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Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

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: NCT00673231
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : August 23, 2013
Last Update Posted : October 29, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

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 : 1240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes With Inadequate Glycaemic Control on Insulin
Study Start Date : April 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : January 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
2.5mg
 Drug: Dapagliflozin
tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

Drug: Dapagliflozin
tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
Experimental: 2
5mg
 Drug: Dapagliflozin
Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Experimental: 3
10mg
 Drug: Dapagliflozin
Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

Drug: Dapagliflozin
tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg
Placebo Comparator: 4 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 24 ]
    To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.


Secondary Outcome Measures :
  1. Adjusted Mean Change in Body Weight [ Time Frame: Baseline to Week 24 ]
    To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration.

  2. Adjusted Mean Change in Calculated Mean Daily Insulin Dose [ Time Frame: Baseline to Week 24 ]
    To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration.

  3. Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction [ Time Frame: Baseline to Week 24 ]
    To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment.

  4. Adjusted Mean Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 24 ]
    To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration.


Other Outcome Measures:
  1. Proportion of Participants With Lack of Glycemic Control [ Time Frame: Baseline to Week 24 ]
    Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes
  • Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs

Exclusion Criteria:

  • Type 1 Diabetes
  • Treatment with more than two additional oral antidiabetic drugs
  • Moderate and severe renal (kidney) failure or dysfunction
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): NCT00673231


Locations
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Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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Principal Investigator: John Wilding, MD Clinical Sciences CentreUniversity Hospital AintreeLongmoor LaneLiverpool, UK
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00673231    
Other Study ID Numbers: D1690C00006
First Posted: May 7, 2008    Key Record Dates
Results First Posted: August 23, 2013
Last Update Posted: October 29, 2013
Last Verified: September 2013
Keywords provided by AstraZeneca:
Dapagliflozin
efficacy
safety
 add on to insulin
Oral AntiDiabetic
Type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
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