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Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.

Primary Purpose

Diabetes Mellitus, Dyslipidemias

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pioglitazone and Metformin
Glimepiride and Metformin
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Hyperlipidemias, Drug Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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:

    • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pioglitazone 15 mg and Metformin 850 mg BID

Glimepiride 2 mg and Metformin 850 mg BID

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change From Baseline in Triglycerides.
The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline.
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.
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.
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.
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.
Change From Baseline in Fasting Glucose.
The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline.
Change From Baseline in Adiponectin.
The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline.
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.
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.
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.
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.
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.
Change From Baseline in Nitrotyrosine.
The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 9, 2008
Last Updated
September 13, 2010
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00770653
Brief Title
Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.
Official Title
Effects of a Pioglitazone/Metformin Fixed Combination in Comparison to Metformin in Combination With Glimepiride on Diabetic Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Dyslipidemias
Keywords
Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Hyperlipidemias, Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone 15 mg and Metformin 850 mg BID
Arm Type
Experimental
Arm Title
Glimepiride 2 mg and Metformin 850 mg BID
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pioglitazone and Metformin
Other Intervention Name(s)
ACTOS®, AD-4833, OPIMET
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Glimepiride and Metformin
Other Intervention Name(s)
Amaryl, Glista
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.
Description
The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
Time Frame
Baseline and Week 24.
Secondary Outcome Measure Information:
Title
Change From Baseline in High-Density Lipoprotein Cholesterol.
Description
The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Triglycerides.
Description
The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Low-Density Lipoprotein Subfractions.
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Low-Density Lipoprotein Cholesterol.
Description
The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Glycosylated Hemoglobin.
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Fasting Intact Proinsulin.
Description
The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Fasting Glucose.
Description
The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Adiponectin.
Description
The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in High Sensitivity C-reactive Protein (Original).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Systolic Blood Pressure.
Description
The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Diastolic Blood Pressure.
Description
The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline.
Time Frame
Baseline and Week 24.
Title
Intake of Study Medication Greater Than 80% and Less Than 120%.
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Nitrotyrosine.
Description
The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Soluble CD40 Ligand.
Description
The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Matrix Metallo Proteinase-9.
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Soluble Intracellular Adhesion Molecule.
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Soluble Vascular Cell Adhesion Molecule.
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Thromboxane B2.
Description
The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Platelet Function.
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in E-Selectin.
Description
The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Von-Willebrand Factor.
Description
The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Erythrocyte Deformability (0.30%).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Erythrocyte Deformability (0.60%)
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Erythrocyte Deformability (1.20).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Erythrocyte Deformability (3.00).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Erythrocyte Deformability (6.00).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Erythrocyte Deformability (12.00).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Erythrocyte Deformability (30.00).
Description
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.
Time Frame
Baseline and Week 24.
Title
Change From Baseline in Erythrocyte Deformability (60.00).
Description
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.
Time Frame
Baseline and Week 24.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Adviser Clinical Research
Organizational Affiliation
Takeda Pharma Gmbh, Aachen (Germany)
Official's Role
Study Director
Facility Information:
City
Bretten
State/Province
Baden-Württemberg
Country
Germany
City
Deggingen
State/Province
Baden-Württemberg
Country
Germany
City
Dettenheim
State/Province
Baden-Württemberg
Country
Germany
City
Künzelsau
State/Province
Baden-Württemberg
Country
Germany
City
Rottweil
State/Province
Baden-Württemberg
Country
Germany
City
Spaichingen
State/Province
Baden-Württemberg
Country
Germany
City
Stockach
State/Province
Baden-Württemberg
Country
Germany
City
Wangen
State/Province
Baden-Württemberg
Country
Germany
City
Augsburg
State/Province
Bayern
Country
Germany
City
Feldafing
State/Province
Bayern
Country
Germany
City
Furth im Wald
State/Province
Bayern
Country
Germany
City
Immenstadt
State/Province
Bayern
Country
Germany
City
Lichtenfels
State/Province
Bayern
Country
Germany
City
München
State/Province
Bayern
Country
Germany
City
Schweinfurt
State/Province
Bayern
Country
Germany
City
Waldkraiburg
State/Province
Bayern
Country
Germany
City
Wallerfing
State/Province
Bayern
Country
Germany
City
Weilersbach
State/Province
Bayern
Country
Germany
City
Würzburg
State/Province
Bayern
Country
Germany
City
Ketzin
State/Province
Brandenburg
Country
Germany
City
Rüdersdorf
State/Province
Brandenburg
Country
Germany
City
Bermerhaven
State/Province
Bremen
Country
Germany
City
Bensheim
State/Province
Hessen
Country
Germany
City
Ehrenberg
State/Province
Hessen
Country
Germany
City
Gersfeld
State/Province
Hessen
Country
Germany
City
Kassel
State/Province
Hessen
Country
Germany
City
Kelkheim
State/Province
Hessen
Country
Germany
City
Offenbach
State/Province
Hessen
Country
Germany
City
Schwerin
State/Province
Mecklenburg-Vorpommern
Country
Germany
City
Celle
State/Province
Niedersachsen
Country
Germany
City
Einbeck
State/Province
Niedersachsen
Country
Germany
City
Hannover
State/Province
Niedersachsen
Country
Germany
City
Hildesheim
State/Province
Niedersachsen
Country
Germany
City
Bad Berleburg
State/Province
Nordrhein-Westfalen
Country
Germany
City
Bad Laasphe
State/Province
Nordrhein-Westfalen
Country
Germany
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
Country
Germany
City
Bocholt
State/Province
Nordrhein-Westfalen
Country
Germany
City
Dinslaken
State/Province
Nordrhein-Westfalen
Country
Germany
City
Dorsten
State/Province
Nordrhein-Westfalen
Country
Germany
City
Duisburg
State/Province
Nordrhein-Westfalen
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
Country
Germany
City
Frechen
State/Province
Nordrhein-Westfalen
Country
Germany
City
Isselburg
State/Province
Nordrhein-Westfalen
Country
Germany
City
Kamen
State/Province
Nordrhein-Westfalen
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
Country
Germany
City
Marl
State/Province
Nordrhein-Westfalen
Country
Germany
City
Menden
State/Province
Nordrhein-Westfalen
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
Country
Germany
City
Siegen
State/Province
Nordrhein-Westfalen
Country
Germany
City
Diez
State/Province
Rheinland-Pfalz
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
Country
Germany
City
Neuwied
State/Province
Rheinland-Pfalz
Country
Germany
City
Rodenbach
State/Province
Rheinland-Pfalz
Country
Germany
City
Simmern
State/Province
Rheinland-Pfalz
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
Country
Germany
City
Borna
State/Province
Sachsen
Country
Germany
City
Dresden
State/Province
Sachsen
Country
Germany
City
Meißen
State/Province
Sachsen
Country
Germany
City
Mittweida
State/Province
Sachsen
Country
Germany
City
Reinfeld
State/Province
Schleswig-Holstein
Country
Germany
City
Altenburg
State/Province
Thüringen
Country
Germany
City
Blankenhain
State/Province
Thüringen
Country
Germany
City
Berlin
Country
Germany
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21457065
Citation
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.
Results Reference
derived

Learn more about this trial

Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.

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