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

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: lansoprazole, 30 mg per day for 6 days

Study type: Interventional

Funder types: Other

Identifiers

NCT01820104

20130301

Details and patient eligibility

About

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).

Full 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).

Enrollment: 16 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Combination of lansoprazole and sitagliptin

Experimental group

Description:

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

Treatment:

Drug: lansoprazole, 30 mg per day for 6 days