NCT01541735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 21, 2014

Completed
Last Updated

February 21, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

February 20, 2012

Results QC Date

July 27, 2013

Last Update Submit

January 7, 2014

Conditions

Type 2 Diabetes

Keywords

DiabetesInsulinPantoprazole

Outcome Measures

Primary Outcomes (3)

  • First Phase of Insulin Secretion

    The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.

    Change from Baseline at 45 days. (plus or minus 3 days)

  • Second Phase of Insulin Secretion

    Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)

    Baseline and 45 day

  • Total Insulin Secretion

    The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion

    Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)

Secondary Outcomes (1)

  • Glycated Hemoglobin A1C

    Change from Baseline in glycated hemoglobin A1C at 45 day.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo of calcined magnesia, capsules

Drug: placebo

Pantoprazole

EXPERIMENTAL

The pantoprazole will be administered in 40mg capsules

Drug: Pantoprazole

Interventions

PantoprazoleDRUG

The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.

Also known as: Pantozol
Pantoprazole
placeboDRUG

Placebo 40 mg dose.

Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano del Seguro Social. Hospital de Especialidades.

Guadalajara, Jalisco, 44380, Mexico

Location

Related Publications (1)

  • Gonzalez-Ortiz M, Martinez-Abundis E, Mercado-Sesma AR, Alvarez-Carrillo R. Effect of pantoprazole on insulin secretion in drug-naive patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Apr;108(1):e11-3. doi: 10.1016/j.diabres.2015.01.039. Epub 2015 Feb 7.

    PMID: 25704601DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

The intervention time was short to evaluate a total change in the primary outcome variables

Results Point of Contact

Title
PhD. Manuel González Ortiz
Organization
Instituto Mexicano del Seguro Social
uiec@prodigy.net.mx
33 36176000

Study Officials

  • Manuel Gonzalez, PhD

    Instituto Mexicano del Seguro Social. Centro Medico Nacional de Occidente. Unidad de Investigación Médica en Epidemiologia Clínica

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2012

First Posted

March 1, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

February 21, 2014

Results First Posted

February 21, 2014

Record last verified: 2014-01

Locations

ME(1)