Type 1 Diabetes Clinical Trial
— REPAIR-T1DOfficial title:
Combination Therapy With Sitagliptin (DPP 4 Inhibitor) and Lansoprazole (PPI) Inhibitor) to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Verified date | August 2017 |
Source | Sanford Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Sanford Health | Juvenile Diabetes Research Foundation |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02750527 -
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
|
||
Completed |
NCT02897557 -
Insulet Artificial Pancreas Early Feasibility Study
|
N/A |