This trial is active, not recruiting.

Condition type 1 diabetes
Treatments sitagliptin and lansoprazole, placebo
Phase phase 2
Sponsor Sanford Health
Collaborator Juvenile Diabetes Research Foundation
Start date August 2010
End date May 2014
Trial size 54 participants
Trial identifier NCT01155284, REPAIR-T1D


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
sitagliptin and lansoprazole Januvia
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
(Placebo Comparator)
placebo Januvia
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.

Primary Outcomes

2 hour C-peptide AUC in response to MMTT
time frame: month 12

Secondary Outcomes

2 hour C-peptide AUC in response to MMTT
time frame: months 6, 18, and 24
Hgb A1C levels
time frame: month 3, 6,9,12,18, and 24
Insulin use in units per kilogram body weight per day
time frame: month 3, 6, 9, 12, 18, and 24
Safety (adverse events frequency, severity)
time frame: up to month 24

Eligibility Criteria

Male or female participants from 11 years up to 45 years old.

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.

Additional Information

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
Principal investigator Alex Rabinovitch, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Sanford Health.