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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: lansoprazole, 30 mg per day for 6 days

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Department of pharmacy, Xijing Hospital, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; oral sitagliptin 100 mg on day 6 after administration of placebo (30 mg per day) for 6 days
Experimental: Combination of lansoprazole and sitagliptin; 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; Other Names: Oral glucose tolerance test (OGTT)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 17, 2013
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Estimate): May 3, 2013
• Last Update Submitted That Met QC Criteria: May 1, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 20130301