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

NCT ID: NCT01155284

Last Updated: 2017-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2015-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Sitagliptin and Lansoprazole

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Januvia; Prevacid; Januvia; Prevacid

Eligibility 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Sanford Health

OTHER

Sponsor Role: lead

Responsible Party

Kurt Griffin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alex Rabinovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Sanford Research/USD

Diane L Hahn, LPN

Role: STUDY_DIRECTOR

Sanford Research/USD

Locations

Rady Children's Hospital

San Diego, California, United States

Children's - St. Paul

Saint Paul, Minnesota, United States

Sanford Research/USD

Sioux Falls, South Dakota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24997559 (View on PubMed)

Other Identifiers

REPAIR-T1D

Identifier Type: -

Identifier Source: org_study_id