Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Information source: Sanford Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: Sitagliptin and Lansoprazole (Drug); Placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Sanford Health Official(s) and/or principal investigator(s): Alex Rabinovitch, MD, Principal Investigator, Affiliation: Sanford Research/USD Diane L Hahn, LPN, Study Director, Affiliation: Sanford Research/USD
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 2 hour C-peptide AUC in response to MMTT
Secondary outcome: 2 hour C-peptide AUC in response to MMTTHgb A1C levels Insulin use in units per kilogram body weight per day Safety (adverse events frequency, severity)
Eligibility
Minimum age: 11 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Rady Children's Hospital, San Diego, California 92123-4282, United States
Children's - St. Paul, St. Paul, Minnesota 55102, United States
Sanford Research/USD, Sioux Falls, South Dakota 57104, United States
Additional Information
Starting date: August 2010
Last updated: September 19, 2013
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