Phase 3
N=14
Pantoprazole on Insulin Secretion in Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01541735 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: First Phase of Insulin Secretion — 13.8; 15.9 µU/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pantoprazole (Drug); placebo (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Coordinación de Investigación en Salud, Mexico
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First Phase of Insulin Secretion |
13.8; 15.9 | — |
| PRIMARY Second Phase of Insulin Secretion |
35.9; 38.4 | — |
| PRIMARY Total Insulin Secretion |
29.0; 31.5 | — |
| SECONDARY Glycated Hemoglobin A1C |
7.5; 7.8 | — |
Summary
The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in drug-naïve patients with type 2 diabetes.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Drug-Naive
- No complications
- HbA1c 7 to < 9%
- Fasting plasma glucose < 210mg/dl
- Body mass index 30.0 to 39.9 and body weight stable for at least 3 months before the study
- Non smokers
- Blood pressure < 130/80
Exclusion Criteria
- Diabetes complications
- Women pregnant or stage of lactation
- Hepatic, renal, autoimmune disease
- Take drugs with effects on insulin secretion
- Zollinger-Ellison disease
- Gastric or pancreatic tumor.
Data sourced from ClinicalTrials.gov (NCT01541735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.