Liraglutide Hospital Discharge Trial

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01919489
• Collaborator: Novo Nordisk A/S (Industry)
• Enrollment: 273
• Locations: 5
• Arms: 2
• Actual Duration (Months): 78
• Patients Per Site: 54.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Increasing evidence indicates that incretin-based agents are safe and effective for the hospital management of patients with type 2 diabetes (T2D).

Liraglutide is a once-daily human glucagon-like peptide (GLP-1) analogue approved for the treatment of T2D. Liraglutide has been shown to lower blood glucose, stimulate endogenous insulin secretion, decrease plasma glucagon levels, inhibit gastric emptying, reduce food intake and body weight and improve ß-cell function when administered subcutaneously. Liraglutide increases insulin secretion in a glucose-dependent manner (i.e., only when plasma glucose levels are elevated), resulting in low-risk of hypoglycemia when used as monotherapy. When compared to insulin glargine therapy, the use of GLP-1 has resulted in comparable reduction in HbA1c level, lower rates of hypoglycemia and less weight gain. No prospective studies; however, have compared the efficacy and safety of liraglutide in the hospital setting or after hospital discharge.

The primary objective is to compare the safety and efficacy of liraglutide (Victoza®) versus glargine insulin in combination to oral anti-diabetic agents (OADs: metformin, sulfonylureas, nateglinide, repaglinide or pioglitazone) on glycemic control after 26 weeks of treatment in medicine patients with T2D after hospital discharge.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Liraglutide + OADs; Drug: Glargine + OADs	Phase 4

Detailed Description

Specific Aim: To determine whether treatment with liraglutide (Victoza®) will result in similar glycemic control (HbA1c at 26 weeks) and a lower rate of hypoglycemic events compared to treatment with glargine (Lantus®) in patients with T2D after hospital discharge. Patients with poorly controlled (HbA1c >7%-10%) T2D treated with diet or oral antidiabetic agents or low dose insulin naïve (0.4u/kg/day) prior to admission will be randomized to liraglutide or glargine in combination to OADs at hospital discharge.

Study Design

• Study Type: Interventional
• Actual Enrollment: 273 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial Comparing the Safety and Efficacy of Liraglutide Versus Glargine Insulin for the Management of Patients With Type 2 Diabetes After Hospital Discharge
• Actual Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Aug 30, 2020
• Actual Study Completion Date: Aug 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liraglutide + OADs Liraglutide once daily in combination to oral anti-diabetic agents (OADs)	Drug: Liraglutide + OADs; Liraglutide subcutaneously daily; Other Names: Victoza® + OADs
Active Comparator: Glargine + OADs Glargine once daily in combination to oral anti-diabetic agents (OADs)	Drug: Glargine + OADs; Glargine once daily subcutaneously; Other Names: Glargine (Lantus®) + OADs

Outcome Measures

Primary Outcome Measures

1. Glycemic Control at Hospital Discharge and 6 Months Follow up [Hospital discharge, 6 months (26 weeks)]

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

Secondary Outcome Measures

1. Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks [After discharge, average at 3 months (12 week) and 6 months (26 weeks)]

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

2. Hypoglycemic Episodes [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)

3. HbA1c <7.0% and no Hypoglycemia [After discharge, average 6 months]

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

4. HbA1c <7.0% and no Weight Gain [After discharge, average 6 months]

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

5. HbA1c <7.0% and no Hypoglycemia [After discharge, average 12 weeks]

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

6. Change in Body Weight From Baseline [After discharge, average 6 months]

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

7. Change in BMI [Baseline, and follow up after discharge (average 6 months)]

   Change in BMI after 6 months from baseline

8. Total Daily Dose of Insulin [After discharge, average 6 months]

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

9. Change in Cardiovascular Risk Factors: Blood Pressure [Baseline, 26 weeks post-intervention]

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

10. Cardiovascular Risk Factor: Heart Rate [26 weeks post-intervention]

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

11. Cardiovascular Risk Factor: Lipid Profile [26 weeks post-intervention]

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

12. Emergency Room Visits and Readmissions [After discharge, average 6 months]

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

13. Acute Renal Failure [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)

14. Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up [26 weeks post-intervention]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Males or females between the ages of 18 and 80 years discharged after hospital admission from non- ICU general surgery and medicine services (excluding gastrointestinal and cardiac surgeries).

2. Admission HbA1c between 7% and 10%

3. Patients with T2D treated with diet alone or with oral antidiabetic agents as monotherapy or in combination therapy (excluding GLP1 receptor agonists) or on low-dose insulin therapy (TDD ≤0.4 unit/kg/day) prior to admission.

