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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01820104
First Posted: March 28, 2013
Last Update Posted: May 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xijing Hospital
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820104


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

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01820104     History of Changes
Other Study ID Numbers: 20130301
First Submitted: March 17, 2013
First Posted: March 28, 2013
Last Update Posted: May 3, 2013
Last Verified: May 2013

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