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

NCT ID: NCT01820104

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-05-31

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Combination of lansoprazole and sitagliptin

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

Group Type: EXPERIMENTAL

lansoprazole, 30 mg per day for 6 days

Intervention Type: DRUG

Interventions

lansoprazole, 30 mg per day for 6 days

Intervention Type: DRUG

Other Intervention Names

Oral glucose tolerance test (OGTT)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of pharmacy, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

20130301

Identifier Type: -

Identifier Source: org_study_id