Type 2 Diabetes Mellitus Clinical Trial
— DERIVEOfficial title:
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycemic Efficacy and Renal Safety of Dapagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inadequate Glycemic Control.
| Verified date | September 2018 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.
| Status | Completed |
| Enrollment | 321 |
| Est. completion date | November 7, 2017 |
| Est. primary completion date | November 7, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 74 Years |
| Eligibility |
Inclusion Criteria: - Female or male aged =18 years and <75 years. - History of T2DM for more than 12 months. - Inadequate glycemic control, defined as HbA1c =7.0% and =11% - Stable anti-diabetic treatment regimen - Renal impairment: CKD 3A Exclusion Criteria: - Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period. - History of diabetic ketoacidosis or hyperosmolar nonketotic coma. - Severe uncontrolled hypertension defined as SBP =180 mmHg and/or Diastolic Blood Pressure (DBP) =110 mmHg - Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1: Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia. - History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis. - Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency. - Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening. - Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1. |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Research Site | Blagoevgrad | |
| Bulgaria | Research Site | Botevgrad | |
| Bulgaria | Research Site | Kozloduy | |
| Bulgaria | Research Site | Kyustendil | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Stara Zagora | |
| Canada | Research Site | Brampton | Ontario |
| Canada | Research Site | Cambridge | Ontario |
| Canada | Research Site | Concord | Ontario |
| Canada | Research Site | Courtice | Ontario |
| Canada | Research Site | Etobicoke | Ontario |
| Canada | Research Site | Guelph | Ontario |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | North York | Ontario |
| Canada | Research Site | Oakville | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Red Deer | Alberta |
| Canada | Research Site | Saskatoon | Saskatchewan |
| Canada | Research Site | Sudbury | Ontario |
| Canada | Research Site | Surrey | British Columbia |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Czechia | Research Site | Cheb | |
| Czechia | Research Site | Horovice | |
| Czechia | Research Site | Krnov | |
| Czechia | Research Site | Kutna Hora | |
| Czechia | Research Site | Ostrava | |
| Czechia | Research Site | Praha - Klanovice | |
| Czechia | Research Site | Praha 10 | |
| Italy | Research Site | Bari | |
| Italy | Research Site | Bergamo | |
| Italy | Research Site | Chieti Scalo | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Padova | |
| Italy | Research Site | Pisa | |
| Italy | Research Site | San Giovanni Rotondo | |
| Poland | Research Site | Bielsko-Biala | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Lódz | |
| Poland | Research Site | Mragowo | |
| Poland | Research Site | Ostrowiec Swietokrzyski | |
| Poland | Research Site | Tczew | |
| Poland | Research Site | Wroclaw | |
| Spain | Research Site | A Coruña | |
| Spain | Research Site | Alicante | |
| Spain | Research Site | Ferrol | |
| Spain | Research Site | La Laguna (Tenerife) | |
| Spain | Research Site | Lérida | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Málaga | |
| Spain | Research Site | Pozuelo de Alarcon | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Stockholm | |
| United States | Research Site | Brownsburg | Indiana |
| United States | Research Site | Burbank | California |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Chesterfield | Missouri |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chula Vista | California |
| United States | Research Site | Concord | California |
| United States | Research Site | Flint | Michigan |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntington Beach | California |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jackson | Michigan |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Los Gatos | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami Springs | Florida |
| United States | Research Site | Monroe | Louisiana |
| United States | Research Site | Newport Beach | California |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Salinas | California |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Bulgaria, Canada, Czechia, Italy, Poland, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24. | Baseline, Week 24 | |
| Secondary | Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24. | To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24. | Baseline, Week 24 | |
| Secondary | Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24. | To compare the mean change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24. | Baseline, Week 24 | |
| Secondary | Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24. | To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The "number analyzed" represents the number with change from baseline available at Week 24. | Baseline, Week 24 |
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