Type 2 Diabetes MellitusPhase 4NCT01895569
Triple Therapy in Type 2 Diabetic Patients
A Phase 4 study testing Metformin, Pioglitazone and Sitagliptin in people with Type 2 Diabetes Mellitus, run by University of Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Metformin, Pioglitazone and Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetic patients
- naive to therapy
- glycated hemoglobin > 6.5 and < 9.0 %
Who cannot join
- hepatic and renal diseases
- recent cardiovascular diseases
- previous pancreatitis
- history of cancer
Trial locations and contacts
1 site in 1 country.
Giuseppe Derosa, MD, PhD contact
Pamela Maffioli, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico S. Matteo Foundation
Pavia, 27100
Giuseppe Derosa, MD, PhD, giuseppe.derosa@unipv.it
Pamela Maffioli, MD, pamelamaffioli@hotmail.it
About this study
Official title: Effects on Glycemic Variability and Glyco-metabolic Control of Metformin, Pioglitazone and Sitagliptin in Type 2 Diabetic Patients
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Metformin, Pioglitazone, Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called 500 mg three times a day
Metformin will be added to therapy for the first threre months.
PioglitazoneDrug
Also called 15 mg twice a day
In patients not well controlled (glycated hemoglobin >6.5%) after three months of metformin, pioglitazone will be added.
SitagliptinDrug
Also called 100 mg once a day
In patients not well controlled (glycated hemoglobin >6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic patients | Experimental | 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. Receives: Drug: Metformin; Drug: Pioglitazone; Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variability
Glycemic variability will be assessed at the baseline, and every three months, using a continuous glucose monitoring system.
Measured: 9 months
Secondary outcomes (1)
Glyco-metabolic control
Glyco-metabolic control will be assessed evaluating glycated hemoglobin, fasting plasma glucose and post-prandial glucose.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
- Investigators
- Giuseppe Derosa, MD, PhD, Principal investigator, IRCCS Policlinico San Matteo Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895569
- Sponsor's protocol ID
- 20120021548
- Status last verified
- Jul 2013
- First submitted
- 30 Jun 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Glycemic Variability and Glyco-metabolic Control of Metformin, Pioglitazone and Sitagliptin in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01895569
- Acronym / sponsor ID
- 20120021548
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patients | Experimental | Drug: Metformin, Drug: Pioglitazone, Drug: SitagliptinType 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetic patients
- naive to therapy
- glycated hemoglobin > 6.5 and < 9.0 %
Key exclusion criteria (4 listed)
- hepatic and renal diseases
- recent cardiovascular diseases
- previous pancreatitis
- history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: 500 mg three times a dayMetformin will be added to therapy for the first threre months. | Drug | Type 2 diabetic patients |
| PioglitazoneAlso: 15 mg twice a dayIn patients not well controlled (glycated hemoglobin >6.5%) after three months of metformin, pioglitazone will be added. | Drug | Type 2 diabetic patients |
| SitagliptinAlso: 100 mg once a dayIn patients not well controlled (glycated hemoglobin >6.5%) after three months of metformin and pioglitazone, sitagliptin will be added. | Drug | Type 2 diabetic patients |
Primary outcome
Glycemic variability
Time frame: 9 months
Glycemic variability will be assessed at the baseline, and every three months, using a continuous glucose monitoring system.
1 secondary outcome
Glyco-metabolic control
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Derosa, MD, PhD contact
Pamela Maffioli, MD contact
Giuseppe Derosa, MD, PhD principal investigator
IRCCS Policlinico San Matteo Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin, Pioglitazone and Sitagliptin in people with Type 2 Diabetes Mellitus, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Derosa, MD, PhD (giuseppe.derosa@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic variability (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013; AzTrials last refreshed its copy on 6 Nov 2026.