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Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes (REPAIR-T1D)

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sitagliptin and Lansoprazole

Placebo

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring diabetes, HGB A1C, Beta Cell Regeneration

Eligibility Criteria

11 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Rady Children's Hospital
Children's - St. Paul
Sanford Research/USD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sitagliptin and Lansoprazole

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01155284

First Posted

June 3, 2010

Last Updated

August 18, 2017

Sponsor

Sanford Health

Collaborators

Juvenile Diabetes Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01155284

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sanford Health

Collaborators

Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

diabetes, HGB A1C, Beta Cell Regeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitagliptin and Lansoprazole

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sitagliptin and Lansoprazole

Other Intervention Name(s)

Januvia, Prevacid

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

Januvia, Prevacid

Intervention Description

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.

Primary Outcome Measure Information:

Title

2 Hour C-peptide AUC in Response to MMTT

Description

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

Time Frame

Month 12

Secondary Outcome Measure Information:

Title

2 Hour C-peptide AUC in Response to MMTT

Description

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

Time Frame

Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alex Rabinovitch, MD

Organizational Affiliation

Sanford Research/USD

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Diane L Hahn, LPN

Organizational Affiliation

Sanford Research/USD

Official's Role

Study Director

Facility Information:

Facility Name

Rady Children's Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123-4282

Country

United States

Facility Name

Children's - St. Paul

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

Sanford Research/USD

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24997559

Citation

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.

Results Reference

result

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

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