Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sitagliptin and Lansoprazole; Placebo
Intervention description: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) or matching placebo
Subjects age 11-17 years at Visit 2 will take 1 capsule once daily
Subjects age 18-45 years at Visit 2 will take 2 capsules once daily; Sitagliptin 50mg and Lansoprazole 30 mg or matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
Intervention MeSH terms: Sitagliptin Phosphate; Lansoprazole; Dexlansoprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 11 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: diabetes; HGB A1C; Beta Cell Regeneration

Summary:

      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.
    

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.