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Dapagliflozin DPPIV Inhibitor add-on Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Dapagliflozin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 833 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984867


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

Publications of Results:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00984867    
Other Study ID Numbers: D1690C00010
First Posted: September 25, 2009    Key Record Dates
Results First Posted: October 14, 2013
Last Update Posted: June 13, 2014
Last Verified: June 2014
Keywords provided by AstraZeneca:
Dapagliflozin DPP IV inhibitor add on study
Inadequate control
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs