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TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01829464
Recruitment Status : Terminated (Due to potential concerns about liver safety (See Detailed Description))
First Posted : April 11, 2013
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes
Interventions Drug: Placebo
Drug: TAK-875
Enrollment 90
Recruitment Details Participants took part in the study at 49 investigative sites in the United States from 01 April 2013 to 12 March 2014.
Pre-assignment Details Participants with historical diagnosis of type 2 diabetes who were inadequately controlled while on sitagliptin 100 milligram(mg) (with/without metformin) or on Dipeptidyl peptidase-4 inhibitor other than sitagliptin(with/without metformin) therapy enrolled in 1 of 3, placebo; fasiglifam 25 mg once daily (QD); fasiglifam 50 mg QD treatment groups.
Arm/Group Title Placebo Fasiglifam 25 mg QD Fasiglifam 50 mg QD
Hide Arm/Group Description Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks. Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks. Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Period Title: Overall Study
Started 30 31 29
Completed 2 2 3
Not Completed 28 29 26
Reason Not Completed
Adverse Event             1             0             0
Lost to Follow-up             0             0             1
Withdrawal by Subject             2             0             0
Study terminated by sponsor             25             28             25
Lack of Efficacy             0             1             0
Arm/Group Title Placebo Fasiglifam 25 mg QD Fasiglifam 50 mg QD Total
Hide Arm/Group Description Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks. Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks. Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 30 31 29 90
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomized participants who received at least 1 dose of double blind study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 31 participants 29 participants 90 participants
57.0  (10.45) 52.4  (11.61) 55.2  (8.57) 54.8  (10.38)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 29 participants 90 participants
Less than (<) 65 years 22 27 24 73
>= 65 years 8 4 5 17
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 29 participants 90 participants
Female 14 13 16 43
Male 16 18 13 47
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 29 participants 90 participants
Hispanic or Latino 6 11 5 22
Not Hispanic or Latino 24 20 24 68
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 29 participants 90 participants
Asian 1 3 1 5
Black or African American 3 1 2 6
Native Hawaiian or Other Pacific Islander 1 0 0 1
White 25 26 26 77
More than 1 race (multiracial) 0 1 0 1
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 30 participants 31 participants 29 participants 90 participants
168.3  (9.26) 169.0  (10.02) 166.8  (10.76) 168.0  (9.96)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 30 participants 31 participants 29 participants 90 participants
34.49  (5.623) 32.12  (5.664) 33.10  (4.315) 33.23  (5.286)
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 29 participants 90 participants
30 31 29 90
[1]
Measure Description: Enrollment in the United States is reported.
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 29 participants 90 participants
Never smoked 18 19 22 59
Current smoker 7 5 1 13
Ex-smoker 5 7 6 18
Baseline Glycosylated Hemoglobin (HbA1c) Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 29 participants 90 participants
< 8.5 percent (%) 16 16 15 47
>= 8.5% 14 15 14 43
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 31 participants 29 participants 90 participants
9.291  (8.039) 8.690  (6.180) 6.406  (4.390) 8.154  (6.444)
1.Primary Outcome
Title Change From Baseline in HbA1c at Week 24
Hide Description 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) collected at Week 24 relative to baseline.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.
Arm/Group Title Placebo Fasiglifam 25 mg QD Fasiglifam 50 mg QD
Hide Arm/Group Description:
Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Overall Number of Participants Analyzed 26 31 27
Mean (Standard Deviation)
Unit of Measure: Percentage of glycosylated haemoglobin
Baseline (n= 26, 31, 27) 8.39  (0.766) 8.46  (0.932) 8.52  (0.956)
Change at Week 24 (n= 2, 4, 2) 0.25  (0.495) -0.80  (0.883) -1.85  (0.495)
2.Secondary Outcome
Title Percentage of Participants With HbA1c <7%
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the relatively limited enrollment and follow-up at the time of study termination, the analysis of percentage of participants with HbA1c <7% at Week 24 was not performed.
Arm/Group Title Placebo Fasiglifam 25 mg QD Fasiglifam 50 mg QD
Hide Arm/Group Description:
Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description The change between the fasting plasma glucose values collected at Week 24 relative to baseline.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.
Arm/Group Title Placebo Fasiglifam 25 mg QD Fasiglifam 50 mg QD
Hide Arm/Group Description:
Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
Overall Number of Participants Analyzed 29 31 28
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline (n= 29, 31, 28) 193.76  (50.090) 184.52  (45.126) 185.96  (53.767)
Change at Week 24 (n= 2, 2, 2) 30.50  (55.861) -31.50  (16.263) -85.50  (23.335)
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug.
Adverse Event Reporting Description At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Placebo Fasiglifam 25 mg QD Fasiglifam 50 mg QD
Hide Arm/Group Description Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks. Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks. Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
All-Cause Mortality
Placebo Fasiglifam 25 mg QD Fasiglifam 50 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Fasiglifam 25 mg QD Fasiglifam 50 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   1/31 (3.23%)   0/29 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst  1  0/30 (0.00%)  1/31 (3.23%)  0/29 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Fasiglifam 25 mg QD Fasiglifam 50 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/30 (26.67%)   10/31 (32.26%)   15/29 (51.72%) 
Gastrointestinal disorders       
Dyspepsia  1  0/30 (0.00%)  2/31 (6.45%)  0/29 (0.00%) 
Diarrhoea  1  1/30 (3.33%)  2/31 (6.45%)  2/29 (6.90%) 
General disorders       
Influenza like illness  1  0/30 (0.00%)  0/31 (0.00%)  2/29 (6.90%) 
Pain  1  0/30 (0.00%)  1/31 (3.23%)  2/29 (6.90%) 
Infections and infestations       
Sinusitis  1  1/30 (3.33%)  0/31 (0.00%)  2/29 (6.90%) 
Nasopharyngitis  1  1/30 (3.33%)  1/31 (3.23%)  3/29 (10.34%) 
Upper respiratory tract infection  1  0/30 (0.00%)  3/31 (9.68%)  3/29 (10.34%) 
Investigations       
Amylase increased  1  2/30 (6.67%)  1/31 (3.23%)  2/29 (6.90%) 
Lipase increased  1  2/30 (6.67%)  2/31 (6.45%)  2/29 (6.90%) 
Metabolism and nutrition disorders       
Hyperglycaemia  1  0/30 (0.00%)  0/31 (0.00%)  2/29 (6.90%) 
Nervous system disorders       
Headache  1  0/30 (0.00%)  2/31 (6.45%)  2/29 (6.90%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  3/30 (10.00%)  2/31 (6.45%)  0/29 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01829464    
Other Study ID Numbers: TAK-875_303
U1111-1124-2270 ( Registry Identifier: UTN (WHO) )
First Submitted: April 9, 2013
First Posted: April 11, 2013
Results First Submitted: July 24, 2015
Results First Posted: June 1, 2016
Last Update Posted: June 1, 2016