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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01820104

Enrollment

Registered

2013-03-28

Start date

2013-03-31

Completion date

2013-05-31

Last updated

2013-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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).

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).

Interventions

DRUGlansoprazole, 30 mg per day for 6 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Glucose Tolerance	0, 15, 30, 60, 90, 120, 180 min. after glucose administration

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026