Clinical trial NCT00984867: Dapagliflozin DPPIV Inhibitor add-on Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin DPP IV inhibitor add on study
Inadequate control
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-09-25
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adjusted Mean Change in HbA1c Levels
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Adjusted Mean Change in Body Weight
timeFrame: Baseline to Week 24
measure: Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%
timeFrame: Baseline to Week 24
measure: Adjusted Mean Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to Week 24
measure: Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg
timeFrame: Baseline to Week 8
measure: Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise
timeFrame: Baseline to Week 24
measure: Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Ozark
country: United States
facility: Research Site
state: Alabama
city: Anaheim
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Greenbrae
country: United States
facility: Research Site
state: California
city: Laguna Hills
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: West Hills
country: United States
facility: Research Site
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Deland
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Longwood
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Port Orange
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Stone Mountain
country: United States
facility: Research Site
state: Georgia
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Lake Charles
country: United States
facility: Research Site
state: Louisiana
city: Edina
country: United States
facility: Research Site
state: Minnesota
city: St Louis
country: United States
facility: Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Pahrump
country: United States
facility: Research Site
state: Nevada
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Medord
country: United States
facility: Research Site
state: Oregon
city: Lancaster
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Research Site
state: South Carolina
city: Simpsonville
country: United States
facility: Research Site
state: South Carolina
city: Bristol
country: United States
facility: Research Site
state: Tennessee
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: North Richland Hills
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Burke
country: United States
facility: Research Site
state: Virginia
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Lakewood
country: United States
facility: Research Site
state: Washington
city: Berazategui
country: Argentina
facility: Research Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Lanus
country: Argentina
facility: Research Site
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Moron
country: Argentina
facility: Research Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Research Site
state: Caba
city: Caba
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Salta
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Bad Nauheim
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Meissen
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
state: DF
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Ciechocinek
country: Poland
facility: Research Site
city: Czechowice-dziedzice
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Gniewkowo
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Krotoszyn
country: Poland
facility: Research Site
city: Leczyca
country: Poland
facility: Research Site
city: Mragowo
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
state: Lancs
city: Burbage
country: United Kingdom
facility: Research Site
state: Leicester
city: Sunbury on Thames
country: United Kingdom
facility: Research Site
state: Middlesex
city: Wansford
country: United Kingdom
facility: Research Site
state: Peterborough
city: Ecclesfield
country: United Kingdom
facility: Research Site
state: Sheffield
city: Addlestone
country: United Kingdom
facility: Research Site
state: Surrey
city: Bath
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Thomas Jefferson University, Philadelphia
name: Serge Jabbour, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.2337/dc13-0467. Epub 2013 Oct 21.