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Triple Therapy in Type 2 Diabetic Patients

NCT01895569 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2013-07-10

No results posted yet for this study

Summary

The treatment of type 2 diabetes mellitus often requires the use of one or more hypoglycemic agents to reach the adequate glycemic control. The aim of the study is to evaluate the effects of a triple therapy with metformin, pioglitazone and sitagliptin on glycemic variability compared to metformin monotherapy, and compared to a combination of metformin and pioglitazone. To assess glycemic variability a continuous glucose monitoring system will be used.

Conditions

Interventions

DRUG

Metformin

Metformin will be added to therapy for the first threre months.

DRUG

Pioglitazone

In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin, pioglitazone will be added.

DRUG

Sitagliptin

In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    collaborator OTHER

  • University of Pavia

    lead OTHER

Principal Investigators

  • Giuseppe Derosa, MD, PhD · IRCCS Policlinico San Matteo Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-06-30
Completion
2016-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895569 on ClinicalTrials.gov