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Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01964950
First received: October 15, 2013
Last updated: February 27, 2017
Last verified: February 2017
Results First Received: August 23, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Surveillance

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 221 investigative sites in Japan from 1-Jul-11 to 31-Dec-14.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with type 2 diabetes mellitus started treatment with alogliptin as per routine clinical practice were observed. As per protocol, participants we enrolled in 1 observational group at the start and were divided into 2 groups based on Sulfonylurea (SU) use for analysis of safety endpoints. Participant data was collected for overall arm.

Reporting Groups
  Description
All Population (Alogliptin) All participants who received alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months along with an SU or without an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.

Participant Flow:   Overall Study
    All Population (Alogliptin)
STARTED   1101 [1] 
COMPLETED   1076 
NOT COMPLETED   25 
Protocol Violation                25 
[1] Data reports overall population,since data not collected separately per arm as specified in protocol



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis set was defined as all participants who completed the study and had safety data available.

Reporting Groups
  Description
Alogliptin + SU Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
Alogliptin + Other Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
Total Total of all reporting groups

Baseline Measures
   Alogliptin + SU   Alogliptin + Other   Total 
Overall Participants Analyzed 
[Units: Participants]
 916   160   1076 
Age, Customized 
[Units: Participants]
     
Less Than (<) 65 Years   380   69   449 
Greater Than or Equal to (>=) 65 Years   536   91   627 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      378  41.3%      52  32.5%      430  40.0% 
Male      538  58.7%      108  67.5%      646  60.0% 
Region of Enrollment 
[Units: Participants]
     
Japan   916   160   1076 
Time From Diagnosis of Type 2 Diabetes 
[Units: Participants]
     
Less than (<)2 years   102   21   123 
Greater than or equal to (>=)2 to <5 years   138   22   160 
>=5 to <10 years   216   25   241 
>=10 years   232   55   287 
Unknown   228   37   265 
Body Mass Index (BMI) 
[Units: Participants]
     
<25 kilogram per square meter (kg/m^2)   326   63   389 
>=25 kg/m^2   318   60   378 
Unknown   272   37   309 
Waist circumference 
[Units: Participants]
     
<85 centimeter (cm) (Male)   52   7   59 
>=85 cm (Male)   102   22   124 
Unknown (Male)   384   79   463 
<90 cm (Female)   52   7   59 
>=90 cm (Female)   39   4   43 
Unknown (Female)   287   41   328 
Pregnancy Status [1] 
[Units: Participants]
     
Not pregnant   378   52   430 
Pregnant   0   0   0 
[1] This baseline characteristic was analyzed only in female participants.
Healthcare Category [1] 
[Units: Participants]
     
Outpatient   891   156   1047 
Inpatient   3   1   4 
Outpatient and Inpatient   22   3   25 
[1] Participants were categorized as outpatient, inpatient, and outpatient and inpatient (participants who were both outpatient and inpatient during some point at the time and 3 months prior to enrollment).
Degree of Renal Dysfunction [1] 
[Units: Participants]
     
Normal   151   25   176 
Mild   351   61   412 
Moderate   146   25   171 
Severe   12   0   12 
Unknown   256   49   305 
[1] Estimated glomerular filtration rate (eGFR) was calculated using variables of gender, age at the start of treatment, and serum creatinine values, and severity was determined based on the following categories. If the serum creatinine value at the start of treatment was not listed, the severity was listed as “unknown.” Normal: >=90 milliliter per minute (mL/min)/1.73^2, Mild: >=60 mL/min/1.73^2 to <90 mL/min/1.73^2 Moderate: >=30 mL/min/1.73^2 to <60 mL/min/1.73^2, Severe: <30 mL/min/1.73^2. eGFR = 194 * Cr^-1.094 * (age)^-0.287 (* 0.739 if female), where Cr is serum creatinine
History of Allergy 
[Units: Participants]
     
Did not have allergy   742   131   873 
Had allergy   78   8   86 
Unknown   96   21   117 
Health-related Complications 
[Units: Participants]
     
Had complications   837   145   982 
Had no complications   79   15   94 
Diabetic Complications 
[Units: Participants]
     
Had complications   187   43   230 
Had no complications   729   117   846 
Breakdown of Diabetic Complications [1] 
[Units: Participants]
     
Diabetic nephropathy   114   23   137 
Diabetic retinopathy   76   21   97 
Diabetic neuropathy   61   20   81 
[1] This baseline characteristic was analyzed only in participants who had diabetic complications. Participants may be represented in more than 1 category.
Complications of Hypertension 
[Units: Participants]
     
Had complications   593   97   690 
Had no complications   323   63   386 
Complications of Dyslipidemia 
[Units: Participants]
     
Had complications   582   99   681 
Had no complications   334   61   395 
Complications of Hyperuricemia 
[Units: Participants]
     
Had complications   74   8   82 
Had no complications   842   152   994 
Complications of Liver Damage 
[Units: Participants]
     
Had complications   181   35   216 
Had no complications   735   125   860 
Breakdown of Complications of Liver Damage [1] 
[Units: Participants]
     
