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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: lansoprazole, 30 mg per day for 6 days

• Registration Number: NCT01820104
• Lead Sponsor: Xijing Hospital

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).

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-17
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-28
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-01
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Combination of lansoprazole and sitagliptin	lansoprazole, 30 mg per day for 6 days	oral sitagliptin 100 mg on day 6 after administration of lansoprazole (30 mg per day) for 6 days

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of pharmacy, Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China