Trial · NCT00770653
Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.
NCT00770653, Phase 3, Completed, Takeda; results first posted 2010-10-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia. Trials, record NCT00770653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00770653
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.
- NCT number
- NCT00770653
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 305 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Diabetes Mellitus, Dyslipidemias
- Interventions
- Pioglitazone and Metformin, Glimepiride and Metformin
- First posted
- 2008-10-10
- Last updated
- 2010-10-06
- Other registries' IDs
- eudract:2006-004455-37
- Results first posted
- 2010-10-06
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol. | Baseline and Week 24. | The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline. |
| Secondary | Change From Baseline in High-Density Lipoprotein Cholesterol. | Baseline and Week 24. | The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline. |
| Secondary | Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio. | Baseline and Week 24. | The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline. |
| Secondary | Change From Baseline in Triglycerides. | Baseline and Week 24. | The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline. |
| Secondary | Change From Baseline in Low-Density Lipoprotein Subfractions. | Baseline and Week 24. | The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline. |
| Secondary | Change From Baseline in Low-Density Lipoprotein Cholesterol. | Baseline and Week 24. | The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin. | Baseline and Week 24. | The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Fasting Intact Proinsulin. | Baseline and Week 24. | The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline. |
| Secondary | Change From Baseline in Fasting Glucose. | Baseline and Week 24. | The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline. |
| Secondary | Change From Baseline in Adiponectin. | Baseline and Week 24. | The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol. | Baseline and Week 24. | Analysis was performed on participants with at least one valid baseline and post-baseline measurement. This condition was not fulfilled in 17 participants who were excluded from the all-participants-randomized set, leading to a full-analysis-set of 288 (146 vs. 142). Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High-Density Lipoprotein Cholesterol. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Triglycerides. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Low-Density Lipoprotein Subfractions. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Low-Density Lipoprotein Cholesterol. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Intact Proinsulin. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | pmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Glucose. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Adiponectin. | Baseline and Week 24. | Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination. | μg/mL | LEAST_SQUARES_MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol. | Pioglitazone 15 mg and Metformin 850 mg BID | 3.2 | Standard Error 9.7 | mg/dL | |
| The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol. | Glimepiride 2 mg and Metformin 850 mg BID | -0.3 | Standard Error 11.0 | mg/dL | |
| Change From Baseline in High-Density Lipoprotein Cholesterol. | Pioglitazone 15 mg and Metformin 850 mg BID | 3.3 | Standard Error 9.6 | mg/dL | |
| Change From Baseline in High-Density Lipoprotein Cholesterol. | Glimepiride 2 mg and Metformin 850 mg BID | -0.4 | Standard Error 11.1 | mg/dL | |
| Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio. | Pioglitazone 15 mg and Metformin 850 mg BID | 0.1 | Standard Error 0.8 | mg/dL | |
| Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio. | Glimepiride 2 mg and Metformin 850 mg BID | 0.3 | Standard Error 0.7 | mg/dL | |
| Change From Baseline in Triglycerides. | Pioglitazone 15 mg and Metformin 850 mg BID | -40.9 | Standard Error 113.8 | mg/dL | |
| Change From Baseline in Triglycerides. | Glimepiride 2 mg and Metformin 850 mg BID | -16.7 | Standard Error 121.6 | mg/dL | |
| Change From Baseline in Low-Density Lipoprotein Subfractions. | Pioglitazone 15 mg and Metformin 850 mg BID | 6.2 | Standard Error 17.5 | mg/dL | |
| Change From Baseline in Low-Density Lipoprotein Subfractions. | Glimepiride 2 mg and Metformin 850 mg BID | 6.1 | Standard Error 26.4 | mg/dL |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pioglitazone 15 mg and Metformin 850 mg BID | 155 | |
| Overall Study | STARTED | Glimepiride 2 mg and Metformin 850 mg BID | 150 | |
| Overall Study | COMPLETED | Pioglitazone 15 mg and Metformin 850 mg BID | 123 | |
| Overall Study | COMPLETED | Glimepiride 2 mg and Metformin 850 mg BID | 121 | |
| Overall Study | NOT COMPLETED | Pioglitazone 15 mg and Metformin 850 mg BID | 32 | |
| Overall Study | NOT COMPLETED | Glimepiride 2 mg and Metformin 850 mg BID | 29 |
Source ClinicalTrials.gov
Adverse events58
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Pioglitazone 15 mg and Metformin 850 mg BID | 8 | 153 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Glimepiride 2 mg and Metformin 850 mg BID | 3 | 149 | |
| other | Diarrhoea | Gastrointestinal disorders | Pioglitazone 15 mg and Metformin 850 mg BID | 14 | 153 | |
| other | Diarrhoea | Gastrointestinal disorders | Glimepiride 2 mg and Metformin 850 mg BID | 14 | 149 | |
| other | Headache | Nervous system disorders | Pioglitazone 15 mg and Metformin 850 mg BID | 7 | 153 | |
| other | Headache | Nervous system disorders | Glimepiride 2 mg and Metformin 850 mg BID | 7 | 149 | |
| other | Nasopharyngitis | Infections and infestations | Pioglitazone 15 mg and Metformin 850 mg BID | 24 | 153 | |
| other | Nasopharyngitis | Infections and infestations | Glimepiride 2 mg and Metformin 850 mg BID | 33 | 149 | |
| other | Oedema peripheral | General disorders | Pioglitazone 15 mg and Metformin 850 mg BID | 8 | 153 | |
| other | Oedema peripheral | General disorders | Glimepiride 2 mg and Metformin 850 mg BID | 4 | 149 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pioglitazone 15 mg and Metformin 850 mg BID | ||
| Total, all-cause mortality | Glimepiride 2 mg and Metformin 850 mg BID | ||
| Total, other adverse events | Pioglitazone 15 mg and Metformin 850 mg BID | 61 | 153 |
| Total, other adverse events | Glimepiride 2 mg and Metformin 850 mg BID | 61 | 149 |
| Total, serious adverse events | Pioglitazone 15 mg and Metformin 850 mg BID | 17 | 153 |
| Total, serious adverse events | Glimepiride 2 mg and Metformin 850 mg BID | 8 | 149 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21457065 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pioglitazone 15 mg and Metformin 850 mg BID vs Glimepiride 2 mg and Metformin 850 mg BID: Intake of Study Medication Greater Than 80% and Less Than 120%. | Trial comparisons |
| Pioglitazone 15 mg and Metformin 850 mg BID vs Glimepiride 2 mg and Metformin 850 mg BID: serious adverse events | Trial comparisons |
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.
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/NCT00770653
GET https://conductscience.org/api/trials/v1/NCT00770653/registered?page=2