Triple Therapy in Type 2 Diabetic Patients | RxWiki

Triple Therapy in Type 2 Diabetic Patients

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Metformin Drug: Pioglitazone Drug: Sitagliptin
Phase	Phase 4
Sponsor	University of Pavia
Responsible Party	University of Pavia
ClinicalTrials.gov Identifier	NCT01895569
First Received	June 30, 2013
Last Updated	July 3, 2013
Last verified	July 2013

Tracking Information[ + expand ][ + ]

First Received Date	June 30, 2013
Last Updated Date	July 3, 2013
Start Date	June 2013
Estimated Primary Completion Date	June 2016
Current Primary Outcome Measures	Glycemic variability [Time Frame: 9 months] [Designated as safety issue: Yes]Glycemic variability will be assessed at the baseline, and every three months, using a continuous glucose monitoring system.
Current Secondary Outcome Measures	Glyco-metabolic control [Time Frame: 9 months] [Designated as safety issue: Yes]Glyco-metabolic control will be assessed evaluating glycated hemoglobin, fasting plasma glucose and post-prandial glucose.

Descriptive Information[ + expand ][ + ]

Brief Title	Triple Therapy in Type 2 Diabetic Patients
Official Title	Effects on Glycemic Variability and Glyco-metabolic Control of Metformin, Pioglitazone and Sitagliptin in Type 2 Diabetic Patients
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Metformin Metformin will be added to therapy for the first threre months. Other Names: 500 mg three times a dayDrug: 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 dayDrug: 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
Study Arm (s)	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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	64
Estimated Completion Date	June 2016
Estimated Primary Completion Date	June 2014
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Giuseppe Derosa, MD, PhD giuseppe.derosa@unipv.it
Location Countries	Italy

Administrative Information[ + expand ][ + ]

NCT Number	NCT01895569
Other Study ID Numbers	20120021548
Has Data Monitoring Committee	No
Information Provided By	University of Pavia
Study Sponsor	University of Pavia
Collaborators	IRCCS Policlinico S. Matteo
Investigators	Principal Investigator: Giuseppe Derosa, MD, PhD IRCCS Policlinico San Matteo Foundation
Verification Date	July 2013

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