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Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes (PROMPT)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01006590
First received: October 31, 2009
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
Results First Received: November 30, 2011  
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 Mellitus
Interventions: Drug: Saxagliptin
Drug: Metformin

  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
The study was conducted at hospital clinics and general practitioners. Patient recruitment started October 20, 2009 and was completed April 30, 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening, enrollment (2 weeks) and lead-in period (4 weeks). Main reason for not being randomised was due to renal function not meeting inclusion criteria. (Samples taken and analysed after enrollment into the study but prior to randomisation).

Reporting Groups
  Description
Saxagliptin Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
Metformin Uptitration Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day

Participant Flow:   Overall Study
    Saxagliptin     Metformin Uptitration  
STARTED     147 [1]   139 [1]
COMPLETED     119 [2]   107 [2]
NOT COMPLETED     28     32  
Adverse Event                 2                 3  
Death                 1                 1  
Lost to Follow-up                 1                 1  
Protocol Violation                 1                 0  
Withdrawal by Subject                 4                 2  
Study specific discontinuation criteria                 16                 23  
Not specified                 3                 2  
[1] Randomised and treated
[2] Completed 24 weeks of treatment



  Baseline Characteristics
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Reporting Groups
  Description
Saxagliptin Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
Metformin Uptitration Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
Total Total of all reporting groups

Baseline Measures
    Saxagliptin     Metformin Uptitration     Total  
Number of Participants  
[units: participants]
 		  147     139     286  
Age  
[units: Years]
Mean ± Standard Deviation 		  58.7  ± 11.31     58.6  ± 9.79     58.7  ± 10.58  
Gender  
[units: Participants]
 		     
Female     59     63     122  
Male     88     76     164  



  Outcome Measures
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1.  Primary:   Absolute Change From Baseline in HbA1c at Week 24   [ Time Frame: Baseline and 24 weeks ]
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Measure Type Primary
Measure Title Absolute Change From Baseline in HbA1c at Week 24
Measure Description No text entered.
Time Frame Baseline and 24 weeks  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
Saxagliptin Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
Metformin Uptitration Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day

Measured Values
    Saxagliptin     Metformin Uptitration  
Number of Participants Analyzed  
[units: participants]
 		  146     137  
Absolute Change From Baseline in HbA1c at Week 24  
[units: Percent (%)]
Mean ± Standard Error 		  -0.47  ± 0.06     -0.38  ± 0.06  


Statistical Analysis 1 for Absolute Change From Baseline in HbA1c at Week 24
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.26
Mean Difference (Net) [4] -0.10
Standard Error of the mean ± 0.09
95% Confidence Interval ( -0.26 to 0.07 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis H0: µt-µC=0, where μT denotes the mean absolute change in HbA1c from baseline to Week 24 in the group of patients treated with saxagliptin (test medication, T) and μC the mean absolute change in HbA1c from baseline to Week 24 in the group of patients with uptitration of metformin (comparator, C) A sample size of 120 randomized and treated patients per treatment group yielded 80% power under the assumption of a true treatment difference of 0.4% and a standard deviation of 1.1%
[2] Other relevant information, such as adjustments or degrees of freedom:
  With baseline value as covariate and treatment group as factor; comparison of LSmeans for treatment
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%   [ Time Frame: 24 Weeks ]
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3.  Secondary:   Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%   [ Time Frame: 24 Weeks ]
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4.  Secondary:   Change From Baseline to Week 24 in Fasting Plasma Glucose   [ Time Frame: Baseline and 24 weeks ]
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5.  Secondary:   Change From Baseline to Week 24 in Fasting Insulin   [ Time Frame: Baseline and 24 weeks ]
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6.  Secondary:   Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta   [ Time Frame: Baseline and 24 weeks ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01006590     History of Changes
Other Study ID Numbers: D1680L00003
Study First Received: October 31, 2009
Results First Received: November 30, 2011
Last Updated: January 16, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: CPP Comité de Protection des Personnes = Ethics Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices (Bfarm)
Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
Turkey: Regional Ethics Committee
Turkey: Ministry of Health
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines