Trial Outcomes & Findings for Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus (NCT NCT01826370)

Results Overview

Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.

Recruitment status

TERMINATED

Target enrollment

678 participants

Primary outcome timeframe

Week 24

Results posted on

2014-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Linagliptin Linagliptin 5 mg was administered orally once a day for 24 weeks
Overall Study STARTED	678
Overall Study COMPLETED	658
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Linagliptin Linagliptin 5 mg was administered orally once a day for 24 weeks
Overall Study Protocol Violation	6
Overall Study Lost to Follow-up	12
Overall Study Other reason not defined above	2

Baseline Characteristics

Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Linagliptin n=660 Participants Linagliptin 5 mg was administered orally once a day for 24 weeks
Age, Continuous	57.67 years STANDARD_DEVIATION 13.3 • n=5 Participants
Gender Female	360 participants n=5 Participants
Gender Male	296 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.

Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.

Outcome measures

Outcome measures
Measure	Linagliptin n=660 Participants Linagliptin 5 mg was administered orally once a day for 24 weeks
Frequency of Adverse Events and Serious Adverse Events Adverse Events	0.8 percentage of participants
Frequency of Adverse Events and Serious Adverse Events Serious Adverse Events	0.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for HbA1c.

Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)

Outcome measures

Outcome measures
Measure	Linagliptin n=625 Participants Linagliptin 5 mg was administered orally once a day for 24 weeks
Change From Baseline to Week 24 of HbA1c	-1.7 percentage of HbA1c Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for fasting blood sugar.

Change from baseline to week 24 of fasting blood sugar

Outcome measures

Outcome measures
Measure	Linagliptin n=629 Participants Linagliptin 5 mg was administered orally once a day for 24 weeks
Change From Baseline to Week 24 of Fasting Blood Sugar	-65.0 mg/dl Standard Deviation 66.5

Adverse Events

Linagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER