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Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727857
First Posted: August 4, 2008
Last Update Posted: July 29, 2011
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: August 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: Pioglitazone and metformin
Drug: Pioglitazone
Drug: 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
Participants were enrolled at 134 investigative sites in the United States (including Puerto Rico), Argentina, Chile, Guatemala, Mexico and Peru from 13 June 2007 to 29 August 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who had not received treatment with antidiabetic medication 12 weeks prior to Screening were enrolled in one of three, twice-daily (BID) treatment groups.

Reporting Groups
  Description
Pioglitazone 15 mg/Metformin 850 mg BID Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
Pioglitazone 15 mg BID Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
Metformin 850 mg BID Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Participant Flow:   Overall Study
    Pioglitazone 15 mg/Metformin 850 mg BID   Pioglitazone 15 mg BID   Metformin 850 mg BID
STARTED   201   189   210 
COMPLETED   157   125   142 
NOT COMPLETED   44   64   68 



  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/Metformin 850 mg BID Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
Pioglitazone 15 mg BID Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
Metformin 850 mg BID Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
Total Total of all reporting groups

Baseline Measures
   Pioglitazone 15 mg/Metformin 850 mg BID   Pioglitazone 15 mg BID   Metformin 850 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 201   189   210   600 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.7  (12.23)   54.0  (12.08)   53.7  (12.00)   54.1  (12.09) 
Gender 
[Units: Participants]
       
Female   111   123   112   346 
Male   90   66   98   254 
Race/Ethnicity, Customized 
[Units: Participants]
       
American Indian or Alaska Native   2   6   6   14 
Asian   3   5   5   13 
Black or African American   12   13   14   39 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
White   123   109   124   356 
Multiracial   61   56   61   178 
Body Mass Index 
[Units: Kg/m²]
Mean (Standard Deviation)
 30.84  (5.74)   31.18  (5.50)   30.83  (5.66)   30.94  (5.63) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in Glycosylated Hemoglobin   [ Time Frame: Baseline and Week 24 ]

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

3.  Secondary:   Change From Baseline in Fasting Insulin   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Change From Baseline in Homeostasis Model Assessment - Insulin Resistance   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Median Percent Change From Baseline in High Sensitivity C-reactive Protein   [ Time Frame: Baseline and Week 24 ]

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

7.  Secondary:   Change From Baseline in Total Cholesterol   [ Time Frame: Baseline and Week 24 ]

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

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

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

11.  Secondary:   Change From Baseline in Mean Low Density Lipoprotein Particle Concentration   [ Time Frame: Baseline and Week 24 ]

12.  Secondary:   Change From Baseline in Mean Low Density Lipoprotein Particle Size   [ Time Frame: Baseline and Week 24 ]

13.  Secondary:   Change From Baseline in Large Low Density Lipoprotein (L3) Concentration   [ Time Frame: Baseline and Week 24 ]

14.  Secondary:   Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

15.  Secondary:   Change From Baseline in Medium-Small Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

16.  Secondary:   Change From Baseline in Small Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

17.  Secondary:   Change From Baseline in Very Small Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

18.  Secondary:   Change From Baseline in Mean High Density Lipoprotein Particle Concentration   [ Time Frame: Baseline and Week 24 ]

19.  Secondary:   Change From Baseline in Mean High Density Lipoprotein Particle Size   [ Time Frame: Baseline and Week 24 ]

20.  Secondary:   Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration   [ Time Frame: Baseline and Week 24 ]

21.  Secondary:   Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration   [ Time Frame: Baseline and Week 24 ]

22.  Secondary:   Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration   [ Time Frame: Baseline and Week 24 ]

23.  Secondary:   Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration   [ Time Frame: Baseline and Week 24 ]

24.  Secondary:   Change From Baseline in Mean Very Low Density Lipoprotein Particle Size   [ Time Frame: Baseline and Week 24 ]

25.  Secondary:   Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration   [ Time Frame: Baseline and Week 24 ]

26.  Secondary:   Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration   [ Time Frame: Baseline and Week 24 ]

27.  Secondary:   Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration   [ 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: Sr. VP Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:
Other Publications:

Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00727857     History of Changes
Other Study ID Numbers: 01-06-TL-OPIMET-008
U1111-1114-0371 ( Registry Identifier: WHO )
First Submitted: July 30, 2008
First Posted: August 4, 2008
Results First Submitted: August 28, 2009
Results First Posted: March 9, 2010
Last Update Posted: July 29, 2011