Overview
Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Status:
Completed
Completed
Trial end date:
2015-03-01
2015-03-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Sanford HealthCollaborator:
Juvenile Diabetes Research FoundationTreatments:
Dexlansoprazole
Lansoprazole
Sitagliptin Phosphate
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.