Type 2 Diabetes Mellitus
Conditions
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.
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.
Interventions
DRUGMetformin
Metformin will be added to therapy for the first threre months.
DRUGPioglitazone
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin, pioglitazone will be added.
DRUGSitagliptin
In patients not well controlled (glycated hemoglobin \>6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
University of Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variability | 9 months | Glycemic variability will be assessed at the baseline, and every three months, using a continuous glucose monitoring system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glyco-metabolic control | 9 months | Glyco-metabolic control will be assessed evaluating glycated hemoglobin, fasting plasma glucose and post-prandial glucose. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Insulin-resistance parameters | 9 months | Insulin-resistance parameters will be assessed using HOMA-index (HOMA-IR and HOMA-β). |
Countries
Italy
Contacts
Primary ContactGiuseppe Derosa, MD, PhD
Backup ContactPamela Maffioli, MD
Outcome results
None listed