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

NCT00770653 | Completed Phase 3 Results

• 4 other identifiers: ATS K0242006-004455-37D-PIO-114U1111-1114-1678
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 64

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.

Conditions

Diabetes Mellitus; Dyslipidemias

Keywords

Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Hyperlipidemias; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 24.

Secondary Outcomes (31)

• Change From Baseline in High-Density Lipoprotein Cholesterol.

  Baseline and Week 24.

• Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.

  Baseline and Week 24.

• Change From Baseline in Triglycerides.

  Baseline and Week 24.

• Change From Baseline in Low-Density Lipoprotein Subfractions.

  Baseline and Week 24.

• Change From Baseline in Low-Density Lipoprotein Cholesterol.

  Baseline and Week 24.

Study Arms (2)

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

Interventions

Pioglitazone and Metformin DRUG

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.

Also known as: ACTOS®, AD-4833, OPIMET

Pioglitazone 15 mg and Metformin 850 mg BID

Glimepiride and Metformin DRUG

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.

Also known as: Amaryl, Glista

Glimepiride 2 mg and Metformin 850 mg BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Takeda: lead

Study Sites (64)

Unknown Facility

Bretten, Baden-Wurttemberg, Germany

Location

Unknown Facility

Deggingen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Dettenheim, Baden-Wurttemberg, Germany

Location

Unknown Facility

Künzelsau, Baden-Wurttemberg, Germany

Location

Unknown Facility

Rottweil, Baden-Wurttemberg, Germany

Location

Unknown Facility

Spaichingen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Stockach, Baden-Wurttemberg, Germany

Location

Unknown Facility

Wangen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Augsburg, Bavaria, Germany

Location

Unknown Facility

Feldafing, Bavaria, Germany

Location

Unknown Facility

Furth im Wald, Bavaria, Germany

Location

Unknown Facility

Immenstadt im Allgäu, Bavaria, Germany

Location

Unknown Facility

Lichtenfels, Bavaria, Germany

Location

Unknown Facility

München, Bavaria, Germany

Location

Unknown Facility

Schweinfurt, Bavaria, Germany

Location

Unknown Facility

Waldkraiburg, Bavaria, Germany

Location

Unknown Facility

Wallerfing, Bavaria, Germany

Location

Unknown Facility

Weilersbach, Bavaria, Germany

Location

Unknown Facility

Würzburg, Bavaria, Germany

Location

Unknown Facility

Ketzin, Brandenburg, Germany

Location

Unknown Facility

Rüdersdorf, Brandenburg, Germany

Location

Unknown Facility

Bermerhaven, City state Bremen, Germany

Location

Unknown Facility

Hamburg, Hamburg, Germany

Location

Unknown Facility

Bensheim, Hesse, Germany

Location

Unknown Facility

Ehrenberg, Hesse, Germany

Location

Unknown Facility

Gersfeld, Hesse, Germany

Location

Unknown Facility

Kassel, Hesse, Germany

Location

Unknown Facility

Kelkheim, Hesse, Germany

Location

Unknown Facility

Offenbach, Hesse, Germany

Location

Unknown Facility

Celle, Lower Saxony, Germany

Location

Unknown Facility

Einbeck, Lower Saxony, Germany

Location

Unknown Facility

Hanover, Lower Saxony, Germany

Location

Unknown Facility

Hildesheim, Lower Saxony, Germany

Location

Unknown Facility

Schwerin, Mecklenburg-Vorpommern, Germany

Location

Unknown Facility

Bad Berleburg, North Rhine-Westphalia, Germany

Location

Unknown Facility

Bad Laasphe, North Rhine-Westphalia, Germany

Location

Unknown Facility

Bad Oeynhausen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Bocholt, North Rhine-Westphalia, Germany

Location

Unknown Facility

Cologne, North Rhine-Westphalia, Germany

Location

Unknown Facility

Dinslaken, North Rhine-Westphalia, Germany

Location

Unknown Facility

Dorsten, North Rhine-Westphalia, Germany

Location

Unknown Facility

Duisburg, North Rhine-Westphalia, Germany

Location

Unknown Facility

Essen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Frechen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Isselburg, North Rhine-Westphalia, Germany

Location

Unknown Facility

Kamen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Marl, North Rhine-Westphalia, Germany

Location

Unknown Facility

Menden, North Rhine-Westphalia, Germany

Location

Unknown Facility

Münster, North Rhine-Westphalia, Germany

Location

Unknown Facility

Siegen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Diez, Rhineland-Palatinate, Germany

Location

Unknown Facility

Mainz, Rhineland-Palatinate, Germany

Location

Unknown Facility

Neuwied, Rhineland-Palatinate, Germany

Location

Unknown Facility

Rodenbach, Rhineland-Palatinate, Germany

Location

Unknown Facility

Simmern, Rhineland-Palatinate, Germany

Location

Unknown Facility

Borna, Saxony, Germany

Location

Unknown Facility

Dresden, Saxony, Germany

Location

Unknown Facility

Meissen, Saxony, Germany

Location

Unknown Facility

Mittweida, Saxony, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, Germany

Location

Unknown Facility

Reinfeld, Schleswig-Holstein, Germany

Location

Unknown Facility

Berlin, State of Berlin, Germany

Location

Unknown Facility

Altenburg, Thuringia, Germany

Location

Unknown Facility

Blankenhain, Thuringia, Germany

Location

Related Publications (1)

• 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.

  PMID: 21457065 DERIVED

Related Links

• ACTOPLUS MET® Package Insert

MeSH Terms

Conditions

Diabetes Mellitus; Dyslipidemias; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus, Lipoatrophic; Hyperlipidemias

Interventions

Pioglitazone; Metformin; glimepiride

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Medical Director
• Organization: Takeda Pharma GmbH, Aachen (Germany)

clinicaltrialregistry@tpna.com

+49 800 8253325

Study Officials

• Medical Adviser Clinical Research

  Takeda Pharma Gmbh, Aachen (Germany)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: April 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 6, 2010
• Results First Posted: October 6, 2010

Record last verified: 2010-09

Locations

DE (64)