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

Study Overview
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Brief Summary
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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.

Official Title
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Combination Therapy With Sitagliptin (DPP 4 Inhibitor) and Lansoprazole (PPI) Inhibitor) to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Sitagliptin and Lansoprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin and Lansoprazole<br>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<br>* 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<br>* Other names: Prevacid;|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>* Other names: Prevacid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, HGB A1C, Beta Cell Regeneration