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Endocrine
Comparison of a Needle-free Injection Method (T-jet™) With a Needle-syringe Injection Method for the Delivery of Tev-Tropin® in Pediatric Subjects With Human Growth Hormone Deficiency PDF Print E-mail

The purpose of this study is to obtain psychological response and user preference information on the use of the T jet™ device versus the traditional subcutaneous injection administration of Tev Tropin®.

This study will compare subject-reported injection anxiety immediately before the administration of each dose of Tev-Tropin® between a needle-syringe injection method and a needle-free injection method (T-jet™)
 
Diabetes Study - TrialNet PDF Print E-mail
  • The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes.
  • The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 3 to 4 percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes.

 

 
 
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents PDF Print E-mail
  • Patients ages 10-16 years old
  • The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetic agents(with diet and exercise) or who are being treated with Met, SU, or a combination of Met and SU (with or without diet and exercise).
 
Easypod United States User Trial PDF Print E-mail
  • This study will help to determine whether an injection log on a recombinant human growth hormone (rhGH) delivery device improves subjects' adherence with injection schedules. Adherence will be compared between a group of subjects who are aware of the injection log on the easypodTM rhGH delivery device and a group of subjects who are not aware of the easypodTM injection log. It is the study hypothesis that subject non-adherence rate is different for those who are aware of the injection log capability versus those who are unaware of the injection log capability. Subject perception will also be evaluated by comparing the ease and convenience of use and subject preference for the easypodTM compared to two other rhGH pen injection devices.

 
 
Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature PDF Print E-mail
  • To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

 
 


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