TrialWatch

Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients with Type 2 Diabetes

ClinicalTrials.gov Identifier: NCT00821977

This trial involves assessing the effects of vildagliptin, also known as Galvus, in people with type 2 diabetes. Vildagliptin is a member of the DPP-4 inhibitor class of drugs, along with Januvia (also called sitaglitpin) and recently approved Onglyza (also called saxagliptin). DPP-4 inhibitors are once-daily oral medications for type 2 diabetes that do not induce hypoglycemia (dangerously low blood sugar) or weight gain; however, these drugs only modestly lower blood glucose if not taken with other oral agents. Vildagliptin has been approved in Europe and been available for physicians to prescribe since 2007. This study will evaluate the effects of vildaglitpin only, not in combination with other drugs for the treatment of type 2 diabetes, after 24 weeks. In order to enroll in this study, individuals must be at least 18 years of age, be diagnosed with type 2 diabetes for at least two months, and not have been on any previous medications to treat type 2 diabetes. If you are a pregnant or lactating female, you will be excluded from the study. This study will be conducted in several sites across 34 states of the US. For more information on this trial and the nearest participating clinic, contact Novartis’ clinical trial center at (862) 778-8300.

Safety and Efficacy of Once-Daily KRP-104 in Type 2 Diabetic Patients That Cannot Control their Diabetes on Metformin Alone (Synergy 104)

ClinicalTrials.gov Identifier: NCT00995345

Similar to the previously described study, this trial will evaluate the effects of another DPP-4 inhibitor, KRP-104. Unlike the previous compound, vildagliptin, KRP-104 has not been approved in Europe. This study is recruiting individuals with type 2 diabetes, ages 18-75, either taking no medications for their diabetes or on metformin therapy. If taking metformin, only those taking metformin by itself or in combination with one other drug (not including DPP-4 inhibitors [Januvia or Onglyza], GLP-1 therapies [Byetta], insulin, Actos, or Avandia) will be considered for enrollment into the study. Individuals successfully recruited into the study will be randomly assigned to receive either placebo or one of four experimental doses of KRP-104. Given the detailed and specific exclusion criteria, we suggest visiting the trials’s website by clicking on the link above or calling the recruitment center at (866) 872-2349 for any additional questions or concerns.

Active Comparator Study of Generex Oral-LynTM Spray and Injected Human Insulin

ClinicalTrials.gov Identifier: NCT00668850

This study is enrolling individuals with type 1 diabetes to study whether a novel oral insulin spray, the Oral-lyn RapidMist System (manufactured by Generex), is as safe and effective as regular human insulin over a period of 26 weeks. After agreeing to participate, people will be randomly selected to receive either regular human insulin 30 minutes before meals or Oral-lyn spray administered immediately before and after meals. In order to be considered for the study, patients must have had type 1 diabetes for at least one year and currently be on insulin injections totaling 0.7 to 1.7 insulin units for every pound of body weight (for example, a 150 lb individual’s total daily insulin requirement must fall between 20 and 54 insulin units; for a 200 lb individual, total daily insulin requirement must fall between 27 and 73 insulin units). Those with active asthma, unstable retinopathy, or hypoglycemia unawareness will be excluded from this study. This study will be conducted worldwide, with 11 sites across different states in the US, including California, Florida, Indiana, Maryland, Michigan, Missouri, New York, Ohio, and Texas. For more information on this study, contact Kirill Soldatov at Kirill.Soldatov@psi-cro.com.