An observational study in Type 2 Diabetes Mellitus, sponsored by Takeda. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Takeda · Observational
The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.
The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more).
This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600.
This multi-center observational trial will be conducted in Japan.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 1,026 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with type 2 diabetes mellitus for whom combination therapy with alogliptin and metformin hydrochloride is appropriate in the opinion of a physician as the routine medical care.
Participants should meet one or more of the following:
Exclusion Criteria:
Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Drug: Alogliptin and Metformin hydrochloride
Alogliptin and Metformin hydrochloride combination tablets
Also known as: Inisync combination tablets
Percentage of Participants Who Had One or More Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 12 months
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
The change in 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 final assessment point (up to Month 12) relative to baseline.
Time frame: Baseline, up to final assessment point (up to Month 12)
Change From Baseline in Fasting Blood Glucose
The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline.
Time frame: Baseline, up to final assessment point (up to Month 12)
Change From Baseline in Fasting Insulin Level
The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.
Time frame: Baseline, up to final assessment point (up to Month 12)
Participants took part in the survey at 115 investigative sites in Japan, from 28 February 2017 to 31 October 2019.
| Milestone | Alogliptin and Metformin Hydrochloride |
|---|---|
| Started | 1026 |
| Completed | 1011 |
| Not completed | 15 |
| Withdrew: Case report forms uncollected | 2 |
| Withdrew: Protocol deviation | 13 |
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
| Percentage of Participants | Alogliptin and Metformin Hydrochloride |
|---|---|
| Percentage of Participants Who Had One or More Adverse Events | 5.93 |
The change in 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 final assessment point (up to Month 12) relative to baseline.
| Percent | Alogliptin and Metformin Hydrochloride |
|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | -0.259 ± 0.9633 |
The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline.
| milligram/deciliter (mg/dL) | Alogliptin and Metformin Hydrochloride |
|---|---|
| Change From Baseline in Fasting Blood Glucose | -12.08 ± 46.784 |
The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.
| microunit/milliliter (mcrU/mL) | Alogliptin and Metformin Hydrochloride |
|---|---|
| Change From Baseline in Fasting Insulin Level | 1.21 ± 13.852 |
Collected over Up to 12 months. Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alogliptin and Metformin Hydrochloride | 1/1,011 (0.1%) | 4/1,011 (0.4%) | 13/1,011 (1.3%) |
| Event | Alogliptin and Metformin Hydrochloride |
|---|---|
| Hepatocellular carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1011 |
| Atrial fibrillationCardiac disorders | 1/1011 |
| Deep vein thrombosisVascular disorders | 1/1011 |
| Large intestine polypGastrointestinal disorders | 1/1011 |
| Event | Alogliptin and Metformin Hydrochloride |
|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 1/1011 |
| DizzinessNervous system disorders | 1/1011 |
| Bundle branch block rightCardiac disorders | 1/1011 |
| PalpitationsCardiac disorders | 1/1011 |
| Chronic gastritisGastrointestinal disorders | 1/1011 |
| ConstipationGastrointestinal disorders | 1/1011 |
| Cold sweatSkin and subcutaneous tissue disorders | 1/1011 |
| Drug eruptionSkin and subcutaneous tissue disorders | 1/1011 |
| RashSkin and subcutaneous tissue disorders | 1/1011 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/1011 |
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Age, Continuous(Years) | Alogliptin and Metformin Hydrochloride |
|---|---|
| Mean | 68.0 ± 11.33 |
| Sex: Female, Male(Participants) | Alogliptin and Metformin Hydrochloride |
|---|---|
| Female | 402 |
| Male | 609 |
| Race and Ethnicity Not Collected(Participants) | Alogliptin and Metformin Hydrochloride |
|---|
| Region of Enrollment(Participants) | Alogliptin and Metformin Hydrochloride |
|---|---|
| Japan | 1011 |
| Duration of Diagnosis of Type 2 Diabetes Mellitus(Years) | Alogliptin and Metformin Hydrochloride |
|---|---|
| Mean | 8.64 ± 7.297 |
| Weight(Kilograms (kg)) | Alogliptin and Metformin Hydrochloride |
|---|---|
| Mean | 66.13 ± 13.640 |
| BMI(Kilogram (kg)/meter (m)^2) | Alogliptin and Metformin Hydrochloride |
|---|---|
| Mean | 25.47 ± 3.996 |
| Renal Impairment(Participants) | Alogliptin and Metformin Hydrochloride |
|---|---|
| Had No Renal Impairment | 638 |
| Had Renal Impairment | 373 |
14 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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