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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00071946 | Other Identifier | VA site IRB number |
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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin glargine | Active Comparator | Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. |
|
| linagliptin | Experimental | Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linagliptin | Drug | 5mg linagliptin tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Fasting Blood Glucose Level | The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c at 6 month | 6 months |
| Number of Hypoglycemic Events < 70mg/dl | total number of hypoglycemic events (<70 mg/dl) | over 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crestvew Nursing Home | Atlanta | Georgia | 30315 | United States | ||
| Budd Terrace Nursing Home |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29289540 | Derived | Umpierrez GE, Cardona S, Chachkhiani D, Fayfman M, Saiyed S, Wang H, Vellanki P, Haw JS, Olson DE, Pasquel FJ, Johnson TM 2nd. A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial. J Am Med Dir Assoc. 2018 May;19(5):399-404.e3. doi: 10.1016/j.jamda.2017.11.002. Epub 2017 Dec 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Glargine | Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. Insulin glargine |
| FG001 | Linagliptin | Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. linagliptin: 5mg linagliptin tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Glargine | Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. Insulin glargine. |
| BG001 | Linagliptin |
| 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 | Mean Fasting Blood Glucose Level | The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes. | Posted | Mean | Standard Deviation | mg/dl | 6 months |
|
6 months
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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 | Insulin Glargine | Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. Insulin glargine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized for Altered Mental Status | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saumeth Cardona MD | Emory University | 404-616-4827 | scardon@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 | Aug 11, 2017 | Jul 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| insulin glargine | Drug |
|
|
| Number of Hypoglycemic Events < 40mg/dl | total number of severe hypoglycemia (< 40 mg/dl). | over 6 months |
| Total Daily Dose of Insulin | Total daily dose of insulin (units) | over 6 months |
| Changes in Cognitive Function | Data on changes in cognitive function were not collected | over 6 months |
| Number of Participants With Acute Complications | Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection). | over 6 months |
| Total Number of Emergency Room Visits | Total number of emergency room visits during the study period | 6 months |
| Total Number of Hospital Visits | Total number of hospital visits during the study period | 6 months |
| Total Number of Complications | Total number of complications including urinary tract infections, pneumonia, diabetic foot infection, cardiac complications including myocardial infarction and heart failure, cerebrovascular accidents, and acute kidney injury and mortality. | 6 months |
| Incidence of Acute Kidney Injury | Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy | over 6 months |
| Mortality | Mortality is defined as death occurring during admission at the LTC facility | over 6 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Wesley Woods Nursing Home | Atlanta | Georgia | 30322 | United States |
| VA Nursing Home | Decatur | Georgia | 30033 | United States |
Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.
linagliptin: 5mg linagliptin tablets.
| 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 |
|
|
|
| Secondary | HbA1c | HbA1c at 6 month | Posted | Mean | Standard Deviation | percent of glycosylated hemoglobin | 6 months |
|
|
|
| Secondary | Number of Hypoglycemic Events < 70mg/dl | total number of hypoglycemic events (<70 mg/dl) | Posted | Number | events | over 6 months |
|
|
|
| Secondary | Number of Hypoglycemic Events < 40mg/dl | total number of severe hypoglycemia (< 40 mg/dl). | Posted | Number | events | over 6 months |
|
|
|
| Secondary | Total Daily Dose of Insulin | Total daily dose of insulin (units) | Posted | Mean | Standard Deviation | U/day | over 6 months |
|
|
|
| Secondary | Changes in Cognitive Function | Data on changes in cognitive function were not collected | Data were not collected | Posted | over 6 months |
|
|
| Secondary | Number of Participants With Acute Complications | Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection). | Posted | Count of Participants | Participants | over 6 months |
|
|
|
| Secondary | Total Number of Emergency Room Visits | Total number of emergency room visits during the study period | Posted | Number | visits | 6 months |
|
|
|
| Secondary | Total Number of Hospital Visits | Total number of hospital visits during the study period | Posted | Number | visits | 6 months |
|
|
|
| Secondary | Total Number of Complications | Total number of complications including urinary tract infections, pneumonia, diabetic foot infection, cardiac complications including myocardial infarction and heart failure, cerebrovascular accidents, and acute kidney injury and mortality. | Posted | Number | events | 6 months |
|
|
|
| Secondary | Incidence of Acute Kidney Injury | Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy | Posted | Number | events | over 6 months |
|
|
|
| Secondary | Mortality | Mortality is defined as death occurring during admission at the LTC facility | Posted | Count of Participants | Participants | over 6 months |
|
|
|
| 0 |
| 73 |
| 6 |
| 73 |
| 16 |
| 73 |
| EG001 | Linagliptin | Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. linagliptin: 5mg linagliptin tablets | 2 | 67 | 4 | 67 | 12 | 67 |
| Hospitalized for repair craninectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Hospitalized for aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalization for pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hospitalization for congestive heart failure ( exacerbation | Cardiac disorders | Non-systematic Assessment |
|
| Right stump infection | Infections and infestations | Non-systematic Assessment |
|
| Hospitalized for brain edema | Nervous system disorders | Non-systematic Assessment |
|
| Hospitalized for severe aortic stenosis | Cardiac disorders | Non-systematic Assessment |
|
| Amputation of the left 2nd toe | Surgical and medical procedures | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | Non-systematic Assessment |
|
| Shingels | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Bradicardia | Cardiac disorders | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Penile infection | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D011799 | Quinazolines |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |