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

Combination Therapy With Sitagliptin (DPP 4 Inhibitor) and Lansoprazole (PPI) Inhibitor) to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes

Sanford Research/USD proposes to study the combination therapy of oral administration of sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells still present in patients with recent-onset diabetes and possibly regenerating their beta cells, while safely down-regulating the autoimmune response directed against the beta cells.

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.