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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: lansoprazole, 30 mg per day for 6 days


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>oral sitagliptin 100 mg on day 6 after administration of placebo (30 mg per day) for 6 days | |
| Experimental: Combination of lansoprazole and sitagliptin<br>oral sitagliptin 100 mg on day 6 after administration of lansoprazole (30 mg per day) for 6 days | Drug: lansoprazole, 30 mg per day for 6 days<br> <br> * Other names: Oral glucose tolerance test (OGTT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Tolerance |  | 0, 15, 30, 60, 90, 120, 180 min. after glucose administration | 

Secondary Outcome Measures

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