CClinicalTrials.gg
CompletedNCT01820104Updated May 3, 2013

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

A Phase 1 interventional study of lansoprazole, 30 mg per day for 6 days in Healthy, sponsored by Xijing Hospital. Completed at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-03.

Sponsored by Xijing Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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).

Read the 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).

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • General good health condition
  • Male subject, between 18 and 50 years

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
16 participants (actual)

Study arms

  • 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

Interventions

  • Druglansoprazole, 30 mg per day for 6 days

    Also known as: Oral glucose tolerance test (OGTT)

06

What researchers measure

Primary outcomes

  1. Glucose Tolerance

    Time frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration

Secondary outcomes

  1. Plasma insulin and C-peptide concentrations during oral glucose tolerance test

    Time frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration

07

Study locations

1 site
  • Department of pharmacy, Xijing Hospital, Fourth Military Medical University
    Xi'an, Shaanxi, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01820104
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Mar 28, 2013
Start date
Mar 2013
Primary completion
May 2013
Completion
May 2013
Last update
May 3, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion