Diabetes MellitusPhase 3NCT00770653
Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.
A Phase 3 study testing Pioglitazone and Metformin and Glimepiride and Metformin in people with Diabetes Mellitus and Dyslipidemias, run by Takeda at 64 sites in Germany.
Trial summary
The purpose of this study is to compare pioglitazone and metformin combination therapy, twice daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects with dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Dyslipidemias
- What is being tested?
- Pioglitazone and Metformin and Glimepiride and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 64 sitesGermany
- Study dates
- Apr 2007to May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes according to the American Diabetes Association Criteria.
- Treatment with individual maximal tolerated dose of metformin (850 - 2000 mg) as monotherapy within the last 12 weeks.
- Glycosylated Hemoglobin greater than or equal to 6.5% and less than or equal to 9%.
- Dyslipidemia defined as high-density lipoprotein cholesterol less than or equal to 1.03 mmol/l (40 mg/dL) and/or triglycerides greater than or equal to 1.7 mmol/l (150 mg/dL).
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Who cannot join
- Type 1 diabetes mellitus.
- Insulin-dependent type 2 diabetes mellitus.
- Treatment or history of treatment with any insulin formulation other than emergency for more than 2 weeks.
- Treatment with other oral antidiabetic drugs in addition to metformin within the last 12 weeks.
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
- Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Show all 30Show fewer
- Heparin (and heparin-like drugs)
- coumarin
- phenprocoumon
- hirudin
- Protein C
- Fondaparinux
- antithrombin III
- Peroxisome Proliferation Activating Receptor (gamma) agonists
- Treatment within the last 12 weeks with:
- fibrates
- gemfibrozil
- niacin
- months
- Rifampicin
- Changes in dosage of any statin treatment to lower low-density lipoprotein within 2 weeks before study entry and during study participation interval.
- Changes in dosage of any anticoagulant treatment with acetyl salicylic acid and/or clopidogrel within 2 weeks before study entry and during study participation interval.
- Start of statin and/or anticoagulant treatment during study participation interval.
- History of severe or multiple allergies and/ or acute severe infections.
- Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
- Progressive fatal disease.
- Any elective surgery during study participation.
- History of drug or alcohol abuse within the last 5 years.
- A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase and/or aspartate aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine greater than 1.2 mg/dL in women and greater than 1.5 mg/dL in men, glomerular filtration rate less than 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease as judged by the investigator, history of macular edema.
- Blood donation within the last 30 days.
Trial locations and contacts
64 sites in 1 country.
64 sites in 1 country
Germany64 sites
Study site
Altenburg, Thuringia
Study site
Augsburg, Bavaria
Study site
Bad Berleburg, North Rhine-Westphalia
Study site
Bad Laasphe, North Rhine-Westphalia
Study site
Bad Oeynhausen, North Rhine-Westphalia
Study site
Bensheim, Hesse
Study site
Berlin, State of Berlin
Study site
Bermerhaven, Free Hanseatic City of Bremen
Study site
Blankenhain, Thuringia
Study site
Bocholt, North Rhine-Westphalia
Study site
Borna, Saxony
Study site
Bretten, Baden-Wurttemberg
Study site
Celle, Lower Saxony
Study site
Cologne, North Rhine-Westphalia
Study site
Deggingen, Baden-Wurttemberg
Study site
Dettenheim, Baden-Wurttemberg
Study site
Diez, Rhineland-Palatinate
Study site
Dinslaken, North Rhine-Westphalia
Study site
Dorsten, North Rhine-Westphalia
Study site
Dresden, Saxony
Study site
Duisburg, North Rhine-Westphalia
Study site
Ehrenberg, Hesse
Study site
Einbeck, Lower Saxony
Study site
Essen, North Rhine-Westphalia
Study site
Feldafing, Bavaria
Study site
Frechen, North Rhine-Westphalia
Study site
Furth im Wald, Bavaria
Study site
Gersfeld, Hesse
Study site
Hamburg, Free and Hanseatic City of Hamburg
Study site
Hanover, Lower Saxony
Study site
Hildesheim, Lower Saxony
Study site
Immenstadt im Allgäu, Bavaria
Study site
Isselburg, North Rhine-Westphalia
Study site
Kamen, North Rhine-Westphalia
Study site
Kassel, Hesse
Study site
Kelkheim, Hesse
Study site
Ketzin, Brandenburg
Study site
Künzelsau, Baden-Wurttemberg
Study site
Lichtenfels, Bavaria
Study site
Magdeburg, Saxony-Anhalt
Study site
Mainz, Rhineland-Palatinate
Study site
Marl, North Rhine-Westphalia
Study site
Meissen, Saxony
Study site
Menden, North Rhine-Westphalia
Study site
Mittweida, Saxony
Study site
München, Bavaria
Study site
Münster, North Rhine-Westphalia
Study site
Neuwied, Rhineland-Palatinate
Study site
Offenbach, Hesse
Study site
Reinfeld, Schleswig-Holstein
Study site
Rodenbach, Rhineland-Palatinate
Study site
Rottweil, Baden-Wurttemberg
Study site
Rüdersdorf, Brandenburg
Study site
Schweinfurt, Bavaria
Study site
Schwerin, Mecklenburg-Vorpommern
Study site
Siegen, North Rhine-Westphalia
Study site
Simmern, Rhineland-Palatinate
Study site
Spaichingen, Baden-Wurttemberg
Study site
Stockach, Baden-Wurttemberg
Study site
Waldkraiburg, Bavaria
Study site
Wallerfing, Bavaria
Study site
Wangen, Baden-Wurttemberg
Study site
Weilersbach, Bavaria
Study site
Würzburg, Bavaria
About this study
Official title: Effects of a Pioglitazone/Metformin Fixed Combination in Comparison to Metformin in Combination With Glimepiride on Diabetic Dyslipidemia
The purpose of this study is to compare pioglitazone and metformin combination therapy, twice daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects with dyslipidemia.
Read the detailed description
Insulin resistance is a major endocrinopathy preceding the development of hyperglycemia, diabetic dyslipidemia and cardiovascular disease in type 2 diabetes. The most common pattern of dyslipidemia in patients with type 2 diabetes are elevated triglyceride levels, decreased hih-density lipoprotein cholesterol and a predominance of small dense low-density lipoprotein particles. Each of these dyslipidemia features is associated with an increased risk of cardiovascular events.
Pioglitazone and Metformin are established drugs which can be used for the treatment of type 2 diabetes. This study will investigate the effects of treatment with fixed Pioglitazone/Metformin combination therapy of Metformin and Glimepiride in Metformin-pretreated type 2 diabetic patients with dyslipidemia.
Total participation time in this study is anticipated to be approximately 24 weeks.
- Conditions
- Diabetes Mellitus, Dyslipidemias
- Being tested
- Pioglitazone and Metformin, Glimepiride and Metformin
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Hyperlipidemias, Drug Therapy
- Medical subject headings
- Diabetes Mellitus, Dyslipidemias, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Diabetes Mellitus, Lipoatrophic, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone and MetforminDrug
Also called ACTOS®, AD-4833, OPIMET
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
Glimepiride and MetforminDrug
Also called Amaryl, Glista
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone 15 mg and Metformin 850 mg BID | Experimental | Not described Receives: Drug: Pioglitazone and Metformin |
| Glimepiride 2 mg and Metformin 850 mg BID | Active comparator | Not described Receives: Drug: Glimepiride and Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.
The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
Measured: Baseline and Week 24.
Secondary outcomes (31)
Change From Baseline in High-Density Lipoprotein Cholesterol.
The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.
The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Triglycerides.
The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Low-Density Lipoprotein Subfractions.
The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Low-Density Lipoprotein Cholesterol.
The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Glycosylated Hemoglobin.
