Clinical trial NCT01155284: Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Official title: Combination Therapy With Sitagliptin (DPP 4 Inhibitor) and Lansoprazole (PPI) Inhibitor) to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: diabetes
HGB A1C
Beta Cell Regeneration
Lead sponsor: Sanford Health
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2010-07-01
Enrollment: 70
Sex: ALL
Minimum age (years): 11
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: 2 Hour C-peptide AUC in Response to MMTT
timeFrame: Month 12
Secondary outcomes:
measure: 2 Hour C-peptide AUC in Response to MMTT
timeFrame: Month 6
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Saint Paul
country: United States
facility: Children's - St. Paul
state: Minnesota
city: Sioux Falls
country: United States
facility: Sanford Research/USD
state: South Dakota
Study officials:
affiliation: Sanford Research/USD
name: Alex Rabinovitch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanford Research/USD
name: Diane L Hahn, LPN
role: STUDY_DIRECTOR
References:
citation: Griffin KJ, Thompson PA, Gottschalk M, Kyllo JH, Rabinovitch A. Combination therapy with sitagliptin and lansoprazole in patients with recent-onset type 1 diabetes (REPAIR-T1D): 12-month results of a multicentre, randomised, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):710-8. doi: 10.1016/S2213-8587(14)70115-9. Epub 2014 Jul 2.