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

Type 1 Diabetes Clinical Trial

— REPAIR-T1D  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155284
• Other study ID #: REPAIR-T1D
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2010
• Last updated: August 18, 2017
• Start date: August 2010
• Est. completion date: March 2015

Study information

• Verified date: August 2017
• Source: Sanford Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Children's - St. Paul	Saint Paul	Minnesota
United States	Rady Children's Hospital	San Diego	California
United States	Sanford Research/USD	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Sanford Health	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

References & 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 tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 6