Trial Outcomes & Findings for A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178) (NCT NCT01034111)

Results Overview

Safety \& tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Sitagliptin Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin n=30 Participants Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
Age, Customized <= 40 years	5 Participants n=5 Participants
Age, Customized 41 to 50 years	8 Participants n=5 Participants
Age, Customized 51 to 60 years	7 Participants n=5 Participants
Age, Customized >= 60 years	10 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Baseline Fasting Plasma Glucose	8.9 mmol/L STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Safety \& tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.

Outcome measures

Outcome measures
Measure	Sitagliptin n=30 Participants Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment At least one adverse event	5 Participants
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment At least one drug-related adverse event	5 Participants
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment At least one serious adverse event	0 Participants
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment Discontinued treatment due to an adverse event	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 4

Calculated as the mean change from baseline in fasting plasma glucose at Week 4.

Outcome measures

Outcome measures
Measure	Sitagliptin n=30 Participants Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
Change From Baseline in Fasting Plasma Glucose at Week 4	1.6 mmol/L Standard Deviation 2.2

Adverse Events

Sitagliptin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sitagliptin n=30 participants at risk Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
Investigations Hepatic Enzyme Increased	6.7% 2/30 • Number of events 2
Metabolism and nutrition disorders Decreased Appetite	6.7% 2/30 • Number of events 2

Additional Information

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor shall have the opportunity to review all abstracts, drafts or proposed presentations regarding this study 60 days prior to submission for publication/presentation. Any information that the sponsor identifies as confidential should be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER