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This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 10773 | Experimental | Oral once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 | Drug | Oral once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia | The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia | Baseline and 8 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.46.10001 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32200854 | Derived | van Bommel EJM, Lytvyn Y, Perkins BA, Soleymanlou N, Fagan NM, Koitka-Weber A, Joles JA, Cherney DZI, van Raalte DH. Renal hemodynamic effects of sodium-glucose cotransporter 2 inhibitors in hyperfiltering people with type 1 diabetes and people with type 2 diabetes and normal kidney function. Kidney Int. 2020 Apr;97(4):631-635. doi: 10.1016/j.kint.2019.12.021. No abstract available. | |
| 26544192 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Empagliflozin (BI 10773) 25 mg | Oral once daily Empagliflozin 25 mg: Oral once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Empagliflozin (BI 10773) 25 mg | Oral once daily Empagliflozin 25 mg: Oral once daily |
| 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 | Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia | The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia | Per protocol set for renal (PPS_RENAL) consists of all patients who were treated with study drug and had a baseline measurement and evaluable post-dosing renal data under the clamped hyperglycemia condition for the primary endpoint. | Posted | Mean | Standard Error | mL/min/1.73 m^2 | Baseline and 8 weeks |
|
8 weeks
All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
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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 | Empagliflozin 25 mg | Oral once daily Empagliflozin 25 mg: Oral once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Derived |
| Perkins BA, Cherney DZ, Soleymanlou N, Lee JA, Partridge H, Tschirhart H, Zinman B, Mazze R, Fagan N, Kaspers S, Woerle HJ, Broedl UC, Johansen OE. Diurnal Glycemic Patterns during an 8-Week Open-Label Proof-of-Concept Trial of Empagliflozin in Type 1 Diabetes. PLoS One. 2015 Nov 6;10(11):e0141085. doi: 10.1371/journal.pone.0141085. eCollection 2015. |
| 24595630 | Derived | Perkins BA, Cherney DZ, Partridge H, Soleymanlou N, Tschirhart H, Zinman B, Fagan NM, Kaspers S, Woerle HJ, Broedl UC, Johansen OE. Sodium-glucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-of-concept trial. Diabetes Care. 2014 May;37(5):1480-3. doi: 10.2337/dc13-2338. Epub 2014 Mar 4. |
| 24475922 | Derived | Cherney DZ, Perkins BA, Soleymanlou N, Har R, Fagan N, Johansen OE, Woerle HJ, von Eynatten M, Broedl UC. The effect of empagliflozin on arterial stiffness and heart rate variability in subjects with uncomplicated type 1 diabetes mellitus. Cardiovasc Diabetol. 2014 Jan 29;13:28. doi: 10.1186/1475-2840-13-28. |
| 24334175 | Derived | Cherney DZ, Perkins BA, Soleymanlou N, Maione M, Lai V, Lee A, Fagan NM, Woerle HJ, Johansen OE, Broedl UC, von Eynatten M. Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus. Circulation. 2014 Feb 4;129(5):587-97. doi: 10.1161/CIRCULATIONAHA.113.005081. Epub 2013 Dec 13. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Hyperfilterers (Empagliflozin 25 mg) |
Hyperfilterers Empagliflozin 25 mg: Oral once daily hyperfilterers = GFRs of ≥135 mL/min/1.73m2 |
| OG002 | Non-hyperfilterers (Empagliflozin 25 mg) | Non-hyperfilterers Empagliflozin 25 mg: Oral once daily non-hyperfilterers = GFRs of ≥60 mL/min/1.73m2 to <135 mL/min/1.73m2 |
|
|
|
| 3 |
| 42 |
| 42 |
| 42 |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Thirst | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Genitourinary tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |