Type 1 Diabetes Mellitus Clinical Trial
— DEPICT 2Official title:
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus - Study Two
| Verified date | February 2019 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.
| Status | Completed |
| Enrollment | 815 |
| Est. completion date | April 18, 2018 |
| Est. primary completion date | September 2, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of Type 1 Diabetes mellitus (T1DM) - Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L) - Insulin use for at least 12 months per patient reported or medical records - Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening - Subjects must be on a total insulin dose of = 0.3 U/kg/day for at least 3 months prior to screening - If on MDI insulin administration, subject must be on = 3x injections per day - Screening Visit: Central laboratory HbA1c = 7.7% and = 11.0% - Body mass index (BMI) = 18.5 kg/m2 Exclusion Criteria: - History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity - Taking any non-insulin antihyperglicemic agent within 1 month prior to screening - Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration - Taking metformin and/or thiazolidinediones within 2 months prior to screening - History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening - History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening - Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening - History of Addison's disease |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Corrientes | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Ramos Mejía | |
| Belgium | Research Site | Brussels (Uccle) | |
| Belgium | Research Site | Leuven | |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Cambridge | Ontario |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Sherbrooke | Quebec |
| Canada | Research Site | Smiths Falls | Ontario |
| Chile | Research Site | Santiago | |
| Chile | Research Site | Santiago | |
| Chile | Research Site | Temuco | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Falkensee | |
| Germany | Research Site | Freiburg im Breisgau | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Heidelberg | |
| Germany | Research Site | Oldenburg | |
| Germany | Research Site | Pohlheim | |
| Germany | Research Site | Saarlouis | |
| Germany | Research Site | Sulzbach-Rosenberg | |
| Germany | Research Site | Wangen | |
| Japan | Research Site | Aki-gun | |
| Japan | Research Site | Amagasaki-shi | |
| Japan | Research Site | Chitose-shi | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Fukuyama-shi | |
| Japan | Research Site | Higashiosaka-shi | |
| Japan | Research Site | Ibusuki-shi | |
| Japan | Research Site | Kagoshima-shi | |
| Japan | Research Site | Kamakura-shi | |
| Japan | Research Site | Kashiwara-shi | |
| Japan | Research Site | Kitakyushu-shi | |
| Japan | Research Site | Koriyama-shi | |
| Japan | Research Site | Kumamoto-shi | |
| Japan | Research Site | Kurume-shi | |
| Japan | Research Site | Miura-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Obihiro-shi | |
| Japan | Research Site | Oita-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Oyama-shi | |
| Japan | Research Site | Sapporo-shi | |
| Japan | Research Site | Shibuya-ku | |
| Japan | Research Site | Shinjuku-ku | |
| Japan | Research Site | Shizuoka-shi | |
| Japan | Research Site | Tsukuba-shi | |
| Japan | Research Site | Ushiku-shi | |
| Japan | Research Site | Uwajima-shi | |
| Japan | Research Site | Yokohama-shi | |
| Japan | Research Site | Yokohama-shi | |
| Netherlands | Research Site | Hoogeveen | |
| Netherlands | Research Site | Maastricht | |
| Netherlands | Research Site | Utrecht | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Warsaw | |
| Poland | Research Site | Wroclaw | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | St. Petersburg | |
| Russian Federation | Research Site | St.Petersburg | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Helsingborg | |
| Sweden | Research Site | Linkoping | |
| Sweden | Research Site | Uddevalla | |
| Switzerland | Research Site | Olten | |
| Switzerland | Research Site | St. Gallen | |
| Switzerland | Research Site | Zollikerberg | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Northampton | |
| United Kingdom | Research Site | Oldham | |
| United Kingdom | Research Site | Swansea | |
| United Kingdom | Research Site | Wakefield | |
| United States | Research Site | Albany | New York |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Amarillo | Texas |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Bennington | Vermont |
| United States | Research Site | Bradenton | Florida |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Concord | California |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Des Moines | Iowa |
| United States | Research Site | Edina | Minnesota |
| United States | Research Site | Edinburg | Texas |
| United States | Research Site | Federal Way | Washington |
| United States | Research Site | Flushing | New York |
| United States | Research Site | Fort Lauderdale | Florida |
| United States | Research Site | Fresno | California |
| United States | Research Site | Golden | Colorado |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jefferson City | Missouri |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Mesquite | Texas |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami Springs | Florida |
| United States | Research Site | Mineola | New York |
| United States | Research Site | New Hyde Park | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | Newark | Delaware |
| United States | Research Site | Orange | California |
| United States | Research Site | Overland Park | Kansas |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Reno | Nevada |
| United States | Research Site | Roswell | Georgia |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Mateo | California |
| United States | Research Site | San Ramon | California |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Bristol-Myers Squibb |
United States, Argentina, Belgium, Canada, Chile, Germany, Japan, Netherlands, Poland, Russian Federation, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in HbA1c at Week 24 | To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment | Baseline and 24 weeks | |
| Secondary | Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24 | To compare the percent change from baseline in total daily insulin dose with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment | Baseline and 24 weeks | |
| Secondary | Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24 | To compare the percentage change from baseline in body weight with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment | Baseline and 24 weeks | |
| Secondary | Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24 | To compare the change from baseline in mean value of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment | Baseline and 24 weeks | |
| Secondary | Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24 | To compare the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment | Baseline and 24 weeks | |
| Secondary | Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24 | To compare the change from baseline in the percent of 24-hour glucose readings obtained from CGM that falls within the target range of >70 mg/dL and <=180 mg/dL with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment | Baseline and 24 weeks | |
| Secondary | Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24 | To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the proportion of subjects achieving an HbA1c reduction from baseline to Week 24 visit >=0.5% without severe hypoglycemia events | Baseline and 24 weeks |
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