Trial · NCT00879970
Thiazolidinedione Intervention With Vitamin D Evaluation
NCT00879970, Phase 4, Terminated, GlaxoSmithKline; results first posted 2011-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Thiazolidinedione Intervention With Vitamin D Evaluation. Trials, record NCT00879970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00879970
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thiazolidinedione Intervention With Vitamin D Evaluation
- NCT number
- NCT00879970
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 1,332 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- pioglitazone, rosiglitazone, placebo, Vitamin D, Placebo
- First posted
- 2009-04-13
- Last updated
- 2017-04-18
- Results first posted
- 2011-12-13
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | From Randomization at Visit 3 up to the Final Visit (average of 162 days) | An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function\[s\] due to disturbance in the blood supply to the brain not leading to death). |
| Primary | Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D | From Randomization at Visit 3 to Final Visit (up to 162 days) | An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery. |
| Secondary | Number of Participants With Any Revascularization | From Randomization at Visit 3 to Final Visit (up to 162 days) | Revascularization is defined as any surgical procedure for the provision of a new, additional, or augmented blood supply to heart muscle. Data regarding the need for any revascularization were adjudicated by the EAC and sent to the data monitoring committee (IDMC) on a regular basis for unblinded review. |
| Secondary | Number of Participants With Need for Hospitalization for Any Reason | From Randomization at Visit 3 to Final Visit (up to 162 days) | Data regarding the need for hospitalization for any reason were collected and were then forwarded to the independent data monitoring committee (IDMC) on a regular basis for unblinded review. |
| Secondary | Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina | From Randomization at Visit 3 to Final Visit (up to 162 days) | CHF is a condition in which the heart is not able to pump adequate blood to meet the body's needs. Shortness of breath is defined as difficulty in breathing. Pneumonia is an infection of the lungs, caused by various microorganisms. Angina is defined as severe chest pain due to lack of adequate blood supply of the heart muscle because of obstruction/spasm of the heart's blood vessels. Data regarding the need for hospitalization due to any of these reasons were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review. |
| Secondary | Number of Participants With Composite Microvascular Outcome | From Randomization at Visit 3 to Final Visit (up to 162 days) | The components of the composite microvascular outcome are retinopathy, decline in eGFR, vitrectomy, and renal replacement surgery. Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a \>=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data regarding the number of participants with changes in micro blood vessels (composite microvascular outcome) were collected at each visit. |
| Secondary | Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy | From Randomization at Visit 3 to Final Visit (up to 162 days) | Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a \>=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data on the number of participants with all of these microvascular outcomes were collected at each visit. Data regarding the number of participants with these microvascular outcomes were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review. |
| Secondary | Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia) | From Randomization at Visit 3 to Final Visit (up to 162 days) | Severe hypoglycemia is defined as hypoglycemia requiring assistance from another person with either a documented plasma glucose \<=36 mg/deciliter (2.0 millimole per liter \[mmol/L\]) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Hypoglycemia data were obtained from outcomes reported by the site. Data regarding hypoglycemia were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review. |
| Secondary | Number of Participants With Clinical Proteinuria | From Randomization at Visit 3 to Final Visit (up to 162 days) | Clinical proteinuria is defined as a laboratory detection of urinary protein excretion \> 0.5 grams (g) per 24 hours; spot urine analysis for albumin:creatinine ratio \>=300 milligrams/g; timed urine collection for albumin excretion \>=200 µg/minute or \>=300 mg/24 hours. Clinical proteinuria data were obtained from outcomes reported by the site. |
| Secondary | Number of Participants With a Fracture | From Randomization at Visit 3 to Final Visit (up to 162 days) | Fracture is defined as a medical condition in which there is a break in the continuity of the bone. Fractures are defined as those breaks that are self reported plus confirmed by an X-ray. Data regarding all occurrences of any fracture were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | From Randomization at Visit 3 up to the Final Visit (average of 162 days) | Intent-to-Treat (ITT) Population: all randomized participants | participants | NUMBER |
| PRIMARY | Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D | From Randomization at Visit 3 to Final Visit (up to 162 days) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Any Revascularization | From Randomization at Visit 3 to Final Visit (up to 162 days) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Need for Hospitalization for Any Reason | From Randomization at Visit 3 to Final Visit (up to 162 days) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina | From Randomization at Visit 3 to Final Visit (up to 162 days) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Composite Microvascular Outcome | From Randomization at Visit 3 to Final Visit (up to 162 days) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy | From Randomization at Visit 3 to Final Visit (up to 162 days) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia) | From Randomization at Visit 3 to Final Visit (up to 162 days) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Proteinuria | From Randomization at Visit 3 to Final Visit (up to 162 days) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With a Fracture | From Randomization at Visit 3 to Final Visit (up to 162 days) | ITT Population | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Placebo | CV Death/Non-Fatal MI/Non-Fatal Stroke | 5 | participants | |
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Pioglitazone (PIO) | CV Death/Non-Fatal MI/Non-Fatal Stroke | 2 | participants | |
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Rosiglitazone (RSG) | CV Death/Non-Fatal MI/Non-Fatal Stroke | 1 | participants | |
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Vitamin D Placebo | CV Death/Non-Fatal MI/Non-Fatal Stroke | 3 | participants | |
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Vitamin D | CV Death/Non-Fatal MI/Non-Fatal Stroke | 2 | participants | |
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Placebo | CV Death | 1 | participants | |
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Pioglitazone (PIO) | CV Death | 0 | participants | |
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Rosiglitazone (RSG) | CV Death | 0 | participants | |
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Vitamin D Placebo | CV Death | 1 | participants | |
| Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD) | Vitamin D | CV Death | 0 | participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 TZD Randomization | STARTED | Placebo | 541 | |
| Period 1 TZD Randomization | STARTED | Pioglitazone (PIO) | 392 | |
| Period 1 TZD Randomization | STARTED | Rosiglitazone (RSG) | 399 | |
| Period 1 TZD Randomization | STARTED | Vitamin D Placebo | 0 | |
| Period 1 TZD Randomization | STARTED | Vitamin D | 0 | |
| Period 1 TZD Randomization | COMPLETED | Placebo | 533 | |
| Period 1 TZD Randomization | COMPLETED | Pioglitazone (PIO) | 388 | |
| Period 1 TZD Randomization | COMPLETED | Rosiglitazone (RSG) | 393 | |
| Period 1 TZD Randomization | COMPLETED | Vitamin D Placebo | 0 | |
| Period 1 TZD Randomization | COMPLETED | Vitamin D | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events440
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina pectoris | Cardiac disorders | Placebo | 0 | 541 | |
| other | Angina pectoris | Cardiac disorders | Pioglitazone | 1 | 392 | |
| other | Angina pectoris | Cardiac disorders | Rosiglitazone | 0 | 399 | |
| other | Angina pectoris | Cardiac disorders | Vitamin D Placebo | 0 | 0 | |
| other | Angina pectoris | Cardiac disorders | Vitamin D | 0 | 0 | |
| other | Cardiac failure | Cardiac disorders | Placebo | 3 | 541 | |
| other | Cardiac failure | Cardiac disorders | Pioglitazone | 2 | 392 | |
| other | Cardiac failure | Cardiac disorders | Rosiglitazone | 0 | 399 | |
| other | Cardiac failure | Cardiac disorders | Vitamin D Placebo | 0 | 0 | |
| other | Cardiac failure | Cardiac disorders | Vitamin D | 0 | 0 |
1 to 10 of 440Source ClinicalTrials.gov
See all 440 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pioglitazone | ||
| Total, all-cause mortality | Rosiglitazone | ||
| Total, all-cause mortality | Vitamin D Placebo | ||
| Total, all-cause mortality | Vitamin D | ||
| Total, other adverse events | Placebo | 36 | 541 |
| Total, other adverse events | Pioglitazone | 35 | 392 |
| Total, other adverse events | Rosiglitazone | 21 | 399 |
| Total, other adverse events | Vitamin D Placebo | 0 | 0 |
| Total, other adverse events | Vitamin D | 0 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Arithmetic Fluency Task | Secondary outcome | ConductCognition |
| Clock Drawing Task | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00879970
GET https://conductscience.org/api/trials/v1/NCT00879970/results?page=2