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

March 17, 2013
May 1, 2013
March 2013
May 2013   (final data collection date for primary outcome measure)
Glucose Tolerance [ Time Frame: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration ] [ Designated as safety issue: No ]
Glucose Tolerance [ Time Frame: 0, 15, 30, 60, 90, 120 min. after glucose administration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01820104 on ClinicalTrials.gov Archive Site
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 ]
Plasma insulin and C-peptide concentrations during oral glucose tolerance test [ Time Frame: 0, 15, 30, 60, 90, 120 min. after glucose administration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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).

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).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Healthy
Drug: lansoprazole, 30 mg per day for 6 days
Other Name: Oral glucose tolerance test (OGTT)
  • 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
    Intervention: Drug: lansoprazole, 30 mg per day for 6 days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01820104
20130301
No
Xijing Hospital
Xijing Hospital
Not Provided
Not Provided
Xijing Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP