Primary outcomeMean· Hospital discharge, 6 months (26 weeks)
Glycemic Control at Hospital Discharge and 6 Months Follow up
| Group | Value (% (mmol/mol)) | Spread |
|---|---|---|
| Liraglutide + OADs | 8.3 | 0.9 |
| Glargine + OADs | 8.4 | 0.8 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataLiraglutide Hospital Discharge Trial
NCTNCT01919489 (opens ClinicalTrials.gov in a new tab)Other idIRB00068128Other id(UTN) U1111-1139-2991
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 273 participants (actual)
- Sponsor
- Emory University · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Mar 2014
- Primary completion
- 30 Aug 2020
- Completion
- 30 Aug 2020
- First posted
- 9 Aug 2013 (estimated)
- Last update posted
- 3 Nov 2021
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2014201620182020
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Liraglutide + OADsDrug
- Glargine + OADsDrug
Arms2
Experimental
Liraglutide + OADs
Liraglutide once daily in combination to oral anti-diabetic agents (OADs)
Active comparator
Glargine + OADs
Glargine once daily in combination to oral anti-diabetic agents (OADs)
Primary outcomes1
Outcomes the sponsor listed as primary.
Glycemic Control at Hospital Discharge and 6 Months Follow up
Time frame · Hospital discharge, 6 months (26 weeks)
Registry description
To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy
Secondary outcomes(14)
Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks
Time frame · After discharge, average at 3 months (12 week) and 6 months (26 weeks)
Registry description
To determine differences in BG concentration between liraglutide and glargine insulin therapy
Hypoglycemic Episodes
Time frame · After discharge, average 6 months
Registry description
Number of participants who had at least one hypoglycemic event (\<70 mg/dl) and severe hypoglycemic event (\<40 mg/dl)
HbA1c <7.0% and no Hypoglycemia
Time frame · After discharge, average 6 months
Registry description
Percent of patients with 26 week HbA1c \<7.0% and no hypoglycemia
HbA1c <7.0% and no Weight Gain
Time frame · After discharge, average 6 months
Registry description
Percent of patients with 26 week HbA1c \<7.0% and no weight gain
HbA1c <7.0% and no Hypoglycemia
Time frame · After discharge, average 12 weeks
Registry description
Percent of patients with 12 week HbA1c \<7.0% and no hypoglycemia
Change in Body Weight From Baseline
Time frame · After discharge, average 6 months
Registry description
Change in body weight from baseline after 6 months of follow up (26 weeks)
Change in BMI
Time frame · Baseline, and follow up after discharge (average 6 months)
Registry description
Change in BMI after 6 months from baseline
Total Daily Dose of Insulin
Time frame · After discharge, average 6 months
Registry description
Evaluate the total daily dose of insulin needed in the group receiving glargine
Change in Cardiovascular Risk Factors: Blood Pressure
Time frame · Baseline, 26 weeks post-intervention
Registry description
Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention
Cardiovascular Risk Factor: Heart Rate
Time frame · 26 weeks post-intervention
Registry description
Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention
Cardiovascular Risk Factor: Lipid Profile
Time frame · 26 weeks post-intervention
Registry description
Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care.
Emergency Room Visits and Readmissions
Time frame · After discharge, average 6 months
Registry description
Number of participants who had at least one emergency room visit and hospital readmissions
Acute Renal Failure
Time frame · After discharge, average 6 months
Registry 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)
Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up
Time frame · 26 weeks post-intervention
Registry description
Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· After discharge, average at 3 months (12 week) and 6 months (26 weeks)
Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Liraglutide + OADs | 7.61 | 2.2 |
| Glargine + OADs | 8.56 | 3.8 |
Secondary outcomeCount of participants· After discharge, average 6 months
Hypoglycemic Episodes
| Group | Value (Participants) |
|---|---|
| Liraglutide + OADs | 18 |
| Glargine + OADs | 31 |
Secondary outcomeCount of participants· After discharge, average 6 months
HbA1c <7.0% and no Hypoglycemia
| Group | Value (Participants) |
|---|---|
| Liraglutide + OADs | 34 |
| Glargine + OADs | 29 |
Secondary outcomeCount of participants· After discharge, average 6 months
HbA1c <7.0% and no Weight Gain
| Group | Value (Participants) |
|---|---|
| Liraglutide + OADs | 32 |
| Glargine + OADs | 21 |
Secondary outcomeCount of participants· After discharge, average 12 weeks
HbA1c <7.0% and no Hypoglycemia
| Group | Value (Participants) |
|---|---|
| Liraglutide + OADs | 40 |
| Glargine + OADs | 31 |
Secondary outcomeMean· After discharge, average 6 months
Change in Body Weight From Baseline
| Group | Value (Kgs) | Spread |
|---|---|---|
| Liraglutide + OADs | 101.0 | 20.6 |
| Glargine + OADs | 98.2 | 18.0 |
Secondary outcomeMean· Baseline, and follow up after discharge (average 6 months)
Change in BMI
| Group | Value (kg/m2) | Spread |
|---|---|---|
| Liraglutide + OADs | 33.5 | 5.3 |
| Glargine + OADs | 33.3 | 5.3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Liraglutide + OADsLiraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily | 2 / 136 | 52 / 136 | 0 / 136 |
| Glargine + OADsGlargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously | 1 / 137 | 54 / 137 | 0 / 137 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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).
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