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Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01606007
First received: May 23, 2012
Last updated: May 30, 2016
Last verified: May 2016
Results First Received: December 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Saxagliptin
Drug: Metformin XR
Drug: Dapagliflozin
Drug: Placebo matching with Dapagliflozin
Drug: Placebo matching with Saxagliptin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Of 1282 participants enrolled subjects, 534 eligible subjects entered the randomized, double-blind treatment period.

Of 534 randomized and treated subjects, 490 subjects completed the study.


Reporting Groups
  Description
Arm 1: Saxagliptin+Metformin XR+Placebo Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
Arm 2: Dapagliflozin+Metformin XR+Placebo Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148

Participant Flow:   Overall Study
    Arm 1: Saxagliptin+Metformin XR+Placebo     Arm 2: Dapagliflozin+Metformin XR+Placebo     Arm 3: Saxagliptin+Dapagliflozin+Metformin XR  
STARTED     176     179     179  
COMPLETED     161     160     169  
NOT COMPLETED     15     19     10  
Reason 'Other' in the protocol                 0                 1                 1  
Pregnancy                 0                 1                 1  
Withdrawal by Subject                 8                 6                 1  
Adverse Event                 0                 1                 1  
discontinue study treatment                 0                 2                 1  
Lost to Follow-up                 6                 8                 5  
Poor/Non-compliance                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1: Saxagliptin+Metformin XR+Placebo Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
Arm 2: Dapagliflozin+Metformin XR+Placebo Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
Total Total of all reporting groups

Baseline Measures
    Arm 1: Saxagliptin+Metformin XR+Placebo     Arm 2: Dapagliflozin+Metformin XR+Placebo     Arm 3: Saxagliptin+Dapagliflozin+Metformin XR     Total  
Number of Participants  
[units: participants]
  176     179     179     534  
Age, Customized  
[units: participants]
       
<65 years     148     158     160     466  
>=65 years     28     21     19     68  
Gender  
[units: participants]
       
Female     82     90     94     266  
Male     94     89     85     268  
Race/Ethnicity, Customized  
[units: participants]
       
White     121     131     120     372  
Black african/american     22     16     22     60  
Asian     11     10     12     33  
Other     22     22     25     69  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean (Standard Deviation)
  31.8  (5.142)     31.46  (5.321)     31.76  (4.787)     31.67  (5.080)  
T2DM duration  
[units: years]
Mean (Standard Deviation)
  8.2  (5.52)     7.4  (5.39)     7.1  (5.03)     7.6  (5.33)  
HbA1c  
[units: %]
Mean (Standard Deviation)
  9.03  (1.05)     8.87  (1.16)     8.92  (1.18)     8.94  (1.13)  



  Outcome Measures
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1.  Primary:   Adjusted Mean Change From Baseline in HbA1c at Week 24   [ Time Frame: Baseline (Week 0) and at Week 24 ]

2.  Secondary:   Adjusted Mean Change From Baseline in 2-hour Post-prandial Glucose During a Liquid Meal Test (2-h MTT)   [ Time Frame: Baseline (Week 0) and at Week 24 ]

3.  Secondary:   Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG)   [ Time Frame: Baseline (Week 0) and at Week 24 ]

4.  Secondary:   Adjusted Percentage of Subjects Achieving Glycemic Response Defined as Glycosylated Hemoglobin (HbA1c) < 7%   [ Time Frame: At Week 24 ]

5.  Secondary:   Adjusted Mean Change From Baseline in Body Weight at Week 24 With the Addition of Saxagliptin and Dapagliflozin to Metformin vs. the Addition of Placebo and Saxagliptin to Metformin   [ Time Frame: Baseline (Week 0) and at Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Boaz Hirshberg
Organization: AstraZeneca Pharmaceuticals
e-mail: ClinicalTrialTransparency@astrazeneca.com


Publications of Results:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01606007     History of Changes
Other Study ID Numbers: CV181-169
2012-000679-18 ( EudraCT Number )
Study First Received: May 23, 2012
Results First Received: December 19, 2014
Last Updated: May 30, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks
Germany: Federal Institute for Drugs and Medical Devices
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Italy: Ethics Committee
Italy: The Italian Medicines Agency
India: Drugs Controller General of India
India: Institutional Review Board