Completed

Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males

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What is being tested

lansoprazole, 30 mg per day for 6 days

Drug
Who is being recruted

From 18 to 50 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorXijing Hospital
Last updated: May 3, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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).

NCT01820104
Principal SponsorXijing Hospital
Last updated: May 3, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
General good health condition
Male subject, between 18 and 50 years
11 exclusion criteria prevent from participating
Exhaustive ( > 3 units/day) alcohol consumption
Exhaustive ( > 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)
History of drug abuse
History of gastrointestinal disorders
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of pharmacy, Xijing Hospital, Fourth Military Medical University

Xi'an, ChinaOpen Department of pharmacy, Xijing Hospital, Fourth Military Medical University in Google Maps
CompletedOne Study Center