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Trial record 55 of 948 for:    tablet | Japan

Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

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.
 
ClinicalTrials.gov Identifier: NCT01964963
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Type 2 Diabetes Mellitus
Intervention Drug: Alogliptin
Enrollment 19192
Recruitment Details Participants took part in the study at 1406 investigative sites in Japan, from 03 August 2011 to 31 July 2017.
Pre-assignment Details Participants with a historical diagnosis of mild type 2 diabetes mellitus were enrolled. Participants received interventions as part of routine medical care.
Arm/Group Title Alogliptin 25 mg
Hide Arm/Group Description Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Period Title: Overall Study
Started 19192
Completed 18254
Not Completed 938
Reason Not Completed
Case Report Forms Uncollected             888
Protocol Deviation             50
Arm/Group Title Alogliptin 25 mg
Hide Arm/Group Description Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Overall Number of Baseline Participants 18254
Hide Baseline Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18254 participants
67.3  (11.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Female
7973
  43.7%
Male
10281
  56.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 18254 participants
18254
Number of Females who were not Pregnant   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7973 participants
7973
 100.0%
[1]
Measure Analysis Population Description: This baseline characteristic was analyzed only in female participants.
Duration of Diagnosis of Type 2 Diabetes Mellitus   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13943 participants
6.03  (6.452)
[1]
Measure Description: Mean duration between start of study and first time of diagnosis of type 2 diabetes mellitus was reported.
[2]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 15144 participants
159.6  (9.61)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 13078 participants
63.85  (13.325)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
BMI   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kg/meter (m)^2
Number Analyzed 12383 participants
24.95  (4.068)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
[2]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Healthcare Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Outpatient
18074
  99.0%
Inpatient
180
   1.0%
[1]
Measure Description: Participants were categorized as outpatient and inpatient.
Degree of Renal Dysfunction   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Normal
14812
  81.1%
Mild
2767
  15.2%
Moderate
598
   3.3%
Severe
77
   0.4%
[1]
Measure Description: Degree of renal dysfunction was determined by investigator for each participant.
Medical Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Presence of Medical Complications
2323
  12.7%
Had Presence of Medical Complications
15931
  87.3%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
Concomitant Diabetes Mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Diabetes Mellitus
16170
  88.6%
Had Concomitant Diabetes Mellitus
2084
  11.4%
Concomitant Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Hypertension
6765
  37.1%
Had Concomitant Hypertension
11489
  62.9%
Concomitant Hyperlipidemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Hyperlipidemia
7307
  40.0%
Had Concomitant Hyperlipidemia
10947
  60.0%
Concomitant Hyperuricaemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Hyperuricaemia
16619
  91.0%
Had Concomitant Hyperuricaemia
1635
   9.0%
Concomitant Hepatic Disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Hepatic Disorder
16271
  89.1%
Had Concomitant Hepatic Disorder
1983
  10.9%
Concomitant Renal Disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Renal Disorder
16577
  90.8%
Had Concomitant Renal Disorder
1677
   9.2%
Concomitant Cardiac Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Cardiac Disease
16036
  87.8%
Had Concomitant Cardiac Disease
2218
  12.2%
Concomitant Heart Failure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Heart Failure
17714
  97.0%
Had Concomitant Heart Failure
540
   3.0%
New York Heart Association (NYHA) Heart Failure Classification   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants
Class I
354
  65.6%
Class II
143
  26.5%
Class III
26
   4.8%
Class IV
7
   1.3%
Unknown
10
   1.9%
[1]
Measure Description: 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).
[2]
Measure Analysis Population Description: This baseline characteristic was analyzed only for participants who had complications of heart failure.
Concomitant Stroke-Related Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Stroke-Related Disease
17077
  93.6%
Had Concomitant Stroke-Related Disease
1177
   6.4%
Concomitant Allergic Condition  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Allergic Condition
17229
  94.4%
Had Concomitant Allergic Condition
1025
   5.6%
Concomitant Malignant Tumor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Concomitant Malignant Tumor
17837
  97.7%
Had Concomitant Malignant Tumor
417
   2.3%
Medical History   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Medical History
14501
  79.4%
Had Medical History
2081
  11.4%
Unknown
1672
   9.2%
[1]
Measure Description: Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.
Predisposition to Hypersensitivity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Had No Predisposition to Hypersensitivity
15556
  85.2%
Had Predisposition to Hypersensitivity
795
   4.4%
Unknown
1903
  10.4%
[1]
Measure Description: The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.
Drinking Habits   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Yes
5443
  29.8%
No
9158
  50.2%
Unknown
3653
  20.0%
[1]
Measure Description: Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported.
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Never Smoked
8092
  44.3%
Current Smoker
2332
  12.8%
Ex-Smoker
3326
  18.2%
Unknown
4504
  24.7%
Hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP) Value]   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 17879 participants
6.88  (0.591)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Dietary Instruction   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Instructed
15438
  84.6%
Not Instructed
2816
  15.4%
[1]
Measure Description: Reported data was number of participants who received dietary instruction from health care professional at the start of this study as routine medical care.
Exercise Instruction   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18254 participants
Instructed
13914
  76.2%
Not Instructed
4340
  23.8%
[1]
Measure Description: Reported data was number of participants who received exercise instruction from health care professional at the start of this study as routine medical care.
1.Primary Outcome
Title Percentage of Participants Who Had One or More Adverse Events
Hide Description [Not Specified]
Time Frame Up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Arm/Group Title Alogliptin 25 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 18254
Measure Type: Number
Unit of Measure: Percentage of Participants
10.54
2.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Hide 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 36) relative to baseline.
Time Frame Baseline, and final assessment point (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Alogliptin 25 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 16026
Mean (Standard Deviation)
Unit of Measure: Percent HbA1c
-0.14  (0.777)
3.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose
Hide Description The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline.
Time Frame Baseline, and final assessment point (up to Month 36)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Alogliptin 25 mg
Hide Arm/Group Description:
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 6032
Mean (Standard Deviation)
Unit of Measure: Milligram (mg)/ deciliter (dL)
-5.8  (34.33)
Time Frame Up to Month 36
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator’s opinion of causal relationship to the study treatment..
 
