Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"
Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT03555565
Collaborator
(none)
1,026
1
32
32
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
1026 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"
Actual Study Start Date
:
Feb 28, 2017
Actual Primary Completion Date
:
Oct 31, 2019
Actual Study Completion Date
:
Oct 31, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Alogliptin and Metformin hydrochloride 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Had One or More Adverse Events [Up to 12 months]
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.
Secondary Outcome Measures
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) [Baseline, up to final assessment point (up to Month 12)]
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.
- Change From Baseline in Fasting Blood Glucose [Baseline, up to final assessment point (up to Month 12)]
The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline.
- Change From Baseline in Fasting Insulin Level [Baseline, up to final assessment point (up to Month 12)]
The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Participants should meet one or more of the following:
-
Have renal impairment (mild)
-
Have hepatic impairment (mild or moderate)
-
Elderly (aged 65 years or more)
Exclusion Criteria:
- Participants with any contraindication for study drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Takeda Selected Site | Tokyo | Japan |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT03555565
Other Study ID Numbers:
- Alogliptin-Met-5003
- JapicCTI-183979
First Posted:
Jun 13, 2018
Last Update Posted:
Nov 23, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants took part in the survey at 115 investigative sites in Japan, from 28 February 2017 to 31 October 2019. |
|---|---|
| Pre-assignment Detail | Participants with a historical diagnosis of type 2 diabetes mellitus with renal or hepatic impairment or advanced age were enrolled. Participants received alogliptin and metformin hydrochloride combination tablets as part of a routine medical care. |
| Arm/Group Title | Alogliptin and Metformin Hydrochloride |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 1026 |
| COMPLETED | 1011 |
| NOT COMPLETED | 15 |
Baseline Characteristics
| Arm/Group Title | Alogliptin and Metformin Hydrochloride |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 1011 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
68.0
(11.33)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
402
39.8%
|
| Male |
609
60.2%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (Count of Participants) | |
| Japan |
1011
100%
|
| Duration of Diagnosis of Type 2 Diabetes Mellitus (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
8.64
(7.297)
|
| Weight (Kilograms (kg)) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Kilograms (kg)] |
66.13
(13.640)
|
| BMI (Kilogram (kg)/meter (m)^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Kilogram (kg)/meter (m)^2] |
25.47
(3.996)
|
| Renal Impairment (Count of Participants) | |
| Had No Renal Impairment |
638
63.1%
|
| Had Renal Impairment |
373
36.9%
|
| Hepatic Impairment (Count of Participants) | |
| Had No Hepatic Impairment |
545
53.9%
|
| Had Hepatic Impairment |
466
46.1%
|
| Healthcare Category (Count of Participants) | |
| Outpatient |
1006
99.5%
|
| Inpatient |
5
0.5%
|
| Predisposition to Hypersensitivity (Count of Participants) | |
| Had No Predisposition to Hypersensitivity |
826
81.7%
|
| Had Predisposition to Hypersensitivity |
82
8.1%
|
| Unknown |
103
10.2%
|
| Medical Complications (Count of Participants) | |
| Had No Medical Complications |
56
5.5%
|
| Had Medical Complications |
955
94.5%
|
| Medical History (Count of Participants) | |
| Had No Medical History |
629
62.2%
|
| Had Medical History |
267
26.4%
|
| Unknown |
115
11.4%
|
| Smoking Classification (Count of Participants) | |
| Never Smoked |
417
41.2%
|
| Current Smoker |
156
15.4%
|
| Ex-Smoker |
216
21.4%
|
| Unknown |
222
22%
|
| Drinking Habits (Count of Participants) | |
| Yes |
246
24.3%
|
| No |
570
56.4%
|
| Unknown |
195
19.3%
|
| Employment Status (Count of Participants) | |
| Not Employed |
495
49%
|
| Employed |
390
38.6%
|
| Unknown |
126
12.5%
|