The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Fasting Intact Proinsulin.
The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Fasting Glucose.
The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Adiponectin.
The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in High Sensitivity C-reactive Protein (Original).
The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).
The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Systolic Blood Pressure.
The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Diastolic Blood Pressure.
The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline.
Measured: Baseline and Week 24.
Intake of Study Medication Greater Than 80% and Less Than 120%.
The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Nitrotyrosine.
The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Soluble CD40 Ligand.
The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Matrix Metallo Proteinase-9.
The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Soluble Intracellular Adhesion Molecule.
The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Soluble Vascular Cell Adhesion Molecule.
The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Thromboxane B2.
The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Platelet Function.
The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in E-Selectin.
The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Von-Willebrand Factor.
The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (0.30%).
The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (0.60%)
The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (1.20).
The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (3.00).
The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (6.00).
The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (12.00).
The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (30.00).
The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (60.00).
The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Measured: Baseline and Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Adviser Clinical Research, Study director, Takeda Pharma Gmbh, Aachen (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770653
- Sponsor's protocol ID
- ATS K024
- Other IDs
- 2006-004455-37, D-PIO-114, U1111-1114-1678
- Status last verified
- Sep 2010
- First submitted
- 9 Oct 2008
- Last updated
- 6 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pfutzner A, Schondorf T, Tschope D, Lobmann R, Merke J, Muller J, Lehmann U, Fuchs W, Forst T. PIOfix-study: effects of pioglitazone/metformin fixed combination in comparison with a combination of metformin with glimepiride on diabetic dyslipidemia. Diabetes Technol Ther. 2011 Jun;13(6):637-43. doi: 10.1089/dia.2010.0233. Epub 2011 Apr 2.
PubMed 21457065
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pioglitazone/Metformin Fixed Combination in Comparison to Metformin in Combination With Glimepiride on Diabetic Dyslipidemia
- ClinicalTrials.gov ID
- NCT00770653
- Acronym / sponsor ID
- ATS K024
- Conditions
- Diabetes Mellitus, Dyslipidemias
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Hyperlipidemias, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 6 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare pioglitazone and metformin combination therapy, twice daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects with dyslipidemia.
Detailed description
Insulin resistance is a major endocrinopathy preceding the development of hyperglycemia, diabetic dyslipidemia and cardiovascular disease in type 2 diabetes. The most common pattern of dyslipidemia in patients with type 2 diabetes are elevated triglyceride levels, decreased hih-density lipoprotein cholesterol and a predominance of small dense low-density lipoprotein particles. Each of these dyslipidemia features is associated with an increased risk of cardiovascular events.
Pioglitazone and Metformin are established drugs which can be used for the treatment of type 2 diabetes. This study will investigate the effects of treatment with fixed Pioglitazone/Metformin combination therapy of Metformin and Glimepiride in Metformin-pretreated type 2 diabetic patients with dyslipidemia.
Total participation time in this study is anticipated to be approximately 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone 15 mg and Metformin 850 mg BID | Experimental | Drug: Pioglitazone and Metformin |
| Glimepiride 2 mg and Metformin 850 mg BID | Active comparator | Drug: Glimepiride and Metformin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes according to the American Diabetes Association Criteria.
- Treatment with individual maximal tolerated dose of metformin (850 - 2000 mg) as monotherapy within the last 12 weeks.
- Glycosylated Hemoglobin greater than or equal to 6.5% and less than or equal to 9%.
- Dyslipidemia defined as high-density lipoprotein cholesterol less than or equal to 1.03 mmol/l (40 mg/dL) and/or triglycerides greater than or equal to 1.7 mmol/l (150 mg/dL).
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Key exclusion criteria (30 listed)
- Type 1 diabetes mellitus.
- Insulin-dependent type 2 diabetes mellitus.
- Treatment or history of treatment with any insulin formulation other than emergency for more than 2 weeks.
- Treatment with other oral antidiabetic drugs in addition to metformin within the last 12 weeks.
