Trial · NCT02098733
Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus
NCT02098733, Completed, Takeda; results first posted 2016-04-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus. Trials, record NCT02098733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02098733
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus
- NCT number
- NCT02098733
- Status
- Completed
- Enrollment
- 1,168 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Type 2 Diabetes
- Interventions
- Pioglitazone/glimepiride
- First posted
- 2014-03-28
- Last updated
- 2016-04-15
- Results first posted
- 2016-04-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | For 12 months | 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. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, and Months 3, 6, 9, 12 and at Final Assessment | Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values 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 | Glycosylated Hemoglobin (HbA1c) | Baseline, and Months 3, 6, 9, 12 and at Final Assessment | Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline. |
| Secondary | Change From Baseline in Fasting Blood Glucose Level | Baseline, Months 3, 6, 9, 12 and at Final Assessment | Tabulated the changes from baseline in fasting blood glucose level 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 | Fasting Blood Glucose Level | Baseline, Months 3, 6, 9, 12 and at Final Assessment | Tabulated fasting blood glucose level from baseline at each test time point. |
| Secondary | Change From Baseline in Fasting Insulin Level | Baseline, Months 3, 6, 9, 12 and at Final Assessment | Tabulated 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 | Fasting Insulin Level | Baseline, Months 3, 6, 9, 12 and at Final Assessment | Tabulated fasting insulin level at each test time point. |
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 | Number of Participants With Adverse Drug Reactions | For 12 months | All enrolled participants with available data. | participants | NUMBER |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, and Months 3, 6, 9, 12 and at Final Assessment | All enrolled participants with data available. | percentage of glycosylated haemoglobin | MEAN |
| SECONDARY | Glycosylated Hemoglobin (HbA1c) | Baseline, and Months 3, 6, 9, 12 and at Final Assessment | All enrolled participants with data available. | percentage of glycosylated haemoglobin | MEAN |
| SECONDARY | Change From Baseline in Fasting Blood Glucose Level | Baseline, Months 3, 6, 9, 12 and at Final Assessment | All enrolled participants with data available. | mg/dL | MEAN |
| SECONDARY | Fasting Blood Glucose Level | Baseline, Months 3, 6, 9, 12 and at Final Assessment | All enrolled participants with data available. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Fasting Insulin Level | Baseline, Months 3, 6, 9, 12 and at Final Assessment | All enrolled participants with data available. | μU/dL | MEAN |
| SECONDARY | Fasting Insulin Level | Baseline, Months 3, 6, 9, 12 and at Final Assessment | All enrolled participants with data available. | μU/dL | MEAN |
Source ClinicalTrials.gov
Results by group59
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 Adverse Drug Reactions | Pioglitazone/Glimepiride | Hypoglycaemia | 13 | participants | |
| Number of Participants With Adverse Drug Reactions | Pioglitazone/Glimepiride | Dizziness | 4 | participants | |
| Number of Participants With Adverse Drug Reactions | Pioglitazone/Glimepiride | Dysgeusia | 1 | participants | |
| Number of Participants With Adverse Drug Reactions | Pioglitazone/Glimepiride | Headache | 1 | participants | |
| Number of Participants With Adverse Drug Reactions | Pioglitazone/Glimepiride | Hypoaesthesia | 1 | participants | |
| Number of Participants With Adverse Drug Reactions | Pioglitazone/Glimepiride | Cardiac failure | 2 | participants | |
| Number of Participants With Adverse Drug Reactions | Pioglitazone/Glimepiride | Cardiac failure congestive | 1 | participants | |
| Number of Participants With Adverse Drug Reactions | Pioglitazone/Glimepiride | Pleural effusion | 1 | participants | |
| Number of Participants With Adverse Drug Reactions | Pioglitazone/Glimepiride | Eructation | 1 | participants | |
| Number of Participants With Adverse Drug Reactions | Pioglitazone/Glimepiride | Nausea | 1 | participants |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 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 | 1,168 | |
| Overall Study | COMPLETED | Pioglitazone/Glimepiride | 1,158 | |
| Overall Study | NOT COMPLETED | Pioglitazone/Glimepiride | 10 |
Source ClinicalTrials.gov
Adverse events27
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 | Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Pioglitazone/Glimepiride | 1 | 1,158 | |
| serious | Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Pioglitazone/Glimepiride | 1 | 1,158 | |
| serious | Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Pioglitazone/Glimepiride | 1 | 1,158 | |
| serious | Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Pioglitazone/Glimepiride | 1 | 1,158 | |
| serious | Anaemia | Blood and lymphatic system disorders | Pioglitazone/Glimepiride | 1 | 1,158 | |
| serious | Hyperkalaemia | Metabolism and nutrition disorders | Pioglitazone/Glimepiride | 1 | 1,158 | |
| serious | Marasmus | Metabolism and nutrition disorders | Pioglitazone/Glimepiride | 1 | 1,158 | |
| serious | Completed suicide | Psychiatric disorders | Pioglitazone/Glimepiride | 1 | 1,158 | |
| serious | Cerebrovascular accident | Nervous system disorders | Pioglitazone/Glimepiride | 1 | 1,158 | |
| serious | Convulsion | Nervous system disorders | Pioglitazone/Glimepiride | 1 | 1,158 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse 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 | 1,158 |
| Total, serious adverse events | Pioglitazone/Glimepiride | 23 | 1,158 |
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/NCT02098733
GET https://conductscience.org/api/trials/v1/NCT02098733/results?page=2