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

NCT01155284 | Completed Phase 2 Results DMC

• 1 other identifier: REPAIR-T1D
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

diabetes; HGB A1C; Beta Cell Regeneration

Outcome Measures

Primary Outcomes (1)

• 2 Hour C-peptide AUC in Response to MMTT

  Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.

  Month 12

Secondary Outcomes (1)

• 2 Hour C-peptide AUC in Response to MMTT

  Month 6

Study Arms (2)

Sitagliptin and Lansoprazole

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Sitagliptin and Lansoprazole DRUG

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

Also known as: Januvia, Prevacid

Sitagliptin and Lansoprazole

Placebo DRUG

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.

Also known as: Januvia, Prevacid

Placebo

Eligibility Criteria

• Age: 11 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanford Health: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (3)

Rady Children's Hospital

San Diego, California, 92123-4282, United States

Location

Children's - St. Paul

Saint Paul, Minnesota, 55102, United States

Location

Sanford Research/USD

Sioux Falls, South Dakota, 57104, United States

Location

Related Publications (1)

• Griffin KJ, Thompson PA, Gottschalk M, Kyllo JH, Rabinovitch A. Combination therapy with sitagliptin and lansoprazole in patients with recent-onset type 1 diabetes (REPAIR-T1D): 12-month results of a multicentre, randomised, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):710-8. doi: 10.1016/S2213-8587(14)70115-9. Epub 2014 Jul 2.

  PMID: 24997559 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Sitagliptin Phosphate; Lansoprazole

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Kurt J. Griffin, PhD, MD, Director of Clinical Trials
• Organization: Sanford Research

kurt.griffin@sanfordhealth.org

6053126000

Study Officials

• Alex Rabinovitch, MD

  Sanford Research/USD

  PRINCIPAL INVESTIGATOR

• Diane L Hahn, LPN

  Sanford Research/USD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: July 1, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: March 1, 2015
• Last Updated: September 18, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-08

Locations

US (3)