| Hemoglobin A1c (HbA1c) Level (Percent) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Percent] |
7.336
(1.0710)
|
| Alogliptin-Equivalent Dose per Day Given Immediate Before the Study Drug (Count of Participants) | |
| < 25 milligrams (mg) |
14
1.4%
|
| 25 mg |
561
55.5%
|
| > 25 mg |
1
0.1%
|
| Metformin-Equivalent Dose per Day Given Immediately Before the Study Drug (Count of Participants) | |
| < 500 mg |
36
3.6%
|
| 500 mg |
505
50%
|
| > 500 mg |
189
18.7%
|
| Combination of Drugs for Type 2 Diabetes Mellitus Other than Alogliptin or Metformin (Count of Participants) | |
| Not Combined |
401
39.7%
|
| Combined |
610
60.3%
|
| Status of Treatment Compliance to Alogliptin Medication Within 3 Months prior to the Study Drug (Count of Participants) | |
| ≥ 90% |
487
48.2%
|
| ≥ 70% and < 90% |
46
4.5%
|
| ≥ 50% and < 70% |
8
0.8%
|
| < 50% |
17
1.7%
|
| Status of Treatment Compliance to Metformin Medication Within 3 Months prior to the Study Drug (Count of Participants) | |
| ≥ 90% |
618
61.1%
|
| ≥ 70% and < 90% |
67
6.6%
|
| ≥ 50% and < 70% |
17
1.7%
|
| < 50% |
15
1.5%
|
Outcome Measures
| Title | Percentage of Participants Who Had One or More Adverse Events |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. |
| Arm/Group Title | Alogliptin and Metformin Hydrochloride |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 1011 |
| Number [Percentage of Participants] |
5.93
0.6%
|
| Title | Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. |
| Arm/Group Title | Alogliptin and Metformin Hydrochloride |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 897 |
| Mean (Standard Deviation) [Percent] |
-0.259
(0.9633)
|
| Title | Change From Baseline in Fasting Blood Glucose |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. |
| Arm/Group Title | Alogliptin and Metformin Hydrochloride |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 468 |
| Mean (Standard Deviation) [milligram/deciliter (mg/dL)] |
-12.08
(46.784)
|
| Title | Change From Baseline in Fasting Insulin Level |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. |
| Arm/Group Title | Alogliptin and Metformin Hydrochloride |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 34 |
| Mean (Standard Deviation) [microunit/milliliter (mcrU/mL)] |
1.21
(13.852)
|
Adverse Events
| Time Frame | Up to 12 months | |
|---|---|---|
| Adverse Event Reporting Description | At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment. | |
| Arm/Group Title | Alogliptin and Metformin Hydrochloride | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Alogliptin and Metformin Hydrochloride | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/1011 (0.1%) | |
Serious Adverse Events |
||
| Alogliptin and Metformin Hydrochloride | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/1011 (0.4%) | |
| Cardiac disorders | ||
| Atrial fibrillation | 1/1011 (0.1%) | |
| Gastrointestinal disorders | ||
| Large intestine polyp | 1/1011 (0.1%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Hepatocellular carcinoma | 1/1011 (0.1%) | |
| Vascular disorders | ||
| Deep vein thrombosis | 1/1011 (0.1%) | |
Other (Not Including Serious) Adverse Events |
||
| Alogliptin and Metformin Hydrochloride | ||
| Affected / at Risk (%) | # Events | |
| Total | 13/1011 (1.3%) | |
| Cardiac disorders | ||
| Bundle branch block right | 1/1011 (0.1%) | |
| Palpitations | 1/1011 (0.1%) | |
| Gastrointestinal disorders | ||
| Chronic gastritis | 1/1011 (0.1%) | |
| Constipation | 1/1011 (0.1%) | |
| General disorders | ||
| Malaise | 1/1011 (0.1%) | |
| Metabolism and nutrition disorders | ||
| Hypoglycaemia | 1/1011 (0.1%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 1/1011 (0.1%) | |
| Muscular weakness | 1/1011 (0.1%) | |
| Nervous system disorders | ||
| Dizziness | 1/1011 (0.1%) | |
| Renal and urinary disorders | ||
| Renal disorder | 1/1011 (0.1%) | |
| Skin and subcutaneous tissue disorders | ||
| Cold sweat | 1/1011 (0.1%) | |
| Drug eruption | 1/1011 (0.1%) | |
| Rash | 1/1011 (0.1%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Takeda |
| Phone | +1-877-825-3327 |
| trialdisclosures@takeda.com |
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT03555565
Other Study ID Numbers:
- Alogliptin-Met-5003
- JapicCTI-183979
First Posted:
Jun 13, 2018
Last Update Posted:
Nov 23, 2020
Last Verified:
Oct 1, 2020