Trial Outcomes & Findings for Changes in Bone Turnover With Increased Incretin Hormone Exposure (NCT NCT01374568)

NCT ID: NCT01374568

Last Updated: 2017-07-24

Results Overview

Bone turnover assessed using change in TRACP5b over 8 weeks of treatment.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-07-24

Participant Flow

Postmenopausal women with diabetes mellitus on no medications or metformin treatment alone were recruited from an outpatient clinic setting.

Potential participants completed a screening visit to ensure all study inclusion criteria were met. If on metformin at the screening visit, the metformin was discontinued. Potential participants presented 1 month later for the baseline visit and for randomization.

Participant milestones

Participant milestones
Measure	Sitagliptin Sitagliptin sitagliptin: sitagliptin 100mg daily	Placebo Placebo Placebo: 1 pill daily
Overall Study STARTED	2	3
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin Sitagliptin sitagliptin: sitagliptin 100mg daily	Placebo Placebo Placebo: 1 pill daily
Overall Study Lab unable to analyze BTM	0	2

Baseline Characteristics

Changes in Bone Turnover With Increased Incretin Hormone Exposure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin n=2 Participants Sitagliptin sitagliptin: sitagliptin 100mg daily	Placebo n=3 Participants Placebo Placebo: 1 pill daily	Total n=5 Participants Total of all reporting groups
Age, Continuous	57.5 years STANDARD_DEVIATION 6.5 • n=99 Participants	61.0 years STANDARD_DEVIATION 8.3 • n=107 Participants	61.0 years STANDARD_DEVIATION 8.6 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	2 participants n=99 Participants	3 participants n=107 Participants	5 participants n=206 Participants
Systolic Blood Pressure	119 mmHg STANDARD_DEVIATION 11.0 • n=99 Participants	130 mmHg STANDARD_DEVIATION 10.0 • n=107 Participants	130 mmHg STANDARD_DEVIATION 12.4 • n=206 Participants
Diastolic Blood Pressure	82 mmHg STANDARD_DEVIATION 8 • n=99 Participants	78 mmHg STANDARD_DEVIATION 6.2 • n=107 Participants	78 mmHg STANDARD_DEVIATION 7.0 • n=206 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The difference between the bone turnover markers TRACP5b from baseline to end of study were calculated for treatment and placebo groups. Serum samples were not available for one placebo participant at baseline and for one placebo patient at end of study. As a result we were unable to analyze the 2 participants with missing data.

Bone turnover assessed using change in TRACP5b over 8 weeks of treatment.

Outcome measures

Outcome measures
Measure	Sitagliptin n=2 Participants Sitagliptin sitagliptin: sitagliptin 100mg daily	Placebo n=1 Participants Placebo Placebo: 1 pill daily
Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo.	-0.25 U/L Standard Deviation 0.07	0.30 U/L Standard Deviation 0

PRIMARY outcome

Timeframe: 8 WEEKS

Population: The difference between the bone turnover markers bone alkaline phosphatase (BAP) from baseline to end of study were calculated for treatment and placebo groups. Serum samples were not available for one placebo participant at baseline and for one placebo patient at end of study.

Bone turnover assessed using change in bone-specific alkaline phosphatase (BAP) over 8 weeks of treatment.

Outcome measures

Outcome measures
Measure	Sitagliptin n=2 Participants Sitagliptin sitagliptin: sitagliptin 100mg daily	Placebo n=1 Participants Placebo Placebo: 1 pill daily
Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo	0.05 mg/L Standard Deviation 1.34	0 mg/L Standard Deviation 0

Adverse Events

Sitagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Amy Warriner

UAB

Phone: 2059964004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place