Pantoprazole on Insulin Secretion in Diabetes (IBP)

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: placebo; Drug: Pantoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01541735

IBP1301-93

Details and patient eligibility

About

The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in drug-naïve patients with type 2 diabetes.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo of calcined magnesia, capsules

Treatment:

Drug: placebo

Pantoprazole

Experimental group

Description:

The pantoprazole will be administered in 40mg capsules

Treatment:

Drug: Pantoprazole