Trial · NCT02098746
Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
NCT02098746, Completed, Takeda; results first posted 2016-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone. Trials, record NCT02098746. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02098746
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
- NCT number
- NCT02098746
- Status
- Completed
- Enrollment
- 294 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Type 2 Diabetes
- Interventions
- Pioglitazone/glimepiride
- First posted
- 2014-03-28
- Last updated
- 2016-10-18
- Results first posted
- 2016-02-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Adverse Drug Reactions | 12 months | Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. |
| Primary | Frequency of Serious Adverse Drug Reactions | 12 months | Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, Months 3, 6, 9, 12 and at Final assessment | Tabulation of HbA1c values and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Fasting Blood Glucose Level | Baseline, Months 3, 6, 9, 12 and at Final assessment | Tabulation of fasting blood glucose level and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement. |
| Secondary | Change From Baseline in Fasting Insulin Level | Baseline, Months 3, 6, 9, 12 and at Final assessment | Tabulation of fasting insulin level and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Adverse Drug Reactions | 12 months | The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289). | participants | NUMBER |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, Months 3, 6, 9, 12 and at Final assessment | The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point. | percent | MEAN |
| SECONDARY | Change From Baseline in Fasting Blood Glucose Level | Baseline, Months 3, 6, 9, 12 and at Final assessment | The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting Insulin Level | Baseline, Months 3, 6, 9, 12 and at Final assessment | The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point. | μU/dL | MEAN |
| PRIMARY | Frequency of Serious Adverse Drug Reactions | 12 months | The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289). | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Frequency of Adverse Drug Reactions | Pioglitazone/Glimepiride | Anaemia | 1 | participants | |
| Frequency of Adverse Drug Reactions | Pioglitazone/Glimepiride | Hypoglycaemia | 7 | participants | |
| Frequency of Adverse Drug Reactions | Pioglitazone/Glimepiride | Generalised oedema | 1 | participants | |
| Frequency of Adverse Drug Reactions | Pioglitazone/Glimepiride | Oedema | 1 | participants | |
| Frequency of Adverse Drug Reactions | Pioglitazone/Glimepiride | Weight increased | 6 | participants | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Pioglitazone/Glimepiride | Month 3 (n=234) | -0.83 | Standard Deviation 1.030 | percent |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Pioglitazone/Glimepiride | Month 6 (n=190) | -0.84 | Standard Deviation 1.094 | percent |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Pioglitazone/Glimepiride | Month 9 (n=177) | -0.83 | Standard Deviation 1.088 | percent |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Pioglitazone/Glimepiride | Month 12 (n=84) | -0.62 | Standard Deviation 1.139 | percent |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Pioglitazone/Glimepiride | Final Assessment (n=247) | -0.92 | Standard Deviation 1.285 | percent |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pioglitazone/Glimepiride | 294 | |
| Overall Study | COMPLETED | Pioglitazone/Glimepiride | 289 | |
| Overall Study | NOT COMPLETED | Pioglitazone/Glimepiride | 5 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Pioglitazone/Glimepiride | 1 | 289 | |
| serious | Atrioventricular block complete | Cardiac disorders | Pioglitazone/Glimepiride | 1 | 289 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pioglitazone/Glimepiride | ||
| Total, other adverse events | Pioglitazone/Glimepiride | 0 | 289 |
| Total, serious adverse events | Pioglitazone/Glimepiride | 2 | 289 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT02098746
GET https://conductscience.org/api/trials/v1/NCT02098746/results?page=2