Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes

Launched by SANFORD HEALTH · Jun 30, 2010

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of type 1 diabetes, based on American Diabetes Association criteria, recently diagnosed (within the 6 months before Screening) and confirmed by the presence of at least 1 diabetes related autoantibody (either glutamic acid decarboxylase \[GAD\], insulinoma-associated protein \[IA 2\], or insulin, the latter measured within 10 days after starting insulin therapy).
• • Male or female aged between 11 and 45 years, inclusive.
• • Able to swallow study capsules.
• • Willing to comply with "intensive diabetes management" as directed by the investigator, with the goal of maintaining blood glucose as close to American Diabetes Association recommendations as possible.
• • Willing to comply with the schedule of study visits and protocol requirements.
• Exclusion Criteria:
• • Use of a GLP 1R agonist or DPP 4 inhibitor within 1 month before enrollment.
• • Use of a PPI within 1 month before enrollment.
• • Use of an oral hypoglycemic agent within 1 month before enrollment or use of thiazolidinediones within 3 months before enrollment (although thiazolidinediones may be used \<7days before enrollment).
• • Females of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
• • Females who are pregnant or breastfeeding at the time of enrollment.
• * Subjects with any of the following conditions:
• • Renal insufficiency, defined as estimated glomerular filtration rate (GFR) less than 50 mL/min at Screening, calculated using the Modification of Diet in Renal Disease (MDRD) equation.
• • History of a serious hypersensitivity reaction to sitagliptin or lansoprazole, such as anaphylaxis or angioedema.
• • Severe hepatic insufficiency.
• • History of pancreatitis or gallbladder disease
• • Any significant medical condition, which in the opinion of the investigator or medical monitor would interfere with study participation.