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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01964976
First Posted: October 17, 2013
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
Results First Submitted: August 31, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Surveillance

  Participant Flow
  Hide Participant Flow

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 207 investigative sites in Japan from 01 July 2011 to 31 December 2014.

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 were enrolled in 1 observational group at the start and were divided into 2 groups based on biguanide use for analysis of safety endpoints. Participant flow data was collected for overall arm.

Reporting Groups
  Description
All Population All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide 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
STARTED   1096 [1] 
COMPLETED   1065 
NOT COMPLETED   31 
Protocol Violation                31 
[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 + Biguanides Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide 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 a biguanide 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 + Biguanides   Alogliptin + Other   Total 
Overall Participants Analyzed 
[Units: Participants]
 954   109   1063 
Age, Customized 
[Units: Participants]
     
Less than (<) 65 years   539   68   607 
Greater than or equal to (>=) 65 years   415   41   456 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      388  40.7%      37  33.9%      425  40.0% 
Male      566  59.3%      72  66.1%      638  60.0% 
Time from Diagnosis of Type 2 Diabetes 
[Units: Participants]
     
<2 years   114   16   130 
>=2 to <5 years   169   20   189 
>=5 to <10 years   218   19   237 
>=10 years   254   27   281 
Unknown   199   27   226 
Body Mass Index 
[Units: Participants]
     
<25 kilogram per square meter (kg/m^2)   345   35   380 
>=25 kg/m^2   410   45   455 
Unknown   199   29   228 
Waist Circumference 
[Units: Participants]
     
<85 centimeter (cm) (Male)   25   5   30 
>=85 cm (Male)   90   4   94 
Unknown (Male)   451   63   514 
<90 cm (Female)   37   4   41 
>=90 cm (Female)   33   3   36 
Unknown (Female)   318   30   348 
Pregnancy Status [1] 
[Units: Participants]
     
Not pregnant   388   37   425 
Pregnant   0   0   0 
[1] This baseline characteristic was analyzed only in female participants.
Healthcare Category [1] 
[Units: Participants]
     
Outpatient   920   102   1022 
Inpatient   2   1   3 
Outpatient and inpatient   32   6   38 
[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   213   12   225 
Mild   359   50   409 
Moderate   135   13   148 
Severe   3   0   3 
Unknown   244   34   278 
[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]
     
Had allergy   773   84   857 
Did not have allergy   92   10   102 
Unknown   89   15   104 
Health-related Complications 
[Units: Participants]
     
Had complications   862   91   953 
Had no complications   92   18   110 
Diabetic complications 
[Units: Participants]
     
Had complications   206   20   226 
Had No Complications   748   89   837 
Breakdown of diabetic complications [1] 
[Units: Participants]
     
Diabetic nephropathy   110   12   122 
Diabetic retinopathy   91   10   101 
Diabetic neuropathy   83   8   91 
[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   567   54   621 
Had no complications   387   55   442 
Complications of Dyslipidemia 
[Units: Participants]
     
Had complications   623   69   692 
Had no complications   331   40   371 
Complications of Hyperuricemia 
[Units: Participants]
     
Had complications   69   14   83 
Had no complications   885   95   980 
Complications of Liver Damage 
[Units: Participants]
     
Had complications   203   20   223 
Had no complications   751   89   840 
Breakdown of Complications of Liver Damage [1] 
[Units: Participants]
     
Hepatic steatosis   158   15   173 
Hepatitis alcoholic   23   5   28 
Chronic hepatitis   15   5   20 
Hepatic cirrhosis   2   1   3 
Other   7   0   7 
[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   597   65   662 
Grade 1   81   13   94 
Grade 2   21   1   22 
Unknown   255   30   285 
[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   114   12   126 
Had No Complications   840   97   937 
Breakdown of Complications of Renal Damage [1] 
[Units: Participants]
     
Nephrotic syndrome   1   0   1 
Glomerulonephritis   1   0   1 
Renal failure chronic   2   0   2 
Other   110   12   122 
[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   103   7   110 
Had no complications   851   102   953 
Breakdown of Complications of Heart Disease [1] 
[Units: Participants]
     
Cardiac failure   19   1   20 
Myocardial infarction   24   1   25 
Angina pectoris   49   3   52 
Other   24   2   26 
[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   19   1   20 
Had no complications   935   108   1043 
New York Heart Association (NYHA) Heart Failure Classification [1] 
[Units: Participants]
     
NYHA Class I   13   0   13 
NYHA Class II   5   0   5 
NYHA Class IV   1   1   2 
[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   58   5   63 
Had no complications   896   104   1000 
Breakdown of Complications of Stroke-related Disease [1] 
[Units: Participants]
     
Cerebral infarction   57   5   62 
Cerebral hemorrhage   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   66   7   73 
Had no complications   888   102   990 
Complications of Malignant Tumor 
[Units: Participants]
     
Had complications   18   6   24 
Had no complications   936   103   1039 
Other Complications [1] 
[Units: Participants]
     
Had complications   315   38   353 
Had no complications   639   71   710 
[1] Participants who had complications other than diabetic, hypertension, dyslipidemia, hyperuricemia, liver damage, renal damage, heart disease, heart failure, stroke-related disease, allergic disease, and malignant tumor were analyzed in this measure.
Presence of Medical History 
[Units: Participants]
     
Had medical history   150   30   180 
Did not have medical history   694   68   762 
Unknown   110   11   121 
History of Alcohol Consumption [1] 
[Units: Participants]
     
Yes   231   26   257 
No   573   60   633 
Unknown   150   23   173 
[1] In this measure, participants responded whether they consumed alcohol-containing beverages nearly every day or not.
Smoking Classification 
[Units: Participants]
     
Never Smoked   442   45   487 
Current Smoker   167   18   185 
Ex-smoker   162   15   177 
Unknown   183   31   214 
Glycosylated Hemoglobin (HbA1c) Level 
[Units: Participants]
     
HbA1c <6.0 percent (%)   12   5   17 
HbA1c >=6.0% to <7.0%   177   16   193 
HbA1c >=7.0% to <8.0%   381   43   424 
HbA1c >=8.0%   341   35   376 
Unknown   43   10   53 


  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 Reactions   [ 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 of 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: Baseline, 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
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01964976     History of Changes
Other Study ID Numbers: 121-014
JapicCTI-132282 ( Registry Identifier: JapicCTI )
JapicCTI-R150790 ( Registry Identifier: JapicCTI )
First Submitted: October 15, 2013
First Posted: October 17, 2013
Results First Submitted: August 31, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017