Triple Therapy in Type 2 Diabetic Patients
Effects on Glycemic Variability and Glyco-metabolic Control of Metformin, Pioglitazone and Sitagliptin in Type 2 Diabetic Patients
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes-mellitus
Started Jun 2013
Typical duration for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 30, 2013
CompletedFirst Posted
Study publicly available on registry
July 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 10, 2013
July 1, 2013
1 year
June 30, 2013
July 3, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Glycemic variability
Glycemic variability will be assessed at the baseline, and every three months, using a continuous glucose monitoring system.
9 months
Secondary Outcomes (1)
Glyco-metabolic control
9 months
Other Outcomes (1)
Insulin-resistance parameters
9 months
Study Arms (1)
Type 2 diabetic patients
EXPERIMENTALType 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.
Interventions
Metformin will be added to therapy for the first threre months.
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin, pioglitazone will be added.
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.
Eligibility Criteria
You may qualify if:
- type 2 diabetic patients
- naive to therapy
- glycated hemoglobin \> 6.5 and \< 9.0 %
You may not qualify if:
- hepatic and renal diseases
- recent cardiovascular diseases
- previous pancreatitis
- history of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Policlinico S. Matteo Foundation
Pavia, 27100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Derosa, MD, PhD
IRCCS Policlinico San Matteo Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 30, 2013
First Posted
July 10, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2016
Last Updated
July 10, 2013
Record last verified: 2013-07