Diabetes Mellitus Clinical Trial
Official title:
A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin
| Verified date | December 2018 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.
| Status | Completed |
| Enrollment | 695 |
| Est. completion date | December 28, 2017 |
| Est. primary completion date | April 26, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility |
Inclusion criteria - Has a diagnosis of T2DM. - Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2. - Treated with a stable dose of metformin =1500 mg/day for at least 2 months prior to Screening. Exclusion criteria - FPG =280 mg/dL (15.6 mmol/L). - Serum calcitonin concentration =40 pg/mL (=40 ng/L) at Visit 1 (Screening) - Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator. - Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded. - Known active proliferative retinopathy. - History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations =500 mg/dL (=5.65 mmol/L) at Visit 1 - History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis. - History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded. |
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Research Site | Baja | |
| Hungary | Research Site | Balatonfüred | |
| Hungary | Research Site | Budaörs | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Eger | |
| Hungary | Research Site | Godollo | |
| Hungary | Research Site | Gödöllo | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Kecskemét | |
| Hungary | Research Site | Komárom | |
| Hungary | Research Site | Létavértes | |
| Hungary | Research Site | Nyíregyháza | |
| Hungary | Research Site | Pécs | |
| Hungary | Research Site | Szeged | |
| Hungary | Research Site | Szekszárd | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lódz | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Oswiecim | |
| Poland | Research Site | Parczew | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Zgierz | |
| Romania | Research Site | Baia Mare | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Galati | |
| Romania | Research Site | Oradea | |
| Romania | Research Site | Oradea | |
| Romania | Research Site | Oradea | |
| Romania | Research Site | Ploiesti | |
| Romania | Research Site | Timi?oara | |
| Slovakia | Research Site | Banska Bystrica | |
| Slovakia | Research Site | Bardejov | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Dolny Kubin | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Levice | |
| Slovakia | Research Site | Levice | |
| Slovakia | Research Site | Lucenec | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Pezinok | |
| Slovakia | Research Site | Sturovo | |
| Slovakia | Research Site | TrebiĊĦov | |
| South Africa | Research Site | Bloemfontein | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Johannesburg | |
| South Africa | Research Site | Kempton Park | |
| South Africa | Research Site | Middelburg | |
| South Africa | Research Site | Parow | |
| South Africa | Research Site | Port Elizabeth | |
| South Africa | Research Site | Pretoria | |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Avon | Indiana |
| United States | Research Site | Bellevue | Nebraska |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boynton Beach | Florida |
| United States | Research Site | Burke | Virginia |
| United States | Research Site | Burlington | North Carolina |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chula Vista | California |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Clinton | Utah |
| United States | Research Site | Coral Gables | Florida |
| United States | Research Site | Dakota Dunes | South Dakota |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | El Cajon | California |
| United States | Research Site | Evansville | Indiana |
| United States | Research Site | Fort Lauderdale | Florida |
| United States | Research Site | Franklin | Indiana |
| United States | Research Site | Fresno | California |
| United States | Research Site | Glendale | Arizona |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Greer | South Carolina |
| United States | Research Site | Haddon Heights | New Jersey |
| United States | Research Site | Hazelwood | Missouri |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | La Mesa | California |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mission Hills | California |
| United States | Research Site | Monroe | Louisiana |
| United States | Research Site | Montclair | California |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | Morehead City | North Carolina |
| United States | Research Site | Muncie | Indiana |
| United States | Research Site | Newton | Kansas |
| United States | Research Site | North Miami Beach | Florida |
| United States | Research Site | Oceanside | California |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Pearland | Texas |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Summerville | South Carolina |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tempe | Arizona |
| United States | Research Site | Tomball | Texas |
| United States | Research Site | Tuscumbia | Alabama |
| United States | Research Site | Tustin | California |
| United States | Research Site | Van Nuys | California |
| United States | Research Site | Vandalia | Ohio |
| United States | Research Site | Williston | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Hungary, Poland, Romania, Slovakia, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in HbA1c From Baseline to Week 28 | To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. | Baseline to Week 28 | |
| Secondary | Change in Body Weight From Baseline to Week 28 | To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. | Baseline to Week 28 | |
| Secondary | Change in Fasting Plasma Glucose From Baseline to Week 28 | To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. | Baseline to Week 28 | |
| Secondary | Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test | To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. | Baseline to Week 28 | |
| Secondary | Percentage of Patients Achieving Weight Loss =5.0% at Week 28 | To compare the percentage of patients achieving weight loss =5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. | Baseline to Week 28 | |
| Secondary | Change in Fasting Plasma Glucose From Baseline to Week 2 | To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. | Baseline to Week 2 | |
| Secondary | Percentage of Patients Achieving HbA1c <7% at Week 28 | To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. | Baseline to Week 28 | |
| Secondary | Change in Systolic Blood Pressure From Baseline to Week 28 | To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. | Baseline to Week 28 |
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