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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline.
Timepoint [1] 0 0
Baseline and Weeks 78 and 104
Secondary outcome [1] 0 0
Percentage of Participants With Hypoglycemia - Participants were provided diaries to document any hypoglycemic events that occurred between study visits. Any experience of hypoglycemic signs and symptoms (regardless of the blood glucose value by glucometer) or had a blood glucose value less than or equal to (<=) 70 milligram per deciliter (mg/dL) (3.9 millimole per liter (mmol/L) by glucometer (regardless of symptoms) were to be recorded.
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 - The change between the body weight to be collected at Weeks 78 and 104 relative to baseline.
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 - The change in the value of HbA1c collected at Weeks 26 and 52 relative to baseline.
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 - The change between the fasting plasma glucose value to be collected at Weeks 26, 52, 78 and 104 relative to baseline.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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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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Utah
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Argentina
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Lodz
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Lublin
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Poznan
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Pulawy
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Ruda Slaska
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Rzeszow
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Sopot
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Torun
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Bacau
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Romania
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Baia Mare
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Romania
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Bucuresti
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Romania
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Constanta
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Iasi
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Romania
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Oradea
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Romania
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Ploiesti
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Romania
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Targu Mures
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Romania
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Timisoara
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Yaroslavl
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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KwaZulu-Natal
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South Africa
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Mpumalanga
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Western Cape
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Taiwan
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Ukraine
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Dnipropetrovsk
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Ivano-Frankivsk
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Kharkiv
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Kiev
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Ukraine
State/province [165] 0 0
Kyiv
Country [166] 0 0
Ukraine
State/province [166] 0 0
Lugansk
Country [167] 0 0
Ukraine
State/province [167] 0 0
Lviv
Country [168] 0 0
Ukraine
State/province [168] 0 0
Mykolayiv
Country [169] 0 0
Ukraine
State/province [169] 0 0
Poltava
Country [170] 0 0
Ukraine
State/province [170] 0 0
Ternopil
Country [171] 0 0
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State/province [171] 0 0
Vinnytsia
Country [172] 0 0
Ukraine
State/province [172] 0 0
Zaporizhzhia
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Cheshire
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Devon
Country [175] 0 0
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
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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/show/NCT01481116
Trial related presentations / publications
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/show/NCT01481116