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Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660907
First received: April 15, 2008
Last updated: September 24, 2013
Last verified: September 2013

April 15, 2008
September 24, 2013
March 2008
December 2009   (final data collection date for primary outcome measure)
Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.
To examine whether the absolute change from baseline in HbA1c level with dapagliflozin plus metformin is non-inferior to glipizide plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on metformin therapy alone [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00660907 on ClinicalTrials.gov Archive Site
  • Adjusted Mean Change in Body Weight [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.
  • Proportion of Participants With at Least One Episode of Hypoglycemia [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.
  • Proportion of Participants With Body Weight Reduction of at Least 5% [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.
  • To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin [ Time Frame: after 52 weeks treatment ] [ Designated as safety issue: Yes ]
  • To show that dapagliflozin plus metformin treatment leads to fewer patients with hypoglycaemic events compared to glipizide plus metformin [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients
A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: dapagliflozin
    Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
  • Drug: glipizide
    Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
    Other Name: Glucotrol
  • Drug: metformin hydrochloride
    Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
    Other Name: Glucophage
  • Experimental: 1
    dapagliflozin plus metformin
    Interventions:
    • Drug: dapagliflozin
    • Drug: metformin hydrochloride
  • Active Comparator: 2
    glipizide plus metformin
    Interventions:
    • Drug: glipizide
    • Drug: metformin hydrochloride
Nauck M, del Prato S, Meier JJ, Durán-García S, Rohwedder K, Elze M, Parikh SJ. [Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S6-15. doi: 10.1055/s-0032-1305283. Epub 2013 Mar 25. German.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
814
January 2013
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 Diabetes
  • Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
  • HbA1c >6.5% and </=10%

Exclusion Criteria:

  • Type 1 Diabetes
  • Insulin therapy within one year of enrolment
  • Renal (kidney) failure or dysfunction
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   France,   Germany,   Italy,   Mexico,   Netherlands,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT00660907
D1690C00004
No
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Principal Investigator: Michael A. Nauck, Prof. Dr. med. Diabeteszentrum Bad Lauterberg, Germany
AstraZeneca
September 2013

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