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| ID | Type | Description | Link |
|---|---|---|---|
| (UTN) U1111-1139-2991 | Registry Identifier | UNIVERSAL TRIAL NUMBER |
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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide + OADs | Experimental | Liraglutide once daily in combination to oral anti-diabetic agents (OADs) |
|
| Glargine + OADs | Active Comparator | Glargine once daily in combination to oral anti-diabetic agents (OADs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide + OADs | Drug | Liraglutide subcutaneously daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control at Hospital Discharge and 6 Months Follow up | To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy | Hospital discharge, 6 months (26 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks | To determine differences in BG concentration between liraglutide and glargine insulin therapy | After discharge, average at 3 months (12 week) and 6 months (26 weeks) |
| Hypoglycemic Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo E Umpierrez, MD | Emory University SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | United States | |||
| Grady Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide + OADs | Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily |
| FG001 | Glargine + OADs | Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide + OADs | Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily |
| BG001 | Glargine + OADs | Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Control at Hospital Discharge and 6 Months Follow up | To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy | 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. | Posted | Mean | Standard Deviation | % (mmol/mol) | Hospital discharge, 6 months (26 weeks) |
|
Data collected during follow up (6 months post-intervention).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide + OADs | Liraglutide once daily in combination to oral anti-diabetic agents (OADs) Liraglutide + OADs: Liraglutide subcutaneously daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmissions | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco Pasquel | Emory University | 404-778-1695 | fpasque@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2019 | Aug 19, 2021 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Glargine + OADs | Drug | Glargine once daily subcutaneously |
|
|
Number of participants who had at least one hypoglycemic event (<70 mg/dl) and severe hypoglycemic event (<40 mg/dl) |
| After discharge, average 6 months |
| HbA1c <7.0% and no Hypoglycemia | Percent of patients with 26 week HbA1c <7.0% and no hypoglycemia | After discharge, average 6 months |
| HbA1c <7.0% and no Weight Gain | Percent of patients with 26 week HbA1c <7.0% and no weight gain | After discharge, average 6 months |
| HbA1c <7.0% and no Hypoglycemia | Percent of patients with 12 week HbA1c <7.0% and no hypoglycemia | After discharge, average 12 weeks |
| Change in Body Weight From Baseline | Change in body weight from baseline after 6 months of follow up (26 weeks) | After discharge, average 6 months |
| Change in BMI | Change in BMI after 6 months from baseline | Baseline, and follow up after discharge (average 6 months) |
| Total Daily Dose of Insulin | Evaluate the total daily dose of insulin needed in the group receiving glargine | After discharge, average 6 months |
| Change in Cardiovascular Risk Factors: Blood Pressure | Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention | Baseline, 26 weeks post-intervention |
| Cardiovascular Risk Factor: Heart Rate | Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention | 26 weeks post-intervention |
| Cardiovascular Risk Factor: Lipid Profile | Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care. | 26 weeks post-intervention |
| Emergency Room Visits and Readmissions | Number of participants who had at least one emergency room visit and hospital readmissions | After discharge, average 6 months |
| Acute Renal Failure | 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) | After discharge, average 6 months |
| Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up | Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up | 26 weeks post-intervention |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30324 | United States |
| Emory Universtiy Hospital at MIdtown | Atlanta | Georgia | United States |
| State University of NY at Buffalo | New York | New York | United States |
| Hospital readmission |
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| Death |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Glargine once daily in combination to oral anti-diabetic agents (OADs)
Glargine + OADs: Glargine once daily subcutaneously
|
|
