Trial Outcomes & Findings for Fasiglifam 25 mg BID vs 50 mg QD (NCT NCT01982253)

NCT ID: NCT01982253

Last Updated: 2016-10-07

Results Overview

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2016-10-07

Participant Flow

Participants took part in the study at 5 investigative sites in the United States from 21 October 2013 to 31 January 2014.

Participants with a historical diagnosis of type 2 diabetes mellitus and inadequate glycemic control on diet and exercise alone were enrolled in 1 of 3 treatment groups, placebo, fasiglifam 25 milligram (mg) twice daily (BID) and fasiglifam 50 mg once daily (QD).

Participant milestones

Participant milestones
Measure	Placebo Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.	Fasiglifam 25 mg BID Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.	Fasiglifam 50 mg QD Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
Overall Study STARTED	2	4	4
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	2	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.	Fasiglifam 25 mg BID Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.	Fasiglifam 50 mg QD Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
Overall Study Withdrawal by Subject	1	0	0
Overall Study Study terminated by sponsor	1	4	4

Baseline Characteristics

Fasiglifam 25 mg BID vs 50 mg QD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=2 Participants Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.	Fasiglifam 25 mg BID n=4 Participants Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.	Fasiglifam 50 mg QD n=4 Participants Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.	Total n=10 Participants Total of all reporting groups
Age, Customized 18 to 64 years	1 participants n=99 Participants	4 participants n=107 Participants	4 participants n=206 Participants	9 participants n=7 Participants
Age, Customized 65 to 84 years	1 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	1 participants n=7 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	6 Participants n=7 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	4 Participants n=7 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants	2 participants n=7 Participants
Race/Ethnicity, Customized White	1 participants n=99 Participants	4 participants n=107 Participants	3 participants n=206 Participants	8 participants n=7 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 participants n=99 Participants	3 participants n=107 Participants	1 participants n=206 Participants	5 participants n=7 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	1 participants n=99 Participants	1 participants n=107 Participants	3 participants n=206 Participants	5 participants n=7 Participants
Glycosylated Haemoglobin (HbA1c) Less than (<) 8.5 percent (%)	2 participants n=99 Participants	2 participants n=107 Participants	3 participants n=206 Participants	7 participants n=7 Participants
Glycosylated Haemoglobin (HbA1c) Greater than or equal to (≥) 8.5 percent (%)	0 participants n=99 Participants	2 participants n=107 Participants	1 participants n=206 Participants	3 participants n=7 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 12

The change between the FPG value collected at week 12 or final visit relative to baseline.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Fasiglifam 25 mg BID

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Fasiglifam 50 mg QD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=2 participants at risk Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.	Fasiglifam 25 mg BID n=4 participants at risk Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.	Fasiglifam 50 mg QD n=4 participants at risk Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
Gastrointestinal disorders Abdominal distension	50.0% 1/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	0.00% 0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	0.00% 0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.
Gastrointestinal disorders Abdominal hernia	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	0.00% 0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	25.0% 1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.
Infections and infestations Bronchitis	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	25.0% 1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	0.00% 0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.
Gastrointestinal disorders Constipation	50.0% 1/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	0.00% 0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	0.00% 0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.
Nervous system disorders Hypoaesthesia	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	0.00% 0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	25.0% 1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.
Infections and infestations Nasopharyngitis	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	0.00% 0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	25.0% 1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	0.00% 0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.	25.0% 1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and within 30 days after the last dose of double-blind study drug. 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.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER