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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin and Lansoprazole | Experimental | 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 |
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| Placebo | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin and Lansoprazole | Drug | Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) or matching placebo
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| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Rabinovitch, MD | Sanford Research/USD | Principal Investigator |
| Diane L Hahn, LPN | Sanford Research/USD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123-4282 | United States | ||
| Children's - St. Paul |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24997559 | Result | 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. |
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At a screening visit, participants underwent procedures to establish that all inclusion criteria were met and none of the exclusion criteria were met. All participants and if applicable, guardians provided written informed consent/assent at screening.
Four centers screened 79 participants were screened between August 2010 and May 2012. Participants aged 11-36 years, diagnosed with type 1 diabetes within the past 6 months were recruited. 9 participants were not randomized as 7 were deemed ineligible and 2 were lost to follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin and Lansoprazole | Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | 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. |
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| Saint Paul |
| Minnesota |
| 55102 |
| United States |
| Sanford Research/USD | Sioux Falls | South Dakota | 57104 | United States |
Placebo: Matching placebo was given daily for 12 months. |
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| NOT COMPLETED |
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70 participants were randomized. After randomization, 2 participants withdrew (one was from treatment group and one from placebo group) before taking any drugs, leaving 46 participants in the active treatment group and 22 in the placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin and Lansoprazole | Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months. |
| BG001 | Placebo | Matching placebo will be given daily for 12 months. Participants were then followed for an additional 12 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Days Post diagnosis | Mean | Standard Deviation | Days |
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| GAD antibody positive | Number | participants |
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| HLA DR Allele - Neither DR3 nor DR4 | Number | participants |
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| HLA DR Allele - DR3 only | Number | participants |
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| HLA DR4 Allele only | Number | participants |
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| HLA DR Allele - Both DR3 and DR4 | Number | participants |
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| Insulin use (units/kg per day) | Mean | Standard Deviation | units/kg per day |
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| 2 -hour C-peptide Area Under Curve Result in Response to Standardized Mixed Meal Tolerance Test | C-peptide reflects how much insulin pancreatic beta cells are making. The MMTT measures how much insulin can be made. Blood samples for C-peptide were collected at baseline, 15, 30, 60, 90 and 120 minutes post-meal. Results are presented as the time weighted average concentration. To maintain consistency with prior reports, this has been labeled as "AUC," although it may be more accurate to describe this as an AUC mean (pmol/L), [true AUC (pmol*min/L) / 120 minutes]. Larger numbers are better, reflecting preservation of insulin production. | Mean | Standard Deviation | pmol/L |
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| Glucose (mmol/L) | time weighed mean during mixed meal test | Mean | Standard Deviation | mmol/L |
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| HbA1c (%) | Mean | Standard Deviation | % |
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| IDA-HbA1c (%) | Mean | Standard Deviation | % |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Of the 70 subjects randomized, 58 completed treatment and analysis. | Posted | Median | 95% Confidence Interval | pmol/L | Month 12 |
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| 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. | Of the 70 subjects randomized, 58 completed treatment and analysis. | Posted | Median | 95% Confidence Interval | pmol/L | Month 6 |
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Adverse event data was collected from the August 2010 to May 2013
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin and Lansoprazole | Sitagliptin and Lansoprazole: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) taken for 12 months.
| 2 | 46 | 44 | 46 | ||
| EG001 | Placebo | 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. | 1 | 22 | 21 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Papillary Carcinoma of the Thyroid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) |
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| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) |
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| Appendicitis | Gastrointestinal disorders | CTCAE (4.0) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) |
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| Infections and Infestations-Other | Infections and infestations | CTCAE (4.0) |
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| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) |
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| Headache | Nervous system disorders | CTCAE (4.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt J. Griffin, PhD, MD, Director of Clinical Trials | Sanford Research | 6053126000 | kurt.griffin@sanfordhealth.org |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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