| Secondary | Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks | To determine differences in BG concentration between liraglutide and glargine insulin therapy | 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). | Posted | Mean | Standard Deviation | mmol/L | After discharge, average at 3 months (12 week) and 6 months (26 weeks) |
|
|
|
| Secondary | Hypoglycemic Episodes | Number of participants who had at least one hypoglycemic event (<70 mg/dl) and severe hypoglycemic event (<40 mg/dl) | Posted | Count of Participants | Participants | After discharge, average 6 months |
|
|
|
| Secondary | HbA1c <7.0% and no Hypoglycemia | Percent of patients with 26 week HbA1c <7.0% and no hypoglycemia | This outcome included only participants with available data for both variables: HbA1c and hypoglycemia | Posted | Count of Participants | Participants | After discharge, average 6 months |
|
|
|
| Secondary | HbA1c <7.0% and no Weight Gain | Percent of patients with 26 week HbA1c <7.0% and no weight gain | This outcome included only participants with available data for both variables: HbA1c and weight | Posted | Count of Participants | Participants | After discharge, average 6 months |
|
|
|
| Secondary | HbA1c <7.0% and no Hypoglycemia | Percent of patients with 12 week HbA1c <7.0% and no hypoglycemia | Posted | Count of Participants | Participants | After discharge, average 12 weeks |
|
|
|
| Secondary | Change in Body Weight From Baseline | Change in body weight from baseline after 6 months of follow up (26 weeks) | This outcome only included participants with available data for body weight in Kgs at baseline and 26 weeks follow up. | Posted | Mean | Standard Deviation | Kgs | After discharge, average 6 months |
|
|
|
| Secondary | Change in BMI | Change in BMI after 6 months from baseline | This outcome only included participants with available data for BMI at baseline and follow up of 26 weeks. | Posted | Mean | Standard Deviation | kg/m2 | Baseline, and follow up after discharge (average 6 months) |
|
|
|
| Secondary | Total Daily Dose of Insulin | Evaluate the total daily dose of insulin needed in the group receiving glargine | This outcome analyzed participants with available medication dose for the 26 weeks follow up. | Posted | Mean | Standard Deviation | IU per day | After discharge, average 6 months |
|
|
|
| Secondary | Change in Cardiovascular Risk Factors: Blood Pressure | Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention | Posted | Mean | Standard Deviation | mmHg | Baseline, 26 weeks post-intervention |
|
|
|
| Secondary | Cardiovascular Risk Factor: Heart Rate | Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention | This outcome included patients with available heart rate data at 26 weeks follow-up. | Posted | Mean | Standard Deviation | beats/min | 26 weeks post-intervention |
|
|
|
| Secondary | Cardiovascular Risk Factor: Lipid Profile | Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care. | Total cholesterol was measured in 9 subjects only due to limited funding. | Posted | Mean | Standard Deviation | mg/dL | 26 weeks post-intervention |
|
|
|
| Secondary | Emergency Room Visits and Readmissions | Number of participants who had at least one emergency room visit and hospital readmissions | Posted | Count of Participants | Participants | After discharge, average 6 months |
|
|
|
| Secondary | Acute Renal Failure | 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) | Posted | Count of Participants | Participants | After discharge, average 6 months |
|
|
|
| Secondary | Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up | Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up | Posted | Count of Participants | Participants | 26 weeks post-intervention |
|
|
|
| 2 |
| 136 |
| 52 |
| 136 |
| 0 |
| 136 |
| EG001 | Glargine + OADs | Glargine once daily in combination to oral anti-diabetic agents (OADs) Glargine + OADs: Glargine once daily subcutaneously | 1 | 137 | 54 | 137 | 0 | 137 |
| Congestive heart failure | Cardiac disorders | Non-systematic Assessment |
|
| Medication discontinued due to AEs | General disorders | Non-systematic Assessment |
|
| Cerebrovascular event | Nervous system disorders | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Post-prandial blood glucose at 12 weeks |
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| Postprandial blood glucose at 26 weeks follow up |
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| Fasting blood glucose at 12 weeks |
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| Weight change from baseline (discharge) to 6 months after discharge |
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| BMI at 26 weeks follow up |
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| Diastolic blood pressure at baseline |
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| Diastolic blood pressure at 26 weeks follow up |
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