Trial · NCT02068443
Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy
NCT02068443, Phase 3, Completed, Takeda; results first posted 2016-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy. Trials, record NCT02068443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02068443
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy
- NCT number
- NCT02068443
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 374 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Alogliptin, Metformin hydrochloride, Metformin hydrochloride Placebo
- First posted
- 2014-02-21
- Last updated
- 2023-09-28
- Results first posted
- 2016-06-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period | Baseline and End of Treatment (EOT) (Up to Week 24) | The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at End of Treatment Period relative to Baseline. A negative change from Baseline indicates improvement. An Analysis of Covariate (ANCOVA) model with change from Baseline as a dependent variable and Baseline and treatment as independent variables was used for main analyses. |
| Secondary | Change From Baseline in HbA1c (NGSP) | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24) | The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 2, 4, 8, 12, 16, 20, 24, and EOT relative to Baseline. A negative change from Baseline indicates improvement. |
| Secondary | HbA1c (NGSP) | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24) | The value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and EOT. |
| Secondary | Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period | Baseline and EOT (Up to Week 24) | HbA1c (NGSP) is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The percentage of participants with HbA1c levels of ≥6.0, ≥7.0 and ≥8.0 at the end of Screening (Baseline) with change to target values \<6.0, \<7.0 and \<8.0 respectively at EOT. |
| Secondary | Change From Baseline in Fasting Blood Glucose | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24) | The change in the value of the fasting plasma glucose collected at Weeks 2, 4, 8, 12, 16, 20 and 24 relative to Baseline. A negative change from Baseline indicates improvement. |
| Secondary | Fasting Blood Glucose | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24) | The value of the fasting plasma glucose collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT. |
| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) | 24 Weeks | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
| Secondary | Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | 24 Weeks | The percentage of participants with any clinically relevant safety laboratory changes (chemistry, hematology and urinalysis) collected throughout study and recorded as AEs. |
| Secondary | Percentage of Participants With TEAEs Related to Vital Signs | 24 Weeks | Vital signs included sitting systolic and diastolic blood pressures (mmHg) (measured after resting for ≥ 5 minutes) and pulse rate (beats per minute \[bpm\]). |
| Secondary | Number of Participants Who Had Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Findings | Baseline and Weeks 12 and 24 | Number of participants who had ECG findings changed from "normal" or "abnormal but not clinically relevant" at Baseline to "abnormal and clinically relevant". |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period | Baseline and End of Treatment (EOT) (Up to Week 24) | Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. | percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HbA1c (NGSP) | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24) | FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. | percent | MEAN |
| SECONDARY | HbA1c (NGSP) | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24) | FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. | percent | MEAN |
| SECONDARY | Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period | Baseline and EOT (Up to Week 24) | FAS included all randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Blood Glucose | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24) | FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. | mg/dL | MEAN |
| SECONDARY | Fasting Blood Glucose | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24) | FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. | mg/dL | MEAN |
| SECONDARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) | 24 Weeks | Safety Analysis Set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis | 24 Weeks | Safety Analysis Set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With TEAEs Related to Vital Signs | 24 Weeks | Safety Analysis Set included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Had Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Findings | Baseline and Weeks 12 and 24 | Safety Analysis Set, all participants who received at least 1 dose of study drug, with ECG values normal or abnormal not clinically significant at Baseline. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group147
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period | Alogliptin Alone | 0.16 | Standard Error 0.072 | percent | |
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period | Alogliptin + Metformin Hydrochloride QD | -0.49 | Standard Error 0.049 | percent | |
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period | Alogliptin + Metformin Hydrochloride BID | -0.60 | Standard Error 0.049 | percent | |
| Change From Baseline in HbA1c (NGSP) | Alogliptin Alone | Week 2 (n=71, 152, 151) | 0.01 | Standard Deviation 0.197 | percent |
| Change From Baseline in HbA1c (NGSP) | Alogliptin + Metformin Hydrochloride QD | Week 2 (n=71, 152, 151) | -0.14 | Standard Deviation 0.203 | percent |
| Change From Baseline in HbA1c (NGSP) | Alogliptin + Metformin Hydrochloride BID | Week 2 (n=71, 152, 151) | -0.19 | Standard Deviation 0.212 | percent |
| Change From Baseline in HbA1c (NGSP) | Alogliptin Alone | Week 4 (n=70, 150, 150) | 0.01 | Standard Deviation 0.316 | percent |
| Change From Baseline in HbA1c (NGSP) | Alogliptin + Metformin Hydrochloride QD | Week 4 (n=70, 150, 150) | -0.28 | Standard Deviation 0.279 | percent |
| Change From Baseline in HbA1c (NGSP) | Alogliptin + Metformin Hydrochloride BID | Week 4 (n=70, 150, 150) | -0.35 | Standard Deviation 0.298 | percent |
| Change From Baseline in HbA1c (NGSP) | Alogliptin Alone | Week 8 (n=68, 149, 149) | -0.01 | Standard Deviation 0.402 | percent |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alogliptin Alone | 71 | |
| Overall Study | STARTED | Alogliptin + Metformin Hydrochloride QD | 152 | |
| Overall Study | STARTED | Alogliptin + Metformin Hydrochloride BID | 151 | |
| Overall Study | COMPLETED | Alogliptin Alone | 64 | |
| Overall Study | COMPLETED | Alogliptin + Metformin Hydrochloride QD | 146 | |
| Overall Study | COMPLETED | Alogliptin + Metformin Hydrochloride BID | 148 | |
| Overall Study | NOT COMPLETED | Alogliptin Alone | 7 | |
| Overall Study | NOT COMPLETED | Alogliptin + Metformin Hydrochloride QD | 6 | |
| Overall Study | NOT COMPLETED | Alogliptin + Metformin Hydrochloride BID | 3 |
Source ClinicalTrials.gov
Adverse events51
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 | Nasopharyngitis | Infections and infestations | Alogliptin Alone | 8 | 71 | |
| other | Nasopharyngitis | Infections and infestations | Alogliptin + Metformin Hydrochloride QD | 22 | 152 | |
| other | Nasopharyngitis | Infections and infestations | Alogliptin + Metformin Hydrochloride BID | 19 | 151 | |
| other | Pharyngitis | Infections and infestations | Alogliptin Alone | 3 | 71 | |
| other | Pharyngitis | Infections and infestations | Alogliptin + Metformin Hydrochloride QD | 3 | 152 | |
| other | Pharyngitis | Infections and infestations | Alogliptin + Metformin Hydrochloride BID | 9 | 151 | |
| other | Hypoaesthesia | Nervous system disorders | Alogliptin Alone | 4 | 71 | |
| other | Hypoaesthesia | Nervous system disorders | Alogliptin + Metformin Hydrochloride QD | 1 | 152 | |
| other | Hypoaesthesia | Nervous system disorders | Alogliptin + Metformin Hydrochloride BID | 0 | 151 | |
| serious | Diverticulitis | Infections and infestations | Alogliptin Alone | 1 | 71 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alogliptin Alone | ||
| Total, all-cause mortality | Alogliptin + Metformin Hydrochloride QD | ||
| Total, all-cause mortality | Alogliptin + Metformin Hydrochloride BID | ||
| Total, other adverse events | Alogliptin Alone | 15 | 71 |
| Total, other adverse events | Alogliptin + Metformin Hydrochloride QD | 25 | 152 |
| Total, other adverse events | Alogliptin + Metformin Hydrochloride BID | 27 | 151 |
| Total, serious adverse events | Alogliptin Alone | 1 | 71 |
| Total, serious adverse events | Alogliptin + Metformin Hydrochloride QD | 3 | 152 |
| Total, serious adverse events | Alogliptin + Metformin Hydrochloride BID | 0 | 151 |
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.
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