Skip to main content
OpenTrials
Completed

NCT Number: NCT01820104

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Department of pharmacy, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lansoprazole, 30 mg per day for 6 days

Drug

Other names: Oral glucose tolerance test (OGTT)

Primary outcomes

  1. Glucose Tolerance

    Time frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration

Secondary outcomes

  1. Plasma insulin and C-peptide concentrations during oral glucose tolerance test

    Time frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2013
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.