Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01549964




Registration number
NCT01549964
Ethics application status
Date submitted
6/03/2012
Date registered
9/03/2012
Date last updated
2/06/2016

Titles & IDs
Public title
Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Placebo and Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
2011-001752-10
Secondary ID [2] 0 0
TAK-875_302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycemic Control 0 0
Condition category
Condition code

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

Experimental: Fasiglifam (TAK-875) 25 mg - Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin =1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.

Experimental: Fasiglifam (TAK-875) 50 mg - Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin =1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.

Active comparator: Sitagliptin 100 mg - Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. TAK-875 placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin =1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.

Placebo comparator: Placebo - Fasiglifam (TAK-875) placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin =1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.


Treatment: Drugs: Fasiglifam (TAK-875)
Fasiglifam (TAK-875) tablets

Treatment: Drugs: Sitagliptin
Sitagliptin tablets

Treatment: Drugs: Placebo
Placebo-matching tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Incidence of HbA1c <7%
Timepoint [1] 0 0
24 Weeks
Secondary outcome [2] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG)
Timepoint [2] 0 0
Baseline and Week 24

Eligibility
Key inclusion criteria
1. The participant is male or female and 18 years of age or older with a historical diagnosis of type II diabetes mellitus.
2. The participant meets one of the following criteria:

1. The participant 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 2 months prior to Screening. This participant will immediately enter the Placebo Run-in Period according to Study Schedule A, 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 according to Study Schedule B. Following this 8-week period, the participant 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 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).
4. The participant has a body mass index (BMI) =45 kg/m² at Screening.
5. 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.
6. 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 subject diaries.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The participant 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 participant has systolic blood pressure =160 mm Hg or diastolic pressure =95 mm Hg at Screening Visit. (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement.)
4. The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
5. The participant has had treatment for gastric banding or gastric bypass surgery within one year prior to Screening.
6. The participant 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.

