Dapagliflozin DPPIV Inhibitor add-on Study

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00984867
First received: September 23, 2009
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Dapagliflozin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adjusted Mean Change in Body Weight [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 833
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Dapagliflozin 10 mg tablet
Drug: Dapagliflozin
10 mg tablet, oral, once daily, 48 weeks
Placebo Comparator: 2
Matching placebo tablet
Drug: Placebo
Matching placebo tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984867

  Show 88 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Principal Investigator: Serge Jabbour, MD Thomas Jefferson University, Philadelphia
  More Information

Additional Information:
Publications:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00984867     History of Changes
Other Study ID Numbers: D1690C00010
Study First Received: September 23, 2009
Results First Received: January 21, 2013
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Dapagliflozin DPP IV inhibitor add on study
Inadequate control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014