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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 MMTT

Hgb 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

Page last updated: August 23, 2015

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