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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: April 12, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c from baseline to week 24 [ Time Frame: up to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in total body weight from baseline to week 24 [ Time Frame: up to week 24 ] [ Designated as safety issue: No ]
  • Change in HbA1c in patients with baseline HbA1c ≥8% from baseline to week 24 [ Time Frame: up to week 24 ] [ Designated as safety issue: No ]
  • Change in FPG from baseline to week 24 [ Time Frame: up to week 24 ] [ Designated as safety issue: No ]
  • Change in seated Systolic Blood Pressure (SBP) from baseline to week 8 in subjects with baseline seated SBP ≥130 mmHg [ Time Frame: up to week 8 ] [ Designated as safety issue: No ]
  • Change in 2-hour post liquid meal glucose from baseline to week 24 [ Time Frame: up to week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as a reduction in HbA1c of ≥0.7% from baseline to week 24 [ Time Frame: up to week 24 ] [ Designated as safety issue: No ]

Enrollment: 452
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
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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00984867     History of Changes
Other Study ID Numbers: D1690C00010
Study First Received: September 23, 2009
Last Updated: April 12, 2012
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013