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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:
Collaborator:
Academic Research Collaborator: Population Health Research Institute / Hamilton Health
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00879970
First received: April 2, 2009
Last updated: October 3, 2016
Last verified: September 2016
Results First Received: November 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: pioglitazone
Drug: rosiglitazone
Drug: placebo
Dietary Supplement: Vitamin D
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
1332 participants were included in the TZD randomization, and 1221 of 1332 participants were included in the Vitamin D randomization.

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 a mean duration of 162 days.
Pioglitazone (PIO) PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
Rosiglitazone (RSG) RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
Vitamin D Placebo Vitamin D placebo administered for a mean duration of 162 days.
Vitamin D 1,000 IU/day administered for a mean duration of 162 days.

Participant Flow for 2 periods

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

Period 2:   Period 2 Vitamin D Randomization
    Placebo   Pioglitazone (PIO)   Rosiglitazone (RSG)   Vitamin D Placebo   Vitamin D
STARTED   0   0   0   614   607 
COMPLETED   0   0   0   610   600 
NOT COMPLETED   0   0   0   4   7 
Refused to Attend Final Visit                0                0                0                2                6 
Lost to Follow-up                0                0                0                0                1 
Death                0                0                0                2                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
Placebo Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
Pioglitazone (PIO) PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
Rosiglitazone (RSG) RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
Total Total of all reporting groups

Baseline Measures
   Placebo   Pioglitazone (PIO)   Rosiglitazone (RSG)   Total 
Overall Participants Analyzed 
[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 (up to 162 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 With Composite Microvascular Outcome   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

7.  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) ]

8.  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) ]

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

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

11.  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) ]

12.  Secondary:   Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

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

14.  Secondary:   Mean Score on Euro-QoL (EQ)-5D   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]

15.  Secondary:   Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF)   [ Time Frame: From Randomization at Visit 3 to Final Visit (up to 162 days) ]


  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
The intended duration of this study was approximately 5.5 years. However, the trial was stopped prematurely because of regulatory concerns after a mean of 162 days without consideration of the accrued data.


  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


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

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: October 3, 2016
Health Authority: United States: Food and Drug Administration