Trial record 1 of 1 for:    NCT00879970
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Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE)

This study has been terminated.
(FDA has placed the trial on full clinical hold.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00879970
First received: April 2, 2009
Last updated: July 11, 2013
Last verified: May 2013
Results First Received: November 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Dietary Supplement: vitamin D
Drug: pioglitazone
Drug: rosiglitazone
Drug: placebo
Dietary Supplement: placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization occurred subsequent to a 3-week rosiglitazone (RSG) and vitamin D Single-blind Run-in Phase to assess compliance and tolerability. Participants received an RSG tablet (4 milligrams [mg]) and a vitamin D tablet (1000 international units [IU]) once a day.

Reporting Groups
  Description
Placebo Matching placebo tablet was administered once a day (OD) for the duration of 5.5 years
Pioglitazone (PIO) PIO tablet was administered in the dose of 30 milligrams (mg) OD initially and could be titrated to a maximum dose of 45 mg at or after the 6-month visit. After 1 year of treatment, the dose of PIO was increased to 45 mg OD for the duration of 5.5 years.
Rosiglitazone (RSG) RSG tablet was administered in the dose of 4 mg OD initially and could be titrated to a maximum dose of 8 mg at or after the 6-month visit. After 1 year of treatment, the dose of RSG was increased to 8 mg OD for the duration of 5.5 years.

Participant Flow:   Overall Study
    Placebo     Pioglitazone (PIO)     Rosiglitazone (RSG)  
STARTED     541     392     399  
COMPLETED     533     388     393  
NOT COMPLETED     8     4     6  
Refused to Attend Final Visit                 3                 3                 4  
Lost to Follow-up                 1                 0                 1  
Death                 2                 1                 0  
Final or Study Hold Visits Not Completed                 2                 0                 1  



  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
Placebo Matching placebo tablet was administered OD for the duration of 5.5 yrs
Pioglitazone PIO tablet was administered in the dose of 30 milligrams (mg) OD initially and could be titrated to a maximum dose of 45 mg at or after the 6-month visit. After 1 year of treatment, the dose of PIO was increased to 45 mg OD for the duration of 5.5 years.
Rosiglitazone RSG tablet was administered in the dose of 4 mg OD initially and could be titrated to a maximum dose of 8 mg at or after the 6-month visit. After 1 year of treatment, the dose of RSG was increased to 8 mg OD for the duration of 5.5 years.
Total Total of all reporting groups

Baseline Measures
    Placebo     Pioglitazone     Rosiglitazone     Total  
Number of Participants  
[units: participants]
  541     392     399     1332  
Age  
[units: Years]
Mean ± Standard Deviation
  66.4  ± 6.8     66.3  ± 6.6     66.5  ± 6.4     66.4  ± 6.6  
Gender  
[units: Participants]
       
Female     220     167     161     548  
Male     321     225     238     784  
Race/Ethnicity, Customized  
[units: participants]
       
European/ Caucasian/ White     330     241     255     826  
Unknown     53     34     35     122  
South Asian     63     46     48     157  
Black African     45     35     26     106  
Native South American     33     26     24     83  
Other Asian     10     6     6     22  
Native North American     1     2     4     7  
Japanese     1     0     1     2  
Arab/ Persian     1     1     0     2  
Native Hawaiian/ Australian or Other Asian Pacific     1     1     0     2  
Malays     1     0     0     1  
Sub-Saharan African     1     0     0     1  
Missing     1     0     0     1  



  Outcome Measures
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1.  Primary:   Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD)   [ Time Frame: From Randomization at Visit 3 up to the Final Visit (average of 162 days) ]

2.  Primary:   Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D   [ Time Frame: From Randomization at Visit 3 to Final Visit (average of 130 days) ]

3.  Secondary:   Number of Participants With Any Revascularization   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

4.  Secondary:   Number of Participants With Need for Hospitalization for Any Reason   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

5.  Secondary:   Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

6.  Secondary:   Number of Participants Who Died   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

7.  Secondary:   Number of Participants With Any Cancer   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

8.  Secondary:   Number of Participants With Composite Microvascular Outcome   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

9.  Secondary:   Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

10.  Secondary:   Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia)   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

11.  Secondary:   Number of Participants With Clinical Proteinuria   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

12.  Secondary:   Number of Participants With a Fracture   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

13.  Secondary:   Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

14.  Secondary:   Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit   [ Time Frame: Baseline, Year 2 Visit, and Final Visit (up to Year 5.5) ]

15.  Secondary:   Number of Participants With Erectile Dysfunction   [ Time Frame: At Randomization at Visit 3 and Final Visit (up to Year 5.5) ]

16.  Secondary:   Mean Score on Euro-QoL (EQ)-5D   [ Time Frame: At Randomization at Visit 3 and Final Visit (up to Year 5.5) ]

17.  Secondary:   Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF)   [ Time Frame: At Randomization at Visit 3 and Final Visit (up to Year 5.5) ]


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00879970     History of Changes
Other Study ID Numbers: 111960
Study First Received: April 2, 2009
Results First Received: November 10, 2011
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration