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Dapagliflozin DPPIV Inhibitor add-on Study

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ClinicalTrials.gov Identifier: NCT00984867
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : October 14, 2013
Last Update Posted : June 13, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

September 23, 2009
September 25, 2009
January 21, 2013
October 14, 2013
June 13, 2014
October 2009
March 2011   (Final data collection date for primary outcome measure)
Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 24 ]
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.
Change in HbA1c from baseline to week 24 [ Time Frame: 9 samples: at weeks 0;4;8;12;18;24;32;40;48 ]
Complete list of historical versions of study NCT00984867 on ClinicalTrials.gov Archive Site
  • Adjusted Mean Change in Body Weight [ Time Frame: Baseline to Week 24 ]
    To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.
  • Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8% [ Time Frame: Baseline to Week 24 ]
    To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.
  • Adjusted Mean Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 24 ]
    To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.
  • Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg [ Time Frame: Baseline to Week 8 ]
    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.
  • Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise [ Time Frame: Baseline to Week 24 ]
    To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.
  • Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline [ Time Frame: Baseline to Week 24 ]
    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.
  • Change in total body weight from baseline to week 24 [ Time Frame: 9 samples: at weeks 0;4;8;12;18;24;32;40;48 ]
  • Change in HbA1c in patients with baseline HbA1c ≥8% from baseline to week 24 [ Time Frame: 9 samples: at weeks 0;4;8;12;18;24;32;40;48 ]
  • Change in FPG from baseline to week 24 [ Time Frame: 9 samples: at weeks 0;4;8;12;18;24;32;40;48 ]
Not Provided
Not Provided
 
Dapagliflozin DPPIV Inhibitor add-on Study
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Dapagliflozin
    10 mg tablet, oral, once daily, 48 weeks
  • Drug: Placebo
    Matching placebo tablet
  • Active Comparator: 1
    Dapagliflozin 10 mg tablet
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: 2
    Matching placebo tablet
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
833
432
September 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Germany,   Mexico,   Poland,   United Kingdom,   United States
 
 
NCT00984867
D1690C00010
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Principal Investigator: Serge Jabbour, MD Thomas Jefferson University, Philadelphia
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP