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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: August 10, 2016
Last verified: August 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 
Overall Participants Analyzed 
[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  (5.04)   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 Hemoglobin A1C (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 (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])   [ Time Frame: Baseline (Week 0) and at Week 24 ]

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

4.  Secondary:   Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])   [ Time Frame: At Week 24 ]

5.  Secondary:   Adjusted Mean Change From Baseline in Body Weight at Week 24   [ 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: August 10, 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