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Referrals for T2DM Patients Who Are Not Well-Controlled on Metformin Monotherapy 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 who are not well-controlled on metformin monotherapy. 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 for pediatric patients (10 - 17 years of age, inclusive) with T2DM who are inadequately controlled on metformin monotherapy. Sitagliptin - combined with metformin - will be compared to metformin monotherapy over a 20-week treatment period. 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 insulin for at least 6 months  
  • A1C > 7.0% and ≤ 10.0% on current metformin regimen (> 1500 mg/day for  > 12 weeks) 
If you have a pediatric patient whose T2DM is not adequately controlled on metformin, 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/NCT01472367?term=paediatric+sitagliptin+trial%2C+merck&rank=2   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)
 
Name of Principal Investigator: Dr Janet Hong
Name of Institution: Hospital Putrajaya
Phone Contact: 03-83124237 or 03-83124363 
 
Name of Principal Investigator: Dr Lim Poi Giok
Name of Institution: Paediatric Institute, Hospital Kuala Lumpur  
Phone Contact: 03-26155555 ext. 6939 or ext. 6873 (Norizan)
 
MREC has approved the above study. NMRR ID: NMRR-11-881-9925


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