4. Subjects with a hospital admission BG < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).

5. BMI > 25 Kg/m2 and ≤ 45 Kg/m2

Exclusion Criteria:

1. Age < 18 or > 80 years.

2. Subjects with stress hyperglycemia (BG > 140 mg/dL and HbA1c < 6.5%)

3. Subjects with a history of type 1 diabetes

4. Treatment with insulin or GLP-1 analogs during the past 3 months prior to admission.

5. Recurrent severe hypoglycemia or hypoglycemic unawareness.

6. Subjects with gastrointestinal obstruction, gastroparesis, or those expected to require gastrointestinal suction.

7. History of medullary thyroid cancer or multiple endocrine neoplasias

8. Patients with acute or chronic pancreatitis, pancreatic cancer, or gallbladder disease.

9. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 30 ml/min).

10. Treatment with oral or injectable corticosteroid (equivalent or higher than prednisone 5mg/day), parenteral nutrition, and immunosuppressive treatment.

11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

12. Female subjects who are pregnant or breastfeeding at the time of enrollment into the study.

13. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States
2	Grady Memorial Hospital	Atlanta	Georgia	United States	30303
3	Emory University Hospital	Atlanta	Georgia	United States	30324
4	Emory Universtiy Hospital at MIdtown	Atlanta	Georgia	United States
5	State University of NY at Buffalo	New York	New York	United States

Sponsors and Collaborators

• Emory University
• Novo Nordisk A/S

Investigators

• Principal Investigator: Guillermo E Umpierrez, MD, Emory University SOM

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 28, 2019

More Information

Publications

None provided.

• Responsible Party: Guillermo Umpierrez, MD, Professor of Medicine, Emory University
• ClinicalTrials.gov Identifier: NCT01919489
• Other Study ID Numbers: IRB00068128; (UTN) U1111-1139-2991
• First Posted: Aug 9, 2013
• Last Update Posted: Nov 3, 2021
• Last Verified: Aug 1, 2021

• Keywords provided by Guillermo Umpierrez, MD, Professor of Medicine, Emory University: Incretins; Liraglutide; Glargine; Randomized controlled trial; basal insulin; hospital discharge; inpatient diabetes
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Insulin Glargine; Liraglutide

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Liraglutide + OADs	Glargine + OADs	Total
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously	Total of all reporting groups
Overall Participants	136	137	273
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.1 (9.5)	55.9 (11.2)	56.1 (10.5)
Sex: Female, Male (Count of Participants)
Female	47 34.6%	61 44.5%	108 39.6%
Male	89 65.4%	76 55.5%	165 60.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	97 71.3%	95 69.3%	192 70.3%
White	23 16.9%	27 19.7%	50 18.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	16 11.8%	15 10.9%	31 11.4%
Region of Enrollment (participants) [Number]
United States	133 97.8%	134 97.8%	267 97.8%
Argentina	3 2.2%	3 2.2%	6 2.2%

Outcome Measures

1. Primary Outcome

Title	Glycemic Control at Hospital Discharge and 6 Months Follow up
Description	To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy
Time Frame	Hospital discharge, 6 months (26 weeks)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	136	137
HbA1C at hospital discharge	8.3 (0.9)	8.4 (0.8)
HbA1C at 6 months post-intervention	7.13 (1.3)	7.68 (1.69)

2. Secondary Outcome

Title	Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks
Description	To determine differences in BG concentration between liraglutide and glargine insulin therapy
Time Frame	After discharge, average at 3 months (12 week) and 6 months (26 weeks)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	60	79
Fasting blood glucose at 26 weeks follow up	7.61 (2.2)	8.56 (3.8)
Post-prandial blood glucose at 12 weeks	7.67 (1.6)	9.32 (8.8)
Postprandial blood glucose at 26 weeks follow up	8.23 (2.8)	8.72 (2.3)
Fasting blood glucose at 12 weeks	7.96 (3.3)	7.70 (2.6)

3. Secondary Outcome

Title	Hypoglycemic Episodes
Description	Number of participants who had at least one hypoglycemic event (<70 mg/dl) and severe hypoglycemic event (<40 mg/dl)
Time Frame	After discharge, average 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	136	137
Participants who had at least one hypoglycemic events (<70 mg/dl)	18 13.2%	31 22.6%
Participants who had at least one severe hypoglycemic event (<40 mg/dl)	2 1.5%	3 2.2%

4. Secondary Outcome

Title	HbA1c <7.0% and no Hypoglycemia
Description	Percent of patients with 26 week HbA1c <7.0% and no hypoglycemia
Time Frame	After discharge, average 6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	76	88
Count of Participants [Participants]	34 25%	29 21.2%

