Trial Outcomes & Findings for Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient (NCT NCT02182895)

NCT ID: NCT02182895

Last Updated: 2017-06-23

Results Overview

mean of average daily blood blood glucose for each patient day

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: Hospital days 2-5
• Results posted on: 2017-06-23

Participant Flow

Participant milestones

Measure	Saxagliptin Group saxagliptin 2.5-5 mg daily	Standard Therapy Group No saxagliptin treatment
Overall Study STARTED	35	37
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Saxagliptin Group saxagliptin 2.5-5 mg daily	Standard Therapy Group No saxagliptin treatment
Overall Study Discharged from hospital within 24 hours	2	4

Baseline Characteristics

Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient

Baseline characteristics by cohort

Measure	Saxagliptin Group n=33 Participants DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime. Saxagliptin: 2.5-5 mg daily	Standard Therapy Group n=33 Participants Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	21 Participants n=7 Participants	47 Participants n=5 Participants
Age, Continuous	69 years STANDARD_DEVIATION 10 • n=5 Participants	67 years STANDARD_DEVIATION 10 • n=7 Participants	68 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized white	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants
BMI	34.5 kg/m^2 STANDARD_DEVIATION 12.2 • n=5 Participants	32.6 kg/m^2 STANDARD_DEVIATION 6.5 • n=7 Participants	33.6 kg/m^2 STANDARD_DEVIATION 10 • n=5 Participants

PRIMARY outcome

Timeframe: Hospital days 2-5

Population: Inpatients with diabetes

mean of average daily blood blood glucose for each patient day

Outcome measures

Measure	Saxagliptin Group n=33 Participants saxagliptin 2.5-5 mg daily	Standard Therapy Group n=33 Participants No saxagliptin treatment
Mean Daily Blood Glucose Levels During Hospital	154.8 mg/dL Standard Deviation 28.2	156.0 mg/dL Standard Deviation 32.1

SECONDARY outcome

Timeframe: Days 2 to 5

Population: completed subjects

Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.

Outcome measures

Measure	Saxagliptin Group n=33 Participants saxagliptin 2.5-5 mg daily	Standard Therapy Group n=33 Participants No saxagliptin treatment
Percentage of Blood Glucose Readings in 70-140 mg/dL Range	42 % of blood glucose readings	37 % of blood glucose readings

SECONDARY outcome

Timeframe: Days 2 to 5

Population: completed subjects

Average daily amount of insulin used

Outcome measures

Measure	Saxagliptin Group n=33 Participants saxagliptin 2.5-5 mg daily	Standard Therapy Group n=33 Participants No saxagliptin treatment
Dose of Insulin	2.4 Units Standard Deviation 3.3	13.3 Units Standard Deviation 12.9

SECONDARY outcome

Timeframe: Days 2 to 5

Population: completed

Number of BG readings <70 mg/dL in each group

Outcome measures

Measure	Saxagliptin Group n=33 Participants saxagliptin 2.5-5 mg daily	Standard Therapy Group n=33 Participants No saxagliptin treatment
Incidence of Hypoglycemia (BG <70 mg/dL)	1 number of events	1 number of events

SECONDARY outcome

Timeframe: Days 2 to 5

Population: completed

Proportion of BG readings in the severe hyperglycemic range.

Outcome measures

Measure	Saxagliptin Group n=33 Participants saxagliptin 2.5-5 mg daily	Standard Therapy Group n=33 Participants No saxagliptin treatment
Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)	6 % of blood glucose readings >200	10 % of blood glucose readings >200

SECONDARY outcome

Timeframe: Days 2 to 5

Population: Patients who allowed a CGMS.

Mean amplitude of glycemic excursions

Outcome measures

Measure	Saxagliptin Group n=20 Participants saxagliptin 2.5-5 mg daily	Standard Therapy Group n=16 Participants No saxagliptin treatment
Variability in Glucose Levels	2.72 mmol/L Standard Deviation 1.60	3.93 mmol/L Standard Deviation 2.03

SECONDARY outcome

Timeframe: Admission to discharge, an expected average of 5 days

Population: completed

Number of days in hospital

Outcome measures

Measure	Saxagliptin Group n=33 Participants saxagliptin 2.5-5 mg daily	Standard Therapy Group n=33 Participants No saxagliptin treatment
Length of Hospital Stay	8.0 days Standard Deviation 14.6	6.4 days Standard Deviation 5.4

SECONDARY outcome

Timeframe: At the time of discharge or Day 5

Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction.

Outcome measures

Measure	Saxagliptin Group n=33 Participants saxagliptin 2.5-5 mg daily	Standard Therapy Group n=33 Participants No saxagliptin treatment
Patient Satisfaction	70 Score Standard Deviation 12	75 Score Standard Deviation 11

Adverse Events

Saxagliptin Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard Therapy Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Saxagliptin Group n=33 participants at risk saxagliptin 2.5-5 mg daily	Standard Therapy Group n=33 participants at risk No saxagliptin treatment
Endocrine disorders Failure to control hyperglucycemia	6.1% 2/33 • Number of events 2 • During the study period.	0.00% 0/33 • During the study period.

Additional Information

Dr. Rajesh Garg, MD

Brigham and Women's Hospital

Phone: 617-732-5584

Email: rgarg@partners.org

Results disclosure agreements

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