A Phase 4 interventional study of Metformin and Pioglitazone in Type 2 Diabetes Mellitus, sponsored by University of Pavia. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-10.
Sponsored by University of Pavia · Phase 4, Interventional, and Treatment
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.
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:
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 64 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Pavia is the lead sponsor of 141 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
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 · Drug: Pioglitazone · Drug: Sitagliptin
Metformin will be added to therapy for the first threre months.
Also known as: 500 mg three times a day
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin, pioglitazone will be added.
Also known as: 15 mg twice a day
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.
Also known as: 100 mg once a day
Glycemic variability
Glycemic variability will be assessed at the baseline, and every three months, using a continuous glucose monitoring system.
Time frame: 9 months
Glyco-metabolic control
Glyco-metabolic control will be assessed evaluating glycated hemoglobin, fasting plasma glucose and post-prandial glucose.
Time frame: 9 months
Insulin-resistance parameters
Insulin-resistance parameters will be assessed using HOMA-index (HOMA-IR and HOMA-β).
Time frame: 9 months
This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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University of Pavia