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

Phase 1CompletedNCT01820104

Xijing Hospital16 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

lansoprazole, 30 mg per day for 6 daysDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of pharmacy, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

Glucose Tolerance

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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