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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Dexlansoprazole; Lansoprazole; Sitagliptin Phosphate

Criteria

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