Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin
| Verified date | December 2018 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.
| Status | Completed |
| Enrollment | 464 |
| Est. completion date | August 29, 2016 |
| Est. primary completion date | August 29, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility |
Inclusion criteria: - Has a diagnosis of Type 2 Diabetes Mellitus (T2DM) - Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening). - Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1 (Screening) - Treated with basal insulin glargine at a dose of =20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with: 1. a stable dose of metformin (=1500 mg/day) for at least 8 weeks prior to Visit 1 2. a stable dose of metformin (=1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit Exclusion criteria: - Serum calcitonin concentration =40 pg/mL (=40 ng/L) at Visit 1 (Screening) - History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations =500 mg/dL (=5.65 mmol/L) at Visit 1 - Positive serological test for hepatitis B or hepatitis C |
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Research Site | Baja | |
| Hungary | Research Site | Balatonfured | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Eger | |
| Hungary | Research Site | Gödöllo | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Komárom | |
| Hungary | Research Site | Létavértes | |
| Hungary | Research Site | Pécs | |
| Hungary | Research Site | Satoraljaujhely | |
| Hungary | Research Site | Szeged | |
| Hungary | Research Site | Szekszárd | |
| Poland | Research Site | Lódz | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Oswiecim | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Zamosc | |
| 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 | Ploiesti | |
| Romania | Research Site | Tg Mures | |
| Romania | Research Site | Timi?oara | |
| Slovakia | Research Site | Bardejov | |
| 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 | Nitra | |
| Slovakia | Research Site | Presov | |
| Slovakia | Research Site | Sturovo | |
| South Africa | Research Site | Bloemfontein | |
| South Africa | Research Site | Kempton Park | |
| South Africa | Research Site | Krugersdorp | |
| South Africa | Research Site | Paarl | |
| South Africa | Research Site | Pretoria | |
| South Africa | Research Site | Pretoria | |
| South Africa | Research Site | Somerset West | |
| South Africa | Research Site | Worcester | |
| United States | Research Site | Austin | Texas |
| 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 | Brooksville | Florida |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chiefland | Florida |
| United States | Research Site | Chino | California |
| United States | Research Site | Chula Vista | California |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Clinton | Utah |
| United States | Research Site | Columbus | Georgia |
| 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 | Dayton | Ohio |
| 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 | 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 | Houston | Texas |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Johnson City | Tennessee |
| United States | Research Site | Kingsport | Tennessee |
| 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 | 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 | Mooresville | North Carolina |
| United States | Research Site | Morehead City | North Carolina |
| United States | Research Site | Morganton | North Carolina |
| United States | Research Site | Muscle Shoals | Alabama |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | Newton | Kansas |
| United States | Research Site | North Miami Beach | Florida |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Port Orchard | Washington |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Tempe | Arizona |
| United States | Research Site | Tustin | California |
| United States | Research Site | West Hills | California |
| 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 in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea. | Baseline to Week 28 | |
| Secondary | Change in Body Weight From Baseline to Week 28 | To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. | Baseline to Week 28 | |
| Secondary | Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT) | To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. | Baseline to Week 28 | |
| Secondary | Percentage of Participants Achieving HbA1c <7.0% at Week 28 | To compare the percentage of participants achieving HbA1c <7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. | Baseline to Week 28 | |
| Secondary | Change From Baseline to Week 28 in Daily Insulin Dose | To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. | Baseline to Week 28 | |
| Secondary | Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks | To compare the percentage of participants achieving HbA1c <7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin. | Baseline to Week 28 | |
| Secondary | Change in Seated Systolic Blood Pressure From Baseline to Week 28 | To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. | Baseline to Week 28 |
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