Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
64 participants
INTERVENTIONAL
2013-06-30
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Metformin
Metformin will be added to therapy for the first threre months.
Pioglitazone
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin, pioglitazone will be added.
Sitagliptin
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.
Interventions
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Metformin
Metformin will be added to therapy for the first threre months.
Pioglitazone
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin, pioglitazone will be added.
Sitagliptin
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* naive to therapy
* glycated hemoglobin \> 6.5 and \< 9.0 %
Exclusion Criteria
* recent cardiovascular diseases
* previous pancreatitis
* history of cancer
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
University of Pavia
OTHER
Responsible Party
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Giuseppe Derosa
MD, PhD
Principal Investigators
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Giuseppe Derosa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Policlinico San Matteo Foundation
Locations
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IRCCS Policlinico S. Matteo Foundation
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20120021548
Identifier Type: -
Identifier Source: org_study_id
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