NCT02345239

Brief Summary

The purpose of this study is to demonstrate the immediate impact of pantoprazole on 24-H glycemic control and on post-prandial glucose excursion in patients with type 2 diabetes.If our data support the previous animal, observational and clinical studies results, PPIs could become a new anti-diabetic agent with a good and safe profile for type 2 diabetes

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_3 diabetes-mellitus

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

January 19, 2015

Last Update Submit

January 22, 2015

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Mean 24-hour glucose level

    7 days

  • Mean post-prandial glucose excursion

    7 days

Secondary Outcomes (2)

  • Mean Mean 24-hour glucose level

    day 6 and 7

  • Postprandial glucose excursion

    day 6 and 7

Study Arms (1)

Pantoprazole

EXPERIMENTAL

Pantoprazole

Drug: Pantoprazole

Interventions

PantoprazoleDRUG

proton pump inhibitor

Pantoprazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009 Apr;58(4):773-95. doi: 10.2337/db09-9028. No abstract available.

    PMID: 19336687BACKGROUND

  • Allen JM, Adrian TE, Webster J, Howe A, Bloom SR. Effect of single dose of omeprazole on the gastrointestinal peptide response to food. Hepatogastroenterology. 1984 Feb;31(1):44-6.

    PMID: 6365714BACKGROUND

  • Bellomo Damato A, Stefanelli G, Laviola L, Giorgino R, Giorgino F. Nateglinide provides tighter glycaemic control than glyburide in patients with Type 2 diabetes with prevalent postprandial hyperglycaemia. Diabet Med. 2011 May;28(5):560-6. doi: 10.1111/j.1464-5491.2010.03219.x.

    PMID: 21204958BACKGROUND

  • Bodvarsdottir TB, Hove KD, Gotfredsen CF, Pridal L, Vaag A, Karlsen AE, Petersen JS. Treatment with a proton pump inhibitor improves glycaemic control in Psammomys obesus, a model of type 2 diabetes. Diabetologia. 2010 Oct;53(10):2220-3. doi: 10.1007/s00125-010-1825-6. Epub 2010 Jun 30.

    PMID: 20585936BACKGROUND

  • Boj-Carceller D. Proton pump inhibitors: impact on glucose metabolism. Endocrine. 2013 Feb;43(1):22-32. doi: 10.1007/s12020-012-9755-3. Epub 2012 Aug 12.

    PMID: 22886351BACKGROUND

  • Boj-Carceller D, Bocos-Terraz P, Moreno-Vernis M, Sanz-Paris A, Trincado-Aznar P, Albero-Gamboa R. Are proton pump inhibitors a new antidiabetic drug? A cross sectional study. World J Diabetes. 2011 Dec 15;2(12):217-20. doi: 10.4239/wjd.v2.i12.217.

    PMID: 22174957BACKGROUND

  • Brand SJ, Tagerud S, Lambert P, Magil SG, Tatarkiewicz K, Doiron K, Yan Y. Pharmacological treatment of chronic diabetes by stimulating pancreatic beta-cell regeneration with systemic co-administration of EGF and gastrin. Pharmacol Toxicol. 2002 Dec;91(6):414-20. doi: 10.1034/j.1600-0773.2002.910621.x.

    PMID: 12688387BACKGROUND

  • Brunner G, Athmann C, Schneider A. Long-term, open-label trial: safety and efficacy of continuous maintenance treatment with pantoprazole for up to 15 years in severe acid-peptic disease. Aliment Pharmacol Ther. 2012 Jul;36(1):37-47. doi: 10.1111/j.1365-2036.2012.05106.x. Epub 2012 Apr 24.

    PMID: 22531114BACKGROUND

  • Crouch MA, Mefford IN, Wade EU. Proton pump inhibitor therapy associated with lower glycosylated hemoglobin levels in type 2 diabetes. J Am Board Fam Med. 2012 Jan-Feb;25(1):50-4. doi: 10.3122/jabfm.2012.01.100161.

    PMID: 22218624BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Waheed Rehman, FRCPC,DABIM

    McGill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Waheed Rehman, FRCPC,DABIM

CONTACT

514-655-5755waheed.rehman@mail.mcgill.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician/Resident

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 26, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Last Updated

January 26, 2015

Record last verified: 2015-01