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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT01155284

Run by

Sanford Health

People needed

70

Starts

2010-08-01

Expected to finish

2015-03-01

Last updated by the study team

2017-09-18

Who can join

Age: 11 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rady Children's Hospital — San Diego, California, United States
• Children's - St. Paul — Saint Paul, Minnesota, United States
• Sanford Research/USD — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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