Pantoprazole on Insulin Secretion in Diabetes

Overview[ - collapse ][ - ]

Purpose The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in drug-naïve patients with type 2 diabetes.
ConditionType 2 Diabetes
InterventionDrug: Pantoprazole
Drug: placebo
PhasePhase 2/Phase 3
SponsorCoordinación de Investigación en Salud, Mexico
Responsible PartyCoordinación de Investigación en Salud, Mexico
ClinicalTrials.gov IdentifierNCT01541735
First ReceivedFebruary 20, 2012
Last UpdatedJanuary 7, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateFebruary 20, 2012
Last Updated DateJanuary 7, 2014
Start DateJanuary 2012
Estimated Primary Completion DateMay 2013
Current Primary Outcome Measures
  • First Phase of Insulin Secretion [Time Frame: Change from Baseline at 45 days. (plus or minus 3 days)] [Designated as safety issue: No]The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.
  • Second Phase of Insulin Secretion [Time Frame: Baseline and 45 day] [Designated as safety issue: No]Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)
  • Total Insulin Secretion [Time Frame: Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)] [Designated as safety issue: No]The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion
Current Secondary Outcome MeasuresGlycated Hemoglobin A1C [Time Frame: Change from Baseline in glycated hemoglobin A1C at 45 day.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitlePantoprazole on Insulin Secretion in Diabetes
Official TitleEffect of Pantoprazole on Insulin Secretion in Patients With Type 2 Diabetes
Brief Summary
The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in
drug-naïve patients with type 2 diabetes.
Detailed Description
Type 2 diabetes mellitus (T2DM) has become a major health problem worldwide with a high
prevalence and related mortality, and a high rate of disability in the economically active.
In Mexico the prevalence was 14.4% reported one of the highest in Latin America and
estimated a cost of $ 778 million allocated for this disease in 2010, i.e., the tenth place
worldwide. Within its pathophysiology are alterations in the secretion and insulin action,
qualitatively and quantitatively, which implies a challenge for long-term metabolic control
with the pharmacological arsenal available today. Since the function of pancreatic β cell
decreases as a function of time and lack of control is essential metabolic find drugs that
can preserve pancreatic cell mass and even promote neogenesis, with the aim of restoring the
physiological secretion of insulin have been lost in the early stages of type 2 diabetes to
achieve optimal glycemic control sustained over time to avoid complications and reduce the
costs associated with the disease.

Have been evaluated in animal models with promising results Proton Pumps Inhibitors (PPI)
for the restoration of glucose and the preservation of pancreatic cell function, including
promoting its growth through increased levels of gastrin, which appears to act as a growth
factor. However, at present no such mechanisms have been evaluated in humans, it would be
interesting to assess the effect of administration of a PPI such as pantoprazole is, on the
phases of insulin secretion in patients with T2DM recent diagnosis.

Material and Methods: Randomized, double-blind, placebo controlled clinical trial.
Population: 14 drug-naive adults patients with T2DM and obesity.
Hyperglycemic-hyperinsulinemic clamp to assess the phases of insulin secretion. Intervention
for 45 days: pantoprazole 40mg or placebo.
Study TypeInterventional
Study PhasePhase 2/Phase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: Pantoprazole
The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.
Other Names:
PantozolDrug: placebo
Placebo 40 mg dose.
Other Names:
placebo
Study Arm (s)
  • Placebo Comparator: Placebo
    Placebo of calcined magnesia, capsules
  • Experimental: Pantoprazole
    The pantoprazole will be administered in 40mg capsules

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment14
Estimated Completion DateMay 2013
Estimated Primary Completion DateMarch 2013
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.
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesMexico

Administrative Information[ + expand ][ + ]

NCT Number NCT01541735
Other Study ID NumbersIBP1301-93
Has Data Monitoring CommitteeYes
Information Provided ByCoordinación de Investigación en Salud, Mexico
Study SponsorCoordinación de Investigación en Salud, Mexico
CollaboratorsNot Provided
Investigators Principal Investigator: Manuel Gonzalez, PhD Instituto Mexicano del Seguro Social. Centro Medico Nacional de Occidente. Unidad de Investigación Médica en Epidemiologia Clínica
Verification DateJanuary 2014

Locations[ + expand ][ + ]

Instituto Mexicano del Seguro Social. Hospital de Especialidades.
Guadalajara, Jalisco, Mexico, 44380