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Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes (REPAIR-T1D)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Alex Rabinovitch, Sanford Health.
Recruitment status was:  Active, not recruiting
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Alex Rabinovitch, Sanford Health Identifier:
First received: June 3, 2010
Last updated: September 19, 2013
Last verified: September 2013
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.

Condition Intervention Phase
Type 1 Diabetes Drug: Sitagliptin and Lansoprazole Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Alex Rabinovitch, Sanford Health:

Primary Outcome Measures:
  • 2 hour C-peptide AUC in response to MMTT [ Time Frame: month 12 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 54
Study Start Date: August 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin and Lansoprazole Drug: Sitagliptin and Lansoprazole

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
Other Names:
  • Januvia
  • Prevacid
Placebo Comparator: Sugar pill Drug: Placebo
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.
Other Names:
  • Januvia
  • Prevacid


Ages Eligible for Study:   11 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01155284

United States, California
Rady Children's Hospital
San Diego, California, United States, 92123-4282
United States, Minnesota
Children's - St. Paul
St. Paul, Minnesota, United States, 55102
United States, South Dakota
Sanford Research/USD
Sioux Falls, South Dakota, United States, 57104
Sponsors and Collaborators
Sanford Health
Juvenile Diabetes Research Foundation
Principal Investigator: Alex Rabinovitch, MD Sanford Research/USD
Study Director: Diane L Hahn, LPN Sanford Research/USD
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alex Rabinovitch, Principal Investigator, Sanford Health Identifier: NCT01155284     History of Changes
Other Study ID Numbers: REPAIR-T1D
Study First Received: June 3, 2010
Last Updated: September 19, 2013

Keywords provided by Alex Rabinovitch, Sanford Health:
Beta Cell Regeneration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors processed this record on August 23, 2017