Trial Outcomes & Findings for Liraglutide Hospital Discharge Trial (NCT NCT01919489)

NCT ID: NCT01919489

Last Updated: 2021-11-03

Results Overview

To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 273 participants
• Primary outcome timeframe: Hospital discharge, 6 months (26 weeks)
• Results posted on: 2021-11-03

Participant Flow

Participant milestones

Measure	Liraglutide + OADs Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Overall Study STARTED	136	137
Overall Study COMPLETED	80	93
Overall Study NOT COMPLETED	56	44

Reasons for withdrawal

Measure	Liraglutide + OADs Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Overall Study Rejected the need of injections	4	7
Overall Study Adverse Event	10	0
Overall Study Hospital readmission	2	9
Overall Study Death	2	1
Overall Study Lost to Follow-up	38	27

Baseline Characteristics

Liraglutide Hospital Discharge Trial

Baseline characteristics by cohort

Measure	Liraglutide + OADs n=136 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=137 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously	Total n=273 Participants Total of all reporting groups
Age, Continuous	56.1 years STANDARD_DEVIATION 9.5 • n=5 Participants	55.9 years STANDARD_DEVIATION 11.2 • n=7 Participants	56.1 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	61 Participants n=7 Participants	108 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	76 Participants n=7 Participants	165 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	97 Participants n=5 Participants	95 Participants n=7 Participants	192 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	133 participants n=5 Participants	134 participants n=7 Participants	267 participants n=5 Participants
Region of Enrollment Argentina	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Hospital discharge, 6 months (26 weeks)

Population: Number of subjects analyzed at 6 months differs from overall number of subjects analyzed, due to patients unable to complete the trial: 56 in the Liraglutide Arm and 44 in the Glargine Arm.

To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy

Outcome measures

Measure	Liraglutide + OADs n=136 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=137 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Glycemic Control at Hospital Discharge and 6 Months Follow up HbA1C at hospital discharge	8.3 % (mmol/mol) Standard Deviation 0.9	8.4 % (mmol/mol) Standard Deviation 0.8
Glycemic Control at Hospital Discharge and 6 Months Follow up HbA1C at 6 months post-intervention	7.13 % (mmol/mol) Standard Deviation 1.3	7.68 % (mmol/mol) Standard Deviation 1.69

SECONDARY outcome

Timeframe: After discharge, average at 3 months (12 week) and 6 months (26 weeks)

Population: The number of subjects analyzed in this outcome at different time points from the overall number of subjects analyzed in other timepoints because it includes only those participants who were able to provide blood glucose results at the specified time points reported (12 and 26 weeks).

To determine differences in BG concentration between liraglutide and glargine insulin therapy

Outcome measures

Measure	Liraglutide + OADs n=60 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=79 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks Fasting blood glucose at 26 weeks follow up	7.61 mmol/L Standard Deviation 2.2	8.56 mmol/L Standard Deviation 3.8
Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks Post-prandial blood glucose at 12 weeks	7.67 mmol/L Standard Deviation 1.6	9.32 mmol/L Standard Deviation 8.8
Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks Postprandial blood glucose at 26 weeks follow up	8.23 mmol/L Standard Deviation 2.8	8.72 mmol/L Standard Deviation 2.3
Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks Fasting blood glucose at 12 weeks	7.96 mmol/L Standard Deviation 3.3	7.70 mmol/L Standard Deviation 2.6

SECONDARY outcome

Timeframe: After discharge, average 6 months

Number of participants who had at least one hypoglycemic event (<70 mg/dl) and severe hypoglycemic event (<40 mg/dl)

Outcome measures

Measure	Liraglutide + OADs n=136 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=137 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Hypoglycemic Episodes Participants who had at least one hypoglycemic events (<70 mg/dl)	18 Participants	31 Participants
Hypoglycemic Episodes Participants who had at least one severe hypoglycemic event (<40 mg/dl)	2 Participants	3 Participants

