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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01820104
First received: March 17, 2013
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Healthy
Drug: lansoprazole, 30 mg per day for 6 days
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Glucose Tolerance [ Time Frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma insulin and C-peptide concentrations during oral glucose tolerance test [ Time Frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Oral glucose tolerance test (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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820104

Locations
China, Shaanxi
Department of pharmacy, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Sponsors and Collaborators
Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01820104     History of Changes
Other Study ID Numbers: 20130301
Study First Received: March 17, 2013
Last Updated: May 1, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Lansoprazole
Dexlansoprazole
Sitagliptin
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014