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
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
916
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Maroubra
Recruitment hospital [3] 0 0
- Redcliffe
Recruitment hospital [4] 0 0
- Adelaide
Recruitment hospital [5] 0 0
- Daw Park
Recruitment hospital [6] 0 0
- Box Hill
Recruitment hospital [7] 0 0
- Fitzroy
Recruitment hospital [8] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Maroubra
Recruitment postcode(s) [3] 0 0
- Redcliffe
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Daw Park
Recruitment postcode(s) [6] 0 0
- Box Hill
Recruitment postcode(s) [7] 0 0
- Fitzroy
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Byala
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Kazanlak
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Plovdiv
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Croatia
State/province [29] 0 0
Cakovec
Country [30] 0 0
Croatia
State/province [30] 0 0
Karlovac
Country [31] 0 0
Croatia
State/province [31] 0 0
Krapinske Toplice
Country [32] 0 0
Croatia
State/province [32] 0 0
Rijeka
Country [33] 0 0
Croatia
State/province [33] 0 0
Slavonski Brod
Country [34] 0 0
Croatia
State/province [34] 0 0
Split
Country [35] 0 0
Croatia
State/province [35] 0 0
Zadar
Country [36] 0 0
Croatia
State/province [36] 0 0
Zagreb
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Beroun
Country [38] 0 0
Czech Republic
State/province [38] 0 0
Brno
Country [39] 0 0
Czech Republic
State/province [39] 0 0
Havlickuv Brod
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Kladno
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Kromeriz
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Mlada Boleslav
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Ostrava - Moravska Ostrava
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Ostrava
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Pardubice
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Pisek
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Plzen
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Praha 11
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Praha 2
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Praha 5
Country [51] 0 0
Czech Republic
State/province [51] 0 0
Praha 6
Country [52] 0 0
Czech Republic
State/province [52] 0 0
Praha 8
Country [53] 0 0
Czech Republic
State/province [53] 0 0
Usti nad Labem
Country [54] 0 0
Hungary
State/province [54] 0 0
Baja
Country [55] 0 0
Hungary
State/province [55] 0 0
Balatonfured
Country [56] 0 0
Hungary
State/province [56] 0 0
Budaors
Country [57] 0 0
Hungary
State/province [57] 0 0
Budapest
Country [58] 0 0
Hungary
State/province [58] 0 0
Debrecen
Country [59] 0 0
Hungary
State/province [59] 0 0
Eger
Country [60] 0 0
Hungary
State/province [60] 0 0
Godollo
Country [61] 0 0
Hungary
State/province [61] 0 0
Gyongyos
Country [62] 0 0
Hungary
State/province [62] 0 0
Gyula
Country [63] 0 0
Hungary
State/province [63] 0 0
Hodmezovasarhely
Country [64] 0 0
Hungary
State/province [64] 0 0
Kecskemet
Country [65] 0 0
Hungary
State/province [65] 0 0
Kistelek
Country [66] 0 0
Hungary
State/province [66] 0 0
Kisvarda
Country [67] 0 0
Hungary
State/province [67] 0 0
Komarom
Country [68] 0 0
Hungary
State/province [68] 0 0
Mohacs
Country [69] 0 0
Hungary
State/province [69] 0 0
Nyiregyhaza
Country [70] 0 0
Hungary
State/province [70] 0 0
Pecs
Country [71] 0 0
Hungary
State/province [71] 0 0
Szeged
Country [72] 0 0
Hungary
State/province [72] 0 0
Szekszard
Country [73] 0 0
Hungary
State/province [73] 0 0
Szikszo
Country [74] 0 0
Hungary
State/province [74] 0 0
Szolnok
Country [75] 0 0
Hungary
State/province [75] 0 0
Szombathely
Country [76] 0 0
Hungary
State/province [76] 0 0
Urhida
Country [77] 0 0
Hungary
State/province [77] 0 0
Veszprem
Country [78] 0 0
Hungary
State/province [78] 0 0
Zalaegerszeg
Country [79] 0 0
Italy
State/province [79] 0 0
Milano
Country [80] 0 0
Italy
State/province [80] 0 0
Firenze
Country [81] 0 0
Italy
State/province [81] 0 0
Pavia
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Gyeonggi-do
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Incheon
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Seoul
Country [85] 0 0
Malaysia
State/province [85] 0 0
Johor
Country [86] 0 0
Malaysia
State/province [86] 0 0
Kedah
Country [87] 0 0
Malaysia
State/province [87] 0 0
Kelantan
Country [88] 0 0
Malaysia
State/province [88] 0 0
Kuala Lumpur
Country [89] 0 0
Malaysia
State/province [89] 0 0
Selangor
Country [90] 0 0
Slovakia
State/province [90] 0 0
Banska Bystrica
Country [91] 0 0
Slovakia
State/province [91] 0 0
Bardejov
Country [92] 0 0
Slovakia
State/province [92] 0 0
Bratislava
Country [93] 0 0
Slovakia
State/province [93] 0 0
Kosice - Saca
Country [94] 0 0
Slovakia
State/province [94] 0 0
Kosice
Country [95] 0 0
Slovakia
State/province [95] 0 0
Levice
Country [96] 0 0
Slovakia
State/province [96] 0 0
Lucenec
Country [97] 0 0
Slovakia
State/province [97] 0 0
Moldava nad Bodvou
Country [98] 0 0
Slovakia
State/province [98] 0 0
Nitra
Country [99] 0 0
Slovakia
State/province [99] 0 0
Pezinok
Country [100] 0 0
Slovakia
State/province [100] 0 0
Presov
Country [101] 0 0
Slovakia
State/province [101] 0 0
Prievidza
Country [102] 0 0
Slovakia
State/province [102] 0 0
Sahy
Country [103] 0 0
Slovakia
State/province [103] 0 0
Stropkov
Country [104] 0 0
Slovakia
State/province [104] 0 0
Sturovo
Country [105] 0 0
Slovakia
State/province [105] 0 0
Svidnik
Country [106] 0 0
Slovakia
State/province [106] 0 0
Trebisov
Country [107] 0 0
Slovakia
State/province [107] 0 0
Trencin
Country [108] 0 0
Slovakia
State/province [108] 0 0
Zilina
Country [109] 0 0
Thailand
State/province [109] 0 0
Bangkok
Country [110] 0 0
Thailand
State/province [110] 0 0
Chiang Mai
Country [111] 0 0
Thailand
State/province [111] 0 0
Nakhon Ratchasima
Country [112] 0 0
Thailand
State/province [112] 0 0
Songkhla
Country [113] 0 0
Thailand
State/province [113] 0 0
Khon Kaen

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Senior Medical Director Clinical Science
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01549964