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

This study is ongoing, but not recruiting participants.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Sanford Health:

Primary Outcome Measures:
  • 2 hour C-peptide AUC in response to MMTT [ Time Frame: month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2 hour C-peptide AUC in response to MMTT [ Time Frame: months 6, 18, and 24 ] [ Designated as safety issue: No ]
  • Hgb A1C levels [ Time Frame: month 3, 6,9,12,18, and 24 ] [ Designated as safety issue: No ]
  • Insulin use in units per kilogram body weight per day [ Time Frame: month 3, 6, 9, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Safety (adverse events frequency, severity) [ Time Frame: up to month 24 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanford Health:
Beta Cell Regeneration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 21, 2014