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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01155284
First Posted: July 1, 2010
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Kurt Griffin, Sanford Health
  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
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 Kurt Griffin, Sanford Health:

Primary Outcome Measures:
  • 2 Hour C-peptide AUC in Response to MMTT [ Time Frame: Month 12 ]
    Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.


Secondary Outcome Measures:
  • 2 Hour C-peptide AUC in Response to MMTT [ Time Frame: Month 6 ]
    Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90, and 120 minutes post-meal.


Enrollment: 70
Study Start Date: August 2010
Study Completion Date: March 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin and Lansoprazole
Sitagliptin 50mg co-administered with Lansoprazole 30mg. Subjects age 11-17 years at Visit 2 will take 1 capsule of each once daily Subjects age 18-45 years at Visit 2 will take 2 capsules of each once daily
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: Placebo
Sitagliptin Placebo and Lansoprazole placebo capsules will be administered. Subjects age 11-17 years at Visit 2 will take 1 placebo capsule of each once daily Subjects age 18-45 years at Visit 2 will take 2 placebo capsules of each once daily
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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155284


Locations
United States, California
Rady Children's Hospital
San Diego, California, United States, 92123-4282
United States, Minnesota
Children's - St. Paul
Saint 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

Publications:
Responsible Party: Kurt Griffin, Principal Investigator, Sanford Health
ClinicalTrials.gov Identifier: NCT01155284     History of Changes
Other Study ID Numbers: REPAIR-T1D
First Submitted: June 3, 2010
First Posted: July 1, 2010
Results First Submitted: December 18, 2014
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017
Last Verified: August 2017

Keywords provided by Kurt Griffin, Sanford Health:
diabetes
HGB A1C
Beta Cell Regeneration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Sitagliptin Phosphate
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Lansoprazole
Dexlansoprazole
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
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