SECONDARY outcome

Timeframe: After discharge, average 6 months

Population: This outcome included only participants with available data for both variables: HbA1c and hypoglycemia

Percent of patients with 26 week HbA1c <7.0% and no hypoglycemia

Outcome measures

Measure	Liraglutide + OADs n=76 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=88 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
HbA1c <7.0% and no Hypoglycemia	34 Participants	29 Participants

SECONDARY outcome

Timeframe: After discharge, average 6 months

Population: This outcome included only participants with available data for both variables: HbA1c and weight

Percent of patients with 26 week HbA1c <7.0% and no weight gain

Outcome measures

Measure	Liraglutide + OADs n=78 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=90 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
HbA1c <7.0% and no Weight Gain	32 Participants	21 Participants

SECONDARY outcome

Timeframe: After discharge, average 12 weeks

Percent of patients with 12 week HbA1c <7.0% and no hypoglycemia

Outcome measures

Measure	Liraglutide + OADs n=83 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=94 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
HbA1c <7.0% and no Hypoglycemia	40 Participants	31 Participants

SECONDARY outcome

Timeframe: After discharge, average 6 months

Population: This outcome only included participants with available data for body weight in Kgs at baseline and 26 weeks follow up.

Change in body weight from baseline after 6 months of follow up (26 weeks)

Outcome measures

Measure	Liraglutide + OADs n=73 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=91 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Change in Body Weight From Baseline Weight at six months	97.2 Kgs Standard Deviation 19.9	98.3 Kgs Standard Deviation 22.1
Change in Body Weight From Baseline Weight change from baseline (discharge) to 6 months after discharge	-4.77 Kgs Standard Deviation 8	0.6 Kgs Standard Deviation 11
Change in Body Weight From Baseline Baseline weight at discharge	101.0 Kgs Standard Deviation 20.6	98.2 Kgs Standard Deviation 18.0

SECONDARY outcome

Timeframe: Baseline, and follow up after discharge (average 6 months)

Population: This outcome only included participants with available data for BMI at baseline and follow up of 26 weeks.

Change in BMI after 6 months from baseline

Outcome measures

Measure	Liraglutide + OADs n=136 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=137 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Change in BMI Baseline BMI	33.5 kg/m2 Standard Deviation 5.3	33.3 kg/m2 Standard Deviation 5.3
Change in BMI BMI at 26 weeks follow up	32.7 kg/m2 Standard Deviation 6.8	33.3 kg/m2 Standard Deviation 6.2

SECONDARY outcome

Timeframe: After discharge, average 6 months

Population: This outcome analyzed participants with available medication dose for the 26 weeks follow up.

Evaluate the total daily dose of insulin needed in the group receiving glargine

Outcome measures

Measure	Liraglutide + OADs n=73 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=90 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Total Daily Dose of Insulin	0 IU per day Standard Deviation 0	20.9 IU per day Standard Deviation 11.1

SECONDARY outcome

Timeframe: Baseline, 26 weeks post-intervention

Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention

Outcome measures

Measure	Liraglutide + OADs n=73 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=90 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Change in Cardiovascular Risk Factors: Blood Pressure Systolic blood pressure at baseline	134 mmHg Standard Deviation 17	130 mmHg Standard Deviation 17
Change in Cardiovascular Risk Factors: Blood Pressure Systolic blood pressure at 26 weeks follow up	136 mmHg Standard Deviation 22	135 mmHg Standard Deviation 19
Change in Cardiovascular Risk Factors: Blood Pressure Diastolic blood pressure at baseline	79 mmHg Standard Deviation 11	77 mmHg Standard Deviation 12
Change in Cardiovascular Risk Factors: Blood Pressure Diastolic blood pressure at 26 weeks follow up	80 mmHg Standard Deviation 13	79 mmHg Standard Deviation 14

SECONDARY outcome

Timeframe: 26 weeks post-intervention

Population: This outcome included patients with available heart rate data at 26 weeks follow-up.

Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention

Outcome measures

Measure	Liraglutide + OADs n=73 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=90 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Cardiovascular Risk Factor: Heart Rate Heart rate at baseline (discharge)	79 beats/min Standard Deviation 14	79 beats/min Standard Deviation 14
Cardiovascular Risk Factor: Heart Rate Heart rate at 6 months post-discharge	83 beats/min Standard Deviation 13	79 beats/min Standard Deviation 14

SECONDARY outcome

Timeframe: 26 weeks post-intervention

Population: Total cholesterol was measured in 9 subjects only due to limited funding.

Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care.

Outcome measures

Measure	Liraglutide + OADs n=4 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=5 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Cardiovascular Risk Factor: Lipid Profile	190 mg/dL Standard Deviation 6	130 mg/dL Standard Deviation 56

SECONDARY outcome

Timeframe: After discharge, average 6 months

Number of participants who had at least one emergency room visit and hospital readmissions

Outcome measures

Measure	Liraglutide + OADs n=136 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=137 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Emergency Room Visits and Readmissions Number of participants with at least one ER visit	31 Participants	23 Participants
Emergency Room Visits and Readmissions Number of participants with at least one hospital readmission	35 Participants	43 Participants

SECONDARY outcome

Timeframe: After discharge, average 6 months

Acute renal failure during the 26-week follow-up defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment in creatinine > 0.5 mg/dL from baseline)

Outcome measures

Measure	Liraglutide + OADs n=136 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=137 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Acute Renal Failure	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 26 weeks post-intervention

Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up

Outcome measures

Measure	Liraglutide + OADs n=136 Participants Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=137 Participants Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up	34 Participants	34 Participants

Adverse Events

Liraglutide + OADs

Serious events: 52 serious events

Other events: 0 other events

Deaths: 2 deaths

Glargine + OADs

Serious events: 54 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Liraglutide + OADs n=136 participants at risk Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine + OADs n=137 participants at risk Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
General disorders Readmissions	25.7% 35/136 • Number of events 60 • Data collected during follow up (6 months post-intervention).	31.4% 43/137 • Number of events 94 • Data collected during follow up (6 months post-intervention).
Cardiac disorders Congestive heart failure	8.8% 12/136 • Number of events 21 • Data collected during follow up (6 months post-intervention).	9.5% 13/137 • Number of events 34 • Data collected during follow up (6 months post-intervention).
General disorders Medication discontinued due to AEs	9.6% 13/136 • Number of events 13 • Data collected during follow up (6 months post-intervention).	0.00% 0/137 • Data collected during follow up (6 months post-intervention).
Nervous system disorders Cerebrovascular event	0.00% 0/136 • Data collected during follow up (6 months post-intervention).	2.2% 3/137 • Number of events 3 • Data collected during follow up (6 months post-intervention).
Renal and urinary disorders Acute kidney injury	0.74% 1/136 • Number of events 1 • Data collected during follow up (6 months post-intervention).	2.2% 3/137 • Number of events 3 • Data collected during follow up (6 months post-intervention).
Cardiac disorders Acute myocardial infarction	0.00% 0/136 • Data collected during follow up (6 months post-intervention).	0.73% 1/137 • Number of events 1 • Data collected during follow up (6 months post-intervention).
Gastrointestinal disorders Nausea	27.2% 37/136 • Number of events 37 • Data collected during follow up (6 months post-intervention).	2.2% 3/137 • Number of events 3 • Data collected during follow up (6 months post-intervention).
Gastrointestinal disorders Vomiting	13.2% 18/136 • Number of events 18 • Data collected during follow up (6 months post-intervention).	0.00% 0/137 • Data collected during follow up (6 months post-intervention).

Other adverse events

Adverse event data not reported

Additional Information

Dr. Francisco Pasquel

Emory University

Phone: 404-778-1695

Email: fpasque@emory.edu

Results disclosure agreements

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