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Referrals for Newly Diagnosed or T2DM Patients With Inadequate Glycemic Control for Phase III Clinical Trial

18 February 2013

Dear Colleague,

With the rise of type 2 diabetes (T2DM) amongst pediatric patients, it is imperative to expand safe and effective treatment options. We are  currently participating as investigators for a Phase III sitagliptin research study for pediatric patients with T2DM. As an investigator, we would like to ask for your help with patient referrals. 
 
About the Pediatric Type 2 Diabetes Research Study   
 
Sitagliptin, an investigational, oral medication, is being assessed  as an initial monotherapy for T2DM in pediatric patients (10 – 17 years of  age, inclusive) who have inadequate glycemic control. There will be an initial  placebo-controlled, treatment phase, after which all patients on placebo will  be blindly switched to either sitagliptin or metformin for the remainder of  the study. 
 
All investigational medications, monitoring, and study-related care  – including diet and exercise counseling and monitoring – will be provided at  no cost.
 
Key inclusion criteria for this research study include:  
  •  Patient age is 10 – 17 years old (inclusive)
  •  Patient diagnosed with T2DM based on ADA criteria 
     
  •  BMI >85th percentile 
     
  •  No oral diabetes treatment for at least the past 12 weeks  
  •  All newly diagnosed patients fulfill this criteria and do not need to wait 12  weeks
     
  • No treatment with insulin for at least the past 6 months  
  • A1C of > 7.0% and ≤  10.0%
If you have a pediatric T2DM patient with inadequate glycemic  control, we hope you would consider this research study opportunity for them,  and feel free to have their parent or guardian contact us (see contact details  below) to learn more. We believe this is a potential opportunity for advancing  glycemic control options for this patient population.
 
For more details about the study, the information can be found on website: www.clinicaltrials.gov.  
Please click on this link: http://www.clinicaltrials.gov/ct2/show/NCT01485614?term=paediatric+sitagliptin+trial%2C+merck&rank=1   to access the trial-specific information.
 
Our contact details are as below:
 
Name of Principal Investigator: Dr Muhammed Yazid  Jalaludin
Name of Institution: University Malaya Medical Centre  
Phone Contact: 03-79492622 (Sister Sim or Sister  Lim)
 
Name of Principal Investigator: Prof Dato’ Dr Mafauzy  Mohamed
Name of Institution: Hospital Universiti Sains  Malaysia
Phone Contact: 09-7676845 or 7676847 (Sister  Rubiah)


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