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Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males: a Randomised Crossover Study

Sponsor
Xijing Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01820104
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
2
Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole, DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).

Condition or Disease Intervention/Treatment Phase
  • Drug: lansoprazole, 30 mg per day for 6 days
 Phase 1

Detailed Description

Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. We sought to examine the effect of PPI (lansoprazole), DPP4 (sitagliptin), and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

oral sitagliptin 100 mg on day 6 after administration of placebo (30 mg per day) for 6 days
Experimental: Combination of lansoprazole and sitagliptin

oral sitagliptin 100 mg on day 6 after administration of lansoprazole (30 mg per day) for 6 days

Drug: lansoprazole, 30 mg per day for 6 days
Other Names:
  • Oral glucose tolerance test (OGTT)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glucose Tolerance [0, 15, 30, 60, 90, 120, 180 min. after glucose administration]

    Secondary Outcome Measures

    1. Plasma insulin and C-peptide concentrations during oral glucose tolerance test [0, 15, 30, 60, 90, 120, 180 min. after glucose administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • General good health condition

    • Male subject, between 18 and 50 years

    Exclusion Criteria

    • Overweight (Body Mass Index ≥30)

    • Metabolic disorders

    • History of gastrointestinal disorders

    • Regular (daily) intake of medication

    • Smoking more than 10 cigarettes/day

    • History of drug abuse

    • Exhaustive (> 3 units/day) alcohol consumption

    • Exhaustive (> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)

    • Recent (in the last 14 days) donation of blood

    • Recent (in the last 2 days) donation of blood plasma

    • Participation in another trial within 4 weeks before the start of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of pharmacy, Xijing Hospital, Fourth Military Medical University Xi'an Shaanxi China

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT01820104
    Other Study ID Numbers:
    • 20130301
    First Posted:
    Mar 28, 2013
    Last Update Posted:
    May 3, 2013
    Last Verified:
    May 1, 2013
    Additional relevant MeSH terms:
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of May 3, 2013