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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770653
First Posted: October 10, 2008
Last Update Posted: October 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Takeda
Results First Submitted: September 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Dyslipidemias
Interventions: Drug: Pioglitazone and Metformin
Drug: Glimepiride and Metformin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 61 investigative sites in Germany from 03 April 2007 to 13 May 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with type 2 diabetes with diabetic dyslipidemia, inadequately controlled by Metformin monotherapy were enrolled in one of two, twice-daily (BID) combination therapy treatment groups.

Reporting Groups
  Description
Pioglitazone 15 mg and Metformin 850 mg BID 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 2 mg and Metformin 850 mg BID 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.

Participant Flow:   Overall Study
    Pioglitazone 15 mg and Metformin 850 mg BID   Glimepiride 2 mg and Metformin 850 mg BID
STARTED   155   150 
COMPLETED   123   121 
NOT COMPLETED   32   29 
Adverse Event                13                5 
Protocol Violation                8                6 
Withdrawal by Subject                4                7 
Lack of Compliance                1                4 
Worsening of Glycosolated Hemoglobin                2                2 
Fasting Glucose > 240 mg/dL                2                1 
> Three Moderate Hypoglycemic Episodes                0                2 
Lost to Follow-up                1                2 
Physician Decision                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pioglitazone 15 mg and Metformin 850 mg BID 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 2 mg and Metformin 850 mg BID 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.
Total Total of all reporting groups

Baseline Measures
   Pioglitazone 15 mg and Metformin 850 mg BID   Glimepiride 2 mg and Metformin 850 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 153   149   302 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.7  (10.0)   58.5  (9.6)   58.6  (9.8) 
Gender 
[Units: Participants]
     
Female   54   55   109 
Male   99   94   193 
Region of Enrollment 
[Units: Participants]
     
Germany   153   149   302 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.   [ Time Frame: Baseline and Week 24. ]

2.  Secondary:   Change From Baseline in High-Density Lipoprotein Cholesterol.   [ Time Frame: Baseline and Week 24. ]

3.  Secondary:   Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.   [ Time Frame: Baseline and Week 24. ]

4.  Secondary:   Change From Baseline in Triglycerides.   [ Time Frame: Baseline and Week 24. ]

5.  Secondary:   Change From Baseline in Low-Density Lipoprotein Subfractions.   [ Time Frame: Baseline and Week 24. ]

6.  Secondary:   Change From Baseline in Low-Density Lipoprotein Cholesterol.   [ Time Frame: Baseline and Week 24. ]

7.  Secondary:   Change From Baseline in Glycosylated Hemoglobin.   [ Time Frame: Baseline and Week 24. ]

8.  Secondary:   Change From Baseline in Fasting Intact Proinsulin.   [ Time Frame: Baseline and Week 24. ]

9.  Secondary:   Change From Baseline in Fasting Glucose.   [ Time Frame: Baseline and Week 24. ]

10.  Secondary:   Change From Baseline in Adiponectin.   [ Time Frame: Baseline and Week 24. ]

11.  Secondary:   Change From Baseline in High Sensitivity C-reactive Protein (Original).   [ Time Frame: Baseline and Week 24. ]

12.  Secondary:   Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).   [ Time Frame: Baseline and Week 24. ]

13.  Secondary:   Change From Baseline in Systolic Blood Pressure.   [ Time Frame: Baseline and Week 24. ]

14.  Secondary:   Change From Baseline in Diastolic Blood Pressure.   [ Time Frame: Baseline and Week 24. ]

15.  Secondary:   Intake of Study Medication Greater Than 80% and Less Than 120%.   [ Time Frame: Baseline and Week 24. ]

16.  Secondary:   Change From Baseline in Nitrotyrosine.   [ Time Frame: Baseline and Week 24. ]

17.  Secondary:   Change From Baseline in Soluble CD40 Ligand.   [ Time Frame: Baseline and Week 24. ]

18.  Secondary:   Change From Baseline in Matrix Metallo Proteinase-9.   [ Time Frame: Baseline and Week 24. ]

19.  Secondary:   Change From Baseline in Soluble Intracellular Adhesion Molecule.   [ Time Frame: Baseline and Week 24. ]

20.  Secondary:   Change From Baseline in Soluble Vascular Cell Adhesion Molecule.   [ Time Frame: Baseline and Week 24. ]

21.  Secondary:   Change From Baseline in Thromboxane B2.   [ Time Frame: Baseline and Week 24. ]

22.  Secondary:   Change From Baseline in Platelet Function.   [ Time Frame: Baseline and Week 24. ]

23.  Secondary:   Change From Baseline in E-Selectin.   [ Time Frame: Baseline and Week 24. ]

24.  Secondary:   Change From Baseline in Von-Willebrand Factor.   [ Time Frame: Baseline and Week 24. ]

25.  Secondary:   Change From Baseline in Erythrocyte Deformability (0.30%).   [ Time Frame: Baseline and Week 24. ]

26.  Secondary:   Change From Baseline in Erythrocyte Deformability (0.60%)   [ Time Frame: Baseline and Week 24. ]

27.  Secondary:   Change From Baseline in Erythrocyte Deformability (1.20).   [ Time Frame: Baseline and Week 24. ]

28.  Secondary:   Change From Baseline in Erythrocyte Deformability (3.00).   [ Time Frame: Baseline and Week 24. ]

29.  Secondary:   Change From Baseline in Erythrocyte Deformability (6.00).   [ Time Frame: Baseline and Week 24. ]

30.  Secondary:   Change From Baseline in Erythrocyte Deformability (12.00).   [ Time Frame: Baseline and Week 24. ]

31.  Secondary:   Change From Baseline in Erythrocyte Deformability (30.00).   [ Time Frame: Baseline and Week 24. ]

32.  Secondary:   Change From Baseline in Erythrocyte Deformability (60.00).   [ Time Frame: Baseline and Week 24. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda Pharma GmbH, Aachen (Germany)
phone: +49 800 8253325
e-mail: clinicaltrialregistry@tpna.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical Director, Takeda Pharma GmbH, Aachen (Germany)
ClinicalTrials.gov Identifier: NCT00770653     History of Changes
Other Study ID Numbers: ATS K024
2006-004455-37 ( EudraCT Number )
D-PIO-114 ( Other Identifier: Takeda Pharma GmbH )
U1111-1114-1678 ( Registry Identifier: WHO )
First Submitted: October 9, 2008
First Posted: October 10, 2008
Results First Submitted: September 13, 2010
Results First Posted: October 6, 2010
Last Update Posted: October 6, 2010



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