Trial · NCT00683878
Add-on to Thiazolidinedione (TZD) Failures
NCT00683878, Phase 3, Completed, AstraZeneca; results first posted 2017-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Add-on to Thiazolidinedione (TZD) Failures. Trials, record NCT00683878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00683878
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Add-on to Thiazolidinedione (TZD) Failures
- NCT number
- NCT00683878
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 972 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 2 Diabetes
- Interventions
- Dapagliflozin, Dapagliflozin, Placebo matching Dapagliflozin, Thiazolidinedione (Pioglitazone)
- First posted
- 2008-05-26
- Last updated
- 2017-02-23
- Results first posted
- 2017-02-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period. |
| Secondary | Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained on Day 1 and week 24 in the double-blind period. |
| Secondary | Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. |
| Secondary | Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period. |
| Secondary | Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model. |
| Secondary | Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in waist circumference at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period. |
| Secondary | Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight among subjects with baseline body mass index (BMI) ≥ 27 kg/m\^2 at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF) | % of hemoglobin | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF) | mg/dL | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF) | kg | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF) | mg/dL | MEAN |
| SECONDARY | Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) | Percentage of participants | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | All randomized participants who received study medication and had nonmissing waist circumference values at baseline and Week 24 (LOCF) | cm | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF]) | From Baseline to Week 24 | All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF) among subjects with baseline body mass index (BMI) ≥ 27 kg/m\^2 | kg | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) | PLACEBO + Pioglitazone | -0.42 | Standard Error 0.0834 | % of hemoglobin | |
| Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) | Dapagliflozin 5MG + Pioglitazone | -0.82 | Standard Error 0.0828 | % of hemoglobin | |
| Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) | Dapagliflozin 10MG + Pioglitazone | -0.97 | Standard Error 0.0828 | % of hemoglobin | |
| Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) | PLACEBO + Pioglitazone | -14.1 | Standard Error 6.421 | mg/dL | |
| Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) | Dapagliflozin 5MG + Pioglitazone | -65.1 | Standard Error 6.325 | mg/dL | |
| Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) | Dapagliflozin 10MG + Pioglitazone | -67.5 | Standard Error 6.359 | mg/dL | |
| Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) | PLACEBO + Pioglitazone | 1.64 | Standard Error 0.2760 | kg | |
| Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) | Dapagliflozin 5MG + Pioglitazone | 0.09 | Standard Error 0.2752 | kg | |
| Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) | Dapagliflozin 10MG + Pioglitazone | -0.14 | Standard Error 0.2753 | kg | |
| Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) | PLACEBO + Pioglitazone | -5.5 | Standard Error 2.893 | mg/dL |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PLACEBO + Pioglitazone | 139 | |
| Overall Study | STARTED | Dapagliflozin 5MG + Pioglitazone | 141 | |
| Overall Study | STARTED | Dapagliflozin 10MG + Pioglitazone | 140 | |
| Overall Study | COMPLETED | PLACEBO + Pioglitazone | 116 | |
| Overall Study | COMPLETED | Dapagliflozin 5MG + Pioglitazone | 125 | |
| Overall Study | COMPLETED | Dapagliflozin 10MG + Pioglitazone | 126 | |
| Overall Study | NOT COMPLETED | PLACEBO + Pioglitazone | 23 | |
| Overall Study | NOT COMPLETED | Dapagliflozin 5MG + Pioglitazone | 16 | |
| Overall Study | NOT COMPLETED | Dapagliflozin 10MG + Pioglitazone | 14 |
Source ClinicalTrials.gov
Adverse events57
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 | DYSLIPIDAEMIA | Metabolism and nutrition disorders | PLACEBO + Pioglitazone | 6 | 139 | 7 |
| other | DYSLIPIDAEMIA | Metabolism and nutrition disorders | Dapagliflozin 5MG + Pioglitazone | 8 | 141 | 8 |
| other | DYSLIPIDAEMIA | Metabolism and nutrition disorders | Dapagliflozin 10MG + Pioglitazone | 13 | 140 | 14 |
| other | NASOPHARYNGITIS | Infections and infestations | PLACEBO + Pioglitazone | 5 | 139 | 7 |
| other | NASOPHARYNGITIS | Infections and infestations | Dapagliflozin 5MG + Pioglitazone | 7 | 141 | 7 |
| other | NASOPHARYNGITIS | Infections and infestations | Dapagliflozin 10MG + Pioglitazone | 11 | 140 | 11 |
| other | DIARRHOEA | Gastrointestinal disorders | PLACEBO + Pioglitazone | 6 | 139 | 7 |
| other | DIARRHOEA | Gastrointestinal disorders | Dapagliflozin 5MG + Pioglitazone | 4 | 141 | 4 |
| other | DIARRHOEA | Gastrointestinal disorders | Dapagliflozin 10MG + Pioglitazone | 9 | 140 | 9 |
| other | BACK PAIN | Musculoskeletal and connective tissue disorders | PLACEBO + Pioglitazone | 2 | 139 | 3 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PLACEBO + Pioglitazone | ||
| Total, all-cause mortality | Dapagliflozin 5MG + Pioglitazone | ||
| Total, all-cause mortality | Dapagliflozin 10MG + Pioglitazone | ||
| Total, other adverse events | PLACEBO + Pioglitazone | 37 | 139 |
| Total, other adverse events | Dapagliflozin 5MG + Pioglitazone | 34 | 141 |
| Total, other adverse events | Dapagliflozin 10MG + Pioglitazone | 45 | 140 |
| Total, serious adverse events | PLACEBO + Pioglitazone | 1 | 139 |
| Total, serious adverse events | Dapagliflozin 5MG + Pioglitazone | 4 | 141 |
| Total, serious adverse events | Dapagliflozin 10MG + Pioglitazone | 2 | 140 |
Source ClinicalTrials.gov
Papers4
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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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.
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