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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
| Medtronic | INDUSTRY |
| Abbott | INDUSTRY |
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The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with a sulfonylurea, improves time in normal blood glucose range and reduces blood glucose variability. Blood glucose is measured using a continuous glucose monitoring device.
This is a proof-of-concept clinical trial testing the effects of linagliptin versus glipizide on glucose variability among people with type 2 diabetes and stage 3-4 CKD. In a cross-over design, each enrolled participant will receive 28 days of each study medication. Study medications will be provided in a randomly assigned order without blinding. The primary study outcome is glucose time in range, measured by blinded continuous glucose monitoring for the last 6 days of each 28-day treatment period. Secondary outcomes include indices of glycemic variability, hypoglycemia, and biomarkers of systemic inflammation, oxidative stress, and albuminuria. The overall goal of this research is to identify safe and effective treatments to control glycemia among patients with diabetes and CKD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin/Glipizide | Experimental | Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide |
|
| Glipizide/Linagliptin | Experimental | Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug | Receives 4 weeks of study drug linagliptin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Time in Range | Time with glucose 70-140 mg/dL | last 6 days of each 28-day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Variability | SD of glucose readings | last 6 days of each 28-day treatment period |
| Hypoglycemia | Glucose <70 mg/dL for at least 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian de Boer, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Linagliptin/Glipizide | Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide |
| FG001 | Glipizide/Linagliptin | Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Linagliptin/Glipizide | Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide |
| BG001 | Glipizide/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 | Glucose Time in Range | Time with glucose 70-140 mg/dL | Posted | Mean | Standard Deviation | minutes per day | last 6 days of each 28-day treatment period |
|
|
AE information collected over 8 weeks of the study
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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 | Linagliptin/Glipizide | Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian de Boer, Associate Director | Kidney Research Institute, University of Washington | 2067444029 | IDeBoer@Nephrology.washington.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 | Sep 28, 2015 | Aug 9, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| D005913 | Glipizide |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Glipizide | Drug | Receives 4 weeks of study drug glipizide |
|
| last 6 days of each 28-day treatment period |
| Biomarkers of Systemic Inflammation | Measured by plasma C-reactive protein (CRP) | last 6 days of each 28-day treatment period |
| Biomarkers of Systemic Inflammation | Measured by plasma interleukin-6 | last 6 days of each 28-day treatment period |
| Biomarkers of Oxidative Stress | Measured by plasma F2-isoprostanes | last 6 days of each 28-day treatment period |
| Biomarkers of Oxidative Stress | Measured by urine F2-isoprostanes | last 6 days of each 28-day treatment period |
| Biomarkers of Albuminuria | Measured by albumin-creatinine ratio | last 6 days of each 28-day treatment period |
Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Glycemic Variability | SD of glucose readings | Posted | Mean | Standard Deviation | mg/dL | last 6 days of each 28-day treatment period |
|
|
|
| Secondary | Hypoglycemia | Glucose <70 mg/dL for at least 10 minutes | Posted | Number | events | last 6 days of each 28-day treatment period |
|
|
|
| Secondary | Biomarkers of Systemic Inflammation | Measured by plasma C-reactive protein (CRP) | Labs not run due to small sample size. | Posted | last 6 days of each 28-day treatment period |
|
|
| Secondary | Biomarkers of Systemic Inflammation | Measured by plasma interleukin-6 | Labs not run due to small sample size. | Posted | last 6 days of each 28-day treatment period |
|
|
| Secondary | Biomarkers of Oxidative Stress | Measured by plasma F2-isoprostanes | Labs not run due to small sample size. | Posted | last 6 days of each 28-day treatment period |
|
|
| Secondary | Biomarkers of Oxidative Stress | Measured by urine F2-isoprostanes | Labs not run due to small sample size. | Posted | last 6 days of each 28-day treatment period |
|
|
| Secondary | Biomarkers of Albuminuria | Measured by albumin-creatinine ratio | Labs not run due to small sample size. | Posted | last 6 days of each 28-day treatment period |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Glipizide/Linagliptin | Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin Linagliptin: Receives 4 weeks of study drug linagliptin Glipizide: Receives 4 weeks of study drug glipizide | 0 | 1 | 0 | 1 | 0 | 1 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011799 | Quinazolines |
| D013453 | Sulfonylurea Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |