Type 2 Diabetes Clinical Trial
Official title:
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin
| Verified date | June 2014 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.
| Status | Completed |
| Enrollment | 833 |
| Est. completion date | September 2011 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with type 2 diabetes - Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these - Patients will be screened by a blood test and only those who need additional therapy can be enrolled Exclusion Criteria: - Patients with type 1 diabetes - Patients with very poorly controlled diabetes - Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Berazategui | Buenos Aires |
| Argentina | Research Site | Buenos Aires | Caba |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | La Plata | Buenos Aires |
| Argentina | Research Site | Lanus | Buenos Aires |
| Argentina | Research Site | Mar Del Plata | Buenos Aires |
| Argentina | Research Site | Moron | Buenos Aires |
| Argentina | Research Site | Salta | |
| Argentina | Research Site | Santa Fe | |
| Germany | Research Site | Bad Nauheim | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Meissen | |
| Germany | Research Site | Munster | |
| Germany | Research Site | Pirna | |
| Germany | Research Site | Wangen | |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Mexico | DF |
| Poland | Research Site | Ciechocinek | |
| Poland | Research Site | Czechowice-dziedzice | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Gniewkowo | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Krotoszyn | |
| Poland | Research Site | Leczyca | |
| Poland | Research Site | Mragowo | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Sopot | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Zabrze | |
| United Kingdom | Research Site | Addlestone | Surrey |
| United Kingdom | Research Site | Bath | |
| United Kingdom | Research Site | Belfast | |
| United Kingdom | Research Site | Blackpool | |
| United Kingdom | Research Site | Bolton | Lancs |
| United Kingdom | Research Site | Burbage | Leicester |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Ecclesfield | Sheffield |
| United Kingdom | Research Site | Harrow | |
| United Kingdom | Research Site | Sunbury on Thames | Middlesex |
| United Kingdom | Research Site | Wansford | Peterborough |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Boca Raton | Florida |
| United States | Research Site | Bristol | Tennessee |
| United States | Research Site | Burke | Virginia |
| United States | Research Site | Chula Vista | California |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Corpus Christi | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Deland | Florida |
| United States | Research Site | Edina | Minnesota |
| United States | Research Site | Greenbrae | California |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Laguna Hills | California |
| United States | Research Site | Lake Charles | Louisiana |
| United States | Research Site | Lakewood | Washington |
| United States | Research Site | Lancaster | Pennsylvania |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Longwood | Florida |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Medord | Oregon |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Research Site | Myrtle Beach | South Carolina |
| United States | Research Site | North Richland Hills | Texas |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Ozark | Alabama |
| United States | Research Site | Pahrump | Nevada |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Port Orange | Florida |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Riverside | California |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Simpsonville | South Carolina |
| United States | Research Site | St Louis | Missouri |
| United States | Research Site | Staten Island | New York |
| United States | Research Site | Stone Mountain | Georgia |
| United States | Research Site | West Hills | California |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Bristol-Myers Squibb |
United States, Argentina, Germany, Mexico, Poland, United Kingdom,
Jabbour SA, Hardy E, Sugg J, Parikh S; Study 10 Group. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740-50. doi — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adjusted Mean Change in HbA1c Levels | To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin. | Baseline to Week 24 | No |
| Secondary | Adjusted Mean Change in Body Weight | To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24. | Baseline to Week 24 | No |
| Secondary | Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c =8% | To compare the change in HbA1c in participants with baseline HbA1c =8% achieved with dapagliflozin versus placebo from baseline to week 24. | Baseline to Week 24 | No |
| Secondary | Adjusted Mean Change in Fasting Plasma Glucose (FPG) | To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24. | Baseline to Week 24 | No |
| Secondary | Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg | To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8. | Baseline to Week 8 | No |
| Secondary | Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise | To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24. | Baseline to Week 24 | No |
| Secondary | Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of =0.7% Compared to Baseline | To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of =0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value. | Baseline to Week 24 | No |
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