Triple Therapy in Type 2 Diabetic Patients

July 3, 2013 updated by: Giuseppe Derosa, University of Pavia

Effects on Glycemic Variability and Glyco-metabolic Control of Metformin, Pioglitazone and Sitagliptin in Type 2 Diabetic Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In an estimated temporal space of about 3 years, 64 not well controlled, type 2 diabetic patients will be recruited.

Patients will be instructed to take metformin 500 mg three times a day for the first three months, then pioglitazone 15 mg twice a day will be added for further three months, and finally sitagliptin 100 mg once a day will be added for the last three months. At the baseline, and every three months a continuous glucose monitoring system will be performed.

At any stage of the study, if the value of glycated hemoglobin reach the desired goal (<6.5%), participation in the study will be stopped and the patient will not be subjected to further adjustments of hypoglycemic therapy or additional continuous monitoring glucose.

After collection of written informed consent, the following data will be collected:

  • History: type of diabetes, comorbidities, current medication, duration of diabetes and complications, voluptuary habits such as tobacco smoke (both number of packets/year and n° packets/day), alcohol consumption, coffee consumption, physical activity.
  • Physical exam, general anthropometric parameters such as weight, height, circumference, body mass index, waist-hip ratio, and blood pressure.
  • Assessment of glycemic variability every three months using a continuous glucose monitoring system.
  • Collection of blood and urine samples to assess: glycated hemoglobin, fasting plasma glucose (FPG), post-prandial glucose (PPG), fasting plasma insulin (FPI), HOMA-index (HOMA-IR and HOMA-β), high sensitivity C-reactive protein (hs-CRP), total cholesterol, LDL-cholesterol, HDL-cholesterol, tryglicerides, lipoprotein (a) [Lp(a)], metalloproteinase-2 (MMP-2), metalloproteinase-9 (MMP-9), soluble adhesion molecules (sICAM-1, sVCAM-1), sE-selectin, adiponectin (ADN), complete urinalysis, 24-hour microalbuminuria.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • IRCCS Policlinico S. Matteo Foundation
        • Sub-Investigator:
          • Pamela Maffioli, MD
        • Principal Investigator:
          • Giuseppe Derosa, MD, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetic patients
  • naive to therapy
  • glycated hemoglobin > 6.5 and < 9.0 %

Exclusion Criteria:

  • hepatic and renal diseases
  • recent cardiovascular diseases
  • previous pancreatitis
  • history of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Type 2 diabetic patients
Type 2 diabetic patients, naive to treatment, and not well controlled by diet (glycate hemoglobin > 6.5%, and < 9.0%) will be instructed to take metformin, followed by metformin plus pioglitazone, and then metformin plus pioglitazone plus sitagliptin.
Drug: Metformin
Metformin will be added to therapy for the first threre months.
Other Names:
  • 500 mg three times a day
Drug: Pioglitazone
In patients not well controlled (glycated hemoglobin >6.5%) after three months of metformin, pioglitazone will be added.
Other Names:
  • 15 mg twice a day
Drug: Sitagliptin
In patients not well controlled (glycated hemoglobin >6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.
Other Names:
  • 100 mg once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic variability
Time Frame: 9 months
Glycemic variability will be assessed at the baseline, and every three months, using a continuous glucose monitoring system.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glyco-metabolic control
Time Frame: 9 months
Glyco-metabolic control will be assessed evaluating glycated hemoglobin, fasting plasma glucose and post-prandial glucose.
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin-resistance parameters
Time Frame: 9 months
Insulin-resistance parameters will be assessed using HOMA-index (HOMA-IR and HOMA-β).
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Collaborators

IRCCS Policlinico S. Matteo

Investigators

  • Principal Investigator: Giuseppe Derosa, MD, PhD, irccs policlinico san matteo foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 30, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120021548

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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