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
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 |
|---|---|---|
| Pioglitazone and MetforminAlso: ACTOS®, AD-4833, OPIMETPioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks. | Drug | Pioglitazone 15 mg and Metformin 850 mg BID |
| Glimepiride and MetforminAlso: Amaryl, GlistaPioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks. | Drug | Glimepiride 2 mg and Metformin 850 mg BID |
Primary outcome
The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.
Time frame: Baseline and Week 24.
The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
31 secondary outcomes
Change From Baseline in High-Density Lipoprotein Cholesterol.
Time frame: Baseline and Week 24.
Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.
Time frame: Baseline and Week 24.
Change From Baseline in Triglycerides.
Time frame: Baseline and Week 24.
Change From Baseline in Low-Density Lipoprotein Subfractions.
Time frame: Baseline and Week 24.
Change From Baseline in Low-Density Lipoprotein Cholesterol.
Time frame: Baseline and Week 24.
Change From Baseline in Glycosylated Hemoglobin.
Time frame: Baseline and Week 24.
Change From Baseline in Fasting Intact Proinsulin.
Time frame: Baseline and Week 24.
Change From Baseline in Fasting Glucose.
Time frame: Baseline and Week 24.
Change From Baseline in Adiponectin.
Time frame: Baseline and Week 24.
Change From Baseline in High Sensitivity C-reactive Protein (Original).
Time frame: Baseline and Week 24.
Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).
Time frame: Baseline and Week 24.
Change From Baseline in Systolic Blood Pressure.
Time frame: Baseline and Week 24.
Change From Baseline in Diastolic Blood Pressure.
Time frame: Baseline and Week 24.
Intake of Study Medication Greater Than 80% and Less Than 120%.
Time frame: Baseline and Week 24.
Change From Baseline in Nitrotyrosine.
Time frame: Baseline and Week 24.
Change From Baseline in Soluble CD40 Ligand.
Time frame: Baseline and Week 24.
Change From Baseline in Matrix Metallo Proteinase-9.
Time frame: Baseline and Week 24.
Change From Baseline in Soluble Intracellular Adhesion Molecule.
Time frame: Baseline and Week 24.
Change From Baseline in Soluble Vascular Cell Adhesion Molecule.
Time frame: Baseline and Week 24.
Change From Baseline in Thromboxane B2.
Time frame: Baseline and Week 24.
Change From Baseline in Platelet Function.
Time frame: Baseline and Week 24.
Change From Baseline in E-Selectin.
Time frame: Baseline and Week 24.
Change From Baseline in Von-Willebrand Factor.
Time frame: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (0.30%).
Time frame: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (0.60%)
Time frame: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (1.20).
Time frame: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (3.00).
Time frame: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (6.00).
Time frame: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (12.00).
Time frame: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (30.00).
Time frame: Baseline and Week 24.
Change From Baseline in Erythrocyte Deformability (60.00).
Time frame: Baseline and Week 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21457065Pfutzner A, Schondorf T, Tschope D, Lobmann R, Merke J, Muller J, Lehmann U, Fuchs W, Forst T. PIOfix-study: effects of pioglitazone/metformin fixed combination in comparison with a combination of metformin with glimepiride on diabetic dyslipidemia. Diabetes Technol Ther. 2011 Jun;13(6):637-43. doi: 10.1089/dia.2010.0233. Epub 2011 Apr 2.
- ACTOPLUS MET® Package InsertLink provided by the sponsor.
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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.
Medical Adviser Clinical Research study director
Takeda Pharma Gmbh, Aachen (Germany)
64 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pioglitazone and Metformin and Glimepiride and Metformin in people with Diabetes Mellitus and Dyslipidemias, run by Takeda at 64 sites in Germany.
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 5 inclusion and 30 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: finished, as of the sponsor's last update on 6 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol. (time frame: Baseline and Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00770653, which also lists 1 linked publication.
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 6 Oct 2010.