5. Secondary Outcome

Title	HbA1c <7.0% and no Weight Gain
Description	Percent of patients with 26 week HbA1c <7.0% and no weight gain
Time Frame	After discharge, average 6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	78	90
Count of Participants [Participants]	32 23.5%	21 15.3%

6. Secondary Outcome

Title	HbA1c <7.0% and no Hypoglycemia
Description	Percent of patients with 12 week HbA1c <7.0% and no hypoglycemia
Time Frame	After discharge, average 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	83	94
Count of Participants [Participants]	40 29.4%	31 22.6%

7. Secondary Outcome

Title	Change in Body Weight From Baseline
Description	Change in body weight from baseline after 6 months of follow up (26 weeks)
Time Frame	After discharge, average 6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	73	91
Baseline weight at discharge	101.0 (20.6)	98.2 (18.0)
Weight at six months	97.2 (19.9)	98.3 (22.1)
Weight change from baseline (discharge) to 6 months after discharge	-4.77 (8)	0.6 (11)

8. Secondary Outcome

Title	Change in BMI
Description	Change in BMI after 6 months from baseline
Time Frame	Baseline, and follow up after discharge (average 6 months)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	136	137
Baseline BMI	33.5 (5.3)	33.3 (5.3)
BMI at 26 weeks follow up	32.7 (6.8)	33.3 (6.2)

9. Secondary Outcome

Title	Total Daily Dose of Insulin
Description	Evaluate the total daily dose of insulin needed in the group receiving glargine
Time Frame	After discharge, average 6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	73	90
Mean (Standard Deviation) [IU per day]	0 (0)	20.9 (11.1)

10. Secondary Outcome

Title	Change in Cardiovascular Risk Factors: Blood Pressure
Description	Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention
Time Frame	Baseline, 26 weeks post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	73	90
Systolic blood pressure at baseline	134 (17)	130 (17)
Systolic blood pressure at 26 weeks follow up	136 (22)	135 (19)
Diastolic blood pressure at baseline	79 (11)	77 (12)
Diastolic blood pressure at 26 weeks follow up	80 (13)	79 (14)

11. Secondary Outcome

Title	Cardiovascular Risk Factor: Heart Rate
Description	Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention
Time Frame	26 weeks post-intervention

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	73	90
Heart rate at baseline (discharge)	79 (14)	79 (14)
Heart rate at 6 months post-discharge	83 (13)	79 (14)

12. Secondary Outcome

Title	Cardiovascular Risk Factor: Lipid Profile
Description	Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care.
Time Frame	26 weeks post-intervention

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	4	5
Mean (Standard Deviation) [mg/dL]	190 (6)	130 (56)

13. Secondary Outcome

Title	Emergency Room Visits and Readmissions
Description	Number of participants who had at least one emergency room visit and hospital readmissions
Time Frame	After discharge, average 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	136	137
Number of participants with at least one ER visit	31 22.8%	23 16.8%
Number of participants with at least one hospital readmission	35 25.7%	43 31.4%

14. Secondary Outcome

Title	Acute Renal Failure
Description	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)
Time Frame	After discharge, average 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	136	137
Count of Participants [Participants]	1 0.7%	3 2.2%

15. Secondary Outcome

Title	Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up
Description	Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up
Time Frame	26 weeks post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide + OADs	Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily	Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
Measure Participants	136	137
Count of Participants [Participants]	34 25%	34 24.8%

Adverse Events

Time Frame	Data collected during follow up (6 months post-intervention).
Arm/Group Title	Liraglutide + OADs		Glargine + OADs
Arm/Group Description	Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily		Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously
All Cause Mortality
	Liraglutide + OADs		Glargine + OADs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/136 (1.5%)		1/137 (0.7%)
Serious Adverse Events
	Liraglutide + OADs		Glargine + OADs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/136 (38.2%)		54/137 (39.4%)
Cardiac disorders
Congestive heart failure	12/136 (8.8%)	21	13/137 (9.5%)	34
Acute myocardial infarction	0/136 (0%)	0	1/137 (0.7%)	1
Gastrointestinal disorders
Nausea	37/136 (27.2%)	37	3/137 (2.2%)	3
Vomiting	18/136 (13.2%)	18	0/137 (0%)	0
General disorders
Readmissions	35/136 (25.7%)	60	43/137 (31.4%)	94
Medication discontinued due to AEs	13/136 (9.6%)	13	0/137 (0%)	0
Nervous system disorders
Cerebrovascular event	0/136 (0%)	0	3/137 (2.2%)	3
Renal and urinary disorders
Acute kidney injury	1/136 (0.7%)	1	3/137 (2.2%)	3
Other (Not Including Serious) Adverse Events
	Liraglutide + OADs		Glargine + OADs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/136 (0%)		0/137 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.