Arm/Group Title Alogliptin 25 mg
Hide Arm/Group Description Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
All-Cause Mortality
Alogliptin 25 mg
Affected / at Risk (%)
Total   20/18254 (0.11%) 
Show Serious Adverse Events Hide Serious Adverse Events
Alogliptin 25 mg
Affected / at Risk (%)
Total   65/18254 (0.36%) 
Cardiac disorders   
Acute myocardial infarction  1  1/18254 (0.01%) 
Cardiac failure  1  1/18254 (0.01%) 
Cardiac failure acute  1  2/18254 (0.01%) 
Cardiac failure congestive  1  1/18254 (0.01%) 
Ventricular tachycardia  1  1/18254 (0.01%) 
Gastrointestinal disorders   
Anal fistula  1  1/18254 (0.01%) 
Pancreatitis acute  1  3/18254 (0.02%) 
General disorders   
Death  1 [1]  3/18254 (0.02%) 
Pyrexia  1  1/18254 (0.01%) 
Sudden death  1 [1]  5/18254 (0.03%) 
Hepatobiliary disorders   
Cholangitis  1  1/18254 (0.01%) 
Infections and infestations   
Peritonitis  1  1/18254 (0.01%) 
Pneumonia  1  2/18254 (0.01%) 
Injury, poisoning and procedural complications   
Fall  1  1/18254 (0.01%) 
Subdural haematoma  1  2/18254 (0.01%) 
Excoriation  1  1/18254 (0.01%) 
Contusion  1  1/18254 (0.01%) 
Investigations   
C-reactive protein increased  1  1/18254 (0.01%) 
White blood cell count increased  1  1/18254 (0.01%) 
Metabolism and nutrition disorders   
Cachexia  1  1/18254 (0.01%) 
Hypoglycaemia  1  2/18254 (0.01%) 
Marasmus  1  1/18254 (0.01%) 
Musculoskeletal and connective tissue disorders   
Rhabdomyolysis  1  1/18254 (0.01%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bile duct cancer  1  1/18254 (0.01%) 
Bladder cancer  1  1/18254 (0.01%) 
Bladder neoplasm  1  1/18254 (0.01%) 
Colon cancer  1  2/18254 (0.01%) 
Diffuse large B-cell lymphoma  1  1/18254 (0.01%) 
Gastric cancer  1  1/18254 (0.01%) 
Neoplasm malignant  1  1/18254 (0.01%) 
Oesophageal carcinoma  1  1/18254 (0.01%) 
Ovarian cancer  1  1/18254 (0.01%) 
Pancreatic carcinoma  1  2/18254 (0.01%) 
Lung neoplasm malignant  1  1/18254 (0.01%) 
Intraductal papillary mucinous neoplasm  1  1/18254 (0.01%) 
Hepatic cancer  1  1/18254 (0.01%) 
Hepatic cancer recurrent  1  1/18254 (0.01%) 
Hepatocellular carcinoma  1  1/18254 (0.01%) 
Nervous system disorders   
Cerebellar haemorrhage  1  1/18254 (0.01%) 
Cerebral infarction  1  2/18254 (0.01%) 
Cerebrovascular accident  1  2/18254 (0.01%) 
Epilepsy  1  1/18254 (0.01%) 
Headache  1  1/18254 (0.01%) 
Subdural hygroma  1  1/18254 (0.01%) 
Psychiatric disorders   
Completed suicide  1 [1]  1/18254 (0.01%) 
Depression  1  1/18254 (0.01%) 
Renal and urinary disorders   
Diabetic nephropathy  1  2/18254 (0.01%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary oedema  1  1/18254 (0.01%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
[1]
The reasons of events are not determined because assessment findings were insufficient to specify the reason.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.2%
Alogliptin 25 mg
Affected / at Risk (%)
Total   41/18254 (0.22%) 
Metabolism and nutrition disorders   
Hypoglycaemia  1  41/18254 (0.22%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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 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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01964963     History of Changes
Other Study ID Numbers: 121-015
JapicCTI-132283 ( Registry Identifier: JapicCTI (Japan) )
First Submitted: October 15, 2013
First Posted: October 17, 2013
Results First Submitted: July 27, 2018
Results First Posted: May 9, 2019
Last Update Posted: May 9, 2019