabetic agents other than metformin within 2 months prior to Screening (Exception: if a participant has received other antidiabetic therapy for =7 days within the 2 months prior to Screening).
6. The participant has a body mass index (BMI) of =45 kg/m2 at Screening.
7. Participants 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.
8. The participant is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete participant diaries.

Additional Inclusion Criteria Prior to Randomization

1. The participant has an HbA1c concentration =7.0% and <10.0%, and a FPG =270 mg/dL (15.0 mmol/L) at the Week -1 Visit. (If the subject does not qualify for randomization based on these criteria, the assessment may be repeated weekly, for a maximum of 2 additional weeks).
2. The participant's compliance with the single-blind study medication during the Placebo Run-in Period is at least 75% and does not exceed 125% based on tablet/capsule counts performed by the study staff.
3. A female participant of childbearing potential must have a negative urine hCG pregnancy test at Baseline (Day 1) prior to Randomization and prior to administration of the first dose of double-blind study medication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The participant has 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 participant has been randomized into a previous TAK-875 study
3. The participant 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 (e.g., spouse, parent, child, sibling) or may consent under duress.
4. The participant donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
5. The participant has a hemoglobin =12 g/dL (=120 gm/L) for males and =10 g/dL (=100 gm/L) for females at Screening.
6. The participant has a systolic blood pressure =160 mm Hg or diastolic pressure =95 mm Hg at Screening (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement).
7. The participant has 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 participant has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x upper limit of normal (ULN) at Screening.
9. The participant has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome the participant will be allowed with an elevated bilirubin level per the investigator's discretion.
10. The participant has a serum creatinine =1.5 mg/dL(males) and =1.4 mg/dL(females) and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at Screening.
11. The participant has uncontrolled thyroid disease.
12. The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
13. The participant has had gastric banding, or gastric bypass surgery within one year prior to Screening.
14. The participant has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
15. The participant 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 participant has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875, metformin, or glimepiride.
17. The participant 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 participant received excluded medications prior to Screening or is expected to receive excluded medication.
19. If female, the participant is pregnant (confirmed by laboratory testing, i.e., 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 participant is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
21. The participant has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the participant according to the protocol.

Additional Exclusion Criteria Prior to Randomization

1. The participant has received excluded medications listed in the protocol during the Placebo Run-in Period (topical and inhaled corticosteroids are allowed).
2. The participant has a systolic blood pressure =160 mm Hg or diastolic blood pressure =95 mm Hg at Baseline (Day 1) (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).
3. The participant 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 (GFR) <60 mL/min/1.73m2 at Visit 3 (Schedule B subjects only).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
Accrual to date
Final
2454
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 0 0
- Canberra
Recruitment hospital [2] 0 0
- Brookvale
Recruitment hospital [3] 0 0
- Mosman
Recruitment hospital [4] 0 0
- Woy Woy
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Brookvale
Recruitment postcode(s) [3] 0 0
- Mosman
Recruitment postcode(s) [4] 0 0
- Woy Woy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Florida
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Georgia
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Indiana
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Kansas
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Maryland
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Michigan
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Mississippi
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Nebraska
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North Carolina
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Ohio
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Oklahoma
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South Carolina
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Texas
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Utah
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Virginia
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Santa Fe
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Cordoba
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United Kingdom
State/province [175] 0 0
East Riding of Yorkshire
Country [176] 0 0
United Kingdom
State/province [176] 0 0
East Sussex
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Hertfordshire
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Lancashire
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Merseyside
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Middlesex
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Somerset
Country [182] 0 0
United Kingdom
State/province [182] 0 0
South Glamorgan
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Cardiff

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).
Trial website
https://clinicaltrials.gov/study/NCT01481116
Trial related presentations / publications
Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.
Public notes

Contacts
Principal investigator
Name 0 0
Senior Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01481116