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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.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Alex Rabinovitch, Sanford Health
ClinicalTrials.gov Identifier:
NCT01155284
First received: June 3, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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: April 2014
Estimated Primary Completion Date: October 2013 (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

  Eligibility

Ages Eligible for Study:   11 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155284

Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01155284     History of Changes
Other Study ID Numbers: REPAIR-T1D
Study First Received: June 3, 2010
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanford Health:
diabetes
HGB A1C
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
Lansoprazole
Sitagliptin
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

ClinicalTrials.gov processed this record on May 23, 2013