Hepatic steatosis   122   24   146 
Hepatitis alcoholic   30   9   39 
Chronic hepatitis   31   5   36 
Hepatic cirrhosis   2   1   3 
Other   4   0   4 
[1] Liver damage complications were categorized as hepatic steatosis, hepatitis alcoholic, chronic hepatitis, hepatic cirrhosis and any other complications related to liver damage. This baseline characteristic was analyzed only in participants who had complications of liver damage. Participants may be represented in more than 1 category.
Degree of Hepatic Dysfunction [1] 
[Units: Participants]
     
Normal   599   111   710 
Grade 1   75   11   86 
Grade 2   10   2   12 
Unknown   232   36   268 
[1] Severity was determined using aspartate aminotransferase (AST) or alanine transaminase (ALT) values at the start of treatment with alogliptin. For the assessment of severity, the following categories were used and a higher severity grade for either AST or ALT serum levels was adopted. Normal: <50 international units per liter (IU/L), Grade 1: >=50 to <100 IU/L, Grade 2: >=100 to <500 IU/L, and Grade 3: >=500 IU/L.
Complications of Renal Damage 
[Units: Participants]
     
Had complications   126   27   153 
Had no complications   790   133   923 
Breakdown of Complications of Renal Damage [1] 
[Units: Participants]
     
Nephrotic syndrome   3   1   4 
Glomerulonephritis   2   1   3 
Renal failure chronic   9   0   9 
Other   113   25   138 
[1] Renal damage complications were categorized as nephrotic syndrome, glomerulonephritis, renal failure chronic and any other complications related to renal damage. This baseline characteristic was analyzed only in participants who had renal damage complications. Participants may be represented in more than 1 category.
Complications of Heart Disease 
[Units: Participants]
     
Had complications   129   18   147 
Had no complications   787   142   929 
Breakdown of Complications of Heart Disease [1] 
[Units: Participants]
     
Cardiac failure   25   3   28 
Myocardial infarction   26   4   30 
Angina pectoris   70   7   77 
Other   26   4   30 
[1] Heart disease complications were categorized as cardiac failure, myocardial infarction, angina pectoris, and any other complications related to heart disease. This baseline characteristic was analyzed only in participants who had heart disease complications. Participants may be represented in more than 1 category.
Complications of Heart Failure 
[Units: Participants]
     
Had complications   25   3   28 
Had no complications   891   157   1048 
New York Heart Association (NYHA) Heart Failure Classification [1] 
[Units: Participants]
     
NYHA Class I   16   2   18 
NYHA Class II   5   0   5 
NYHA Class III   1   0   1 
NYHA Class IV   1   0   1 
Unknown   2   1   3 
[1] NYHA functional classification ranges from Class I (participants with cardiac disease but without resulting limitations of physical activity), Class II (participants with cardiac disease resulting in slight limitation of physical activity), Class III (participants with cardiac disease resulting in marked limitation of physical activity), Class IV (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). This baseline measure was analyzed only for participants who had complications of heart failure.
Complications of Stroke-related Disease 
[Units: Participants]
     
Had complications   65   7   72 
Had no complications   851   153   1004 
Breakdown of Complications of Stroke-related Disease [1] 
[Units: Participants]
     
Cerebral infarction   64   7   71 
Cerebral haemorrhage   1   0   1 
[1] This baseline characteristic was analyzed only in participants who had complications of stroke-related disease.
Complications of Allergic Disease 
[Units: Participants]
     
Had complications   51   7   58 
Had no complications   865   153   1018 
Complications of Malignant Tumor 
[Units: Participants]
     
Had complications   19   3   22 
Had no complications   897   157   1054 
Presence of Medical History 
[Units: Participants]
     
Had medical history   165   31   196 
Did not have medical history   652   113   765 
Unknown   99   16   115 
History of Alcohol Consumption [1] 
[Units: Participants]
     
Yes   228   44   272 
No   527   84   611 
Unknown   161   32   193 
[1] In this measure, participants responded whether they consumed alcohol-containing beverages nearly every day or not.
Smoking Classification 
[Units: Participants]
     
Never smoked   372   51   423 
Current smoker   145   30   175 
Ex-smoker   189   39   228 
Unknown   210   40   250 
Glycosylated Hemoglobin (HbA1c) Level 
[Units: Participants]
     
HbA1c <6.0 percent (%)   14   4   18 
HbA1c >=6.0% to <7.0%   149   25   174 
HbA1c >=7.0% to <8.0%   312   61   373 
HbA1c >=8.0%   374   61   435 
Unknown   67   9   76 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting One or More Adverse Drug Reactions   [ Time Frame: Baseline up to 12 months ]

2.  Primary:   Number of Participants Reporting One or More Serious Adverse Drug Reaction   [ Time Frame: Baseline up to 12 months ]

3.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12) ]

4.  Secondary:   Percentage of Participants Achieving Objective Glycemic Control   [ Time Frame: Baseline and final assessment (up to Month 12) ]

5.  Secondary:   Change From Baseline in Fasting Blood Glucose   [ Time Frame: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12) ]

6.  Secondary:   Change From Baseline in Fasting Insulin Level   [ Time Frame: Months 1, 3, 6, 12, and final assessment (up to Month 12) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda Pharmaceutical Company Limited
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01964950     History of Changes
Other Study ID Numbers: 121-013
JapicCTI-132266 ( Registry Identifier: JapicCTI )
JapicCTI-R160882 ( Registry Identifier: JapicCTI )
Study First Received: October 15, 2013
Results First Received: August 23, 2016
Last Updated: February 27, 2017