An Exploratory Study of the Effects of Trelagliptin and A... | NCT02771093 | Trialant
NCT02771093
Sponsor
Takeda
Status
Completed
Last Update Posted
Dec 12, 2023Actual
Enrollment
27Actual
Phase
Phase 4
Conditions
Type 2 Diabetes Mellitus
Interventions
Trelagliptin
Alogliptin
Countries
Japan
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02771093
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
Trelagliptin-4001
Secondary IDs
ID
Type
Description
Link
U1111-1182-4062
Other Identifier
UTN
JapicCTI-163250
Registry Identifier
JapicCTI
Brief Title
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
Official Title
An Exploratory Study to Evaluate the Effects of Trelagliptin and Alogliptin by CGM on Glucose Variability for One Week in Patients With Type 2 Diabetes Mellitus
Acronym
TRACK
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Dec 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 8, 2016Actual
Primary Completion Date
Apr 27, 2017Actual
Completion Date
Apr 27, 2017Actual
First Submitted Date
May 11, 2016
First Submission Date that Met QC Criteria
May 11, 2016
First Posted Date
May 12, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 27, 2018
Results First Submitted that Met QC Criteria
Apr 27, 2018
Results First Posted Date
Dec 10, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 7, 2023
Last Update Posted Date
Dec 12, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TakedaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).
Detailed Description
The purpose of this study is to evaluate the effect of trelagliptin administered orally at a dose of 100 mg once weekly or alogliptin administered orally at a dose of 25 mg once daily for 4 weeks on glycemic variation in an exploratory manner as a primary objective and to evaluate the effect of difference method of administration of Dipeptidyl-peptidase (DPP)-4 on glycemic variation as secondary objective.
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
Type 2, Diabetes, Diabetes Mellitus
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
27Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Trelagliptin 100 mg group
Experimental
Trelagliptin 100 mg once weekly taken orally before breakfast
Drug: Trelagliptin
Alogliptin 25 mg group
Experimental
Alogliptin 25 mg once daily taken orally before breakfast
Drug: Alogliptin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Trelagliptin
Drug
Trelagliptin 100 mg tablet
Trelagliptin 100 mg group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 [Day 22] and Day 8 on Week 3 [Day 28]) of the treatment period, calculated from the value at the start of the observation period.
Baseline, up to 28 days
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (180 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Baseline, up to 28 days
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures.
Participants diagnosed with type 2 diabetes mellitus.
Participants with a glycated hemoglobin (HbA1c) [National Glycohemoglobin Standardization Program (NGSP value)] value ≥ 6.5% and < 8.5% at the start of the observation period (Day -2).
Participants who experience a ≤ ±1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks.
Participants receiving stable dietetic therapy and exercise therapy (if performed) for ≥ 4 weeks before the start of the observation period.
Participants, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period.
Men or women aged 20 years or older at the time of informed consent.
Exclusion Criteria:
Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period.
Participants who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors ≤ 4 weeks before the start of the observation period.
Participants with clinically evident hepatic dysfunction (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5-fold the upper limit of normal at the start of the observation period [Day -2]).
Participants with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance < 50 mL/min or serum creatinine > 1.4 mg/dL in men or > 1.2 mg/dL in women [equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg] at the start of the observation period [Day -2]).
Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases.
Participants with a history of gastric or small intestinal resection.
Participants with proliferative diabetic retinopathy.
Participants warranting insulin therapy for glycemic control (e.g., participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative participants, or serious trauma).
Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2).
Participants with any malignant tumors.
Habitual drinkers whose average daily alcohol consumption is > 100 mL.
Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert.
Participants anticipated to require any prohibited concomitant medications during the study period.
Participants who are day and night lifestyle reversal.
Participants participating in any other clinical studies at the time of informed consent for this study.
Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant.
Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.
Nishimura R, Osonoi T, Koike Y, Miyata K, Shimasaki Y. A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes. Adv Ther. 2019 Nov;36(11):3096-3109. doi: 10.1007/s12325-019-01097-z. Epub 2019 Sep 27.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in 1 of 2 (the trelagliptin 100 mg group or the alogliptin 25 mg group) treatment groups.
Recruitment Details
Participants took part in the study at 2 investigative sites in Japan, from 08 September 2016 to 27 April 2017.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
FG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00013 subjects
FG00114 subjects
COMPLETED
FG00013 subjects
FG00114 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
BG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 [Day 22] and Day 8 on Week 3 [Day 28]) of the treatment period, calculated from the value at the start of the observation period.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Adverse Events Module
Frequency Threshold
0
Time Frame
Up to 29 days
Description
At each visit the investigator had to document any occurrence of adverse events 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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastric mucosal lesion
Gastrointestinal disorders
MedDRA Version 20.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (110 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (140 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (160 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels was less than 70 mg/dL at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in peak postprandial glucose levels during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal
Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
Change from baseline in MAGE at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in Mean 24-hour Blood Glucose Levels
Change from baseline in mean 24-hour blood glucose levels at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in Mean Daytime Blood Glucose Levels
Change from baseline in mean daytime blood glucose levels at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in Mean Nocturnal Blood Glucose Levels
Change from baseline in mean nocturnal blood glucose levels at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose
Change from baseline in AUC for blood glucose levels at each time points was calculated.
Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated.
Baseline, up to 28 days
Standard Deviation (SD) of 24-hour Blood Glucose Values
Baseline, up to 28 days
Changes From Baseline in the SD of Daytime Blood Glucose Values
Change from baseline in SD of daytime blood glucose values at each time points was calculated.
Baseline, up to 28 days
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
Change from baseline in SD of nocturnal blood glucose values at each time points was calculated.
Baseline, up to 28 days
Number of Participants Reporting One or More Treatment-emergent Adverse Events
Up to 29 days
BG002
Total
Total of all reporting groups
13
BG00114
BG00227
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG00062.8± 10.14
BG00162.7± 7.64
BG00262.7± 8.76
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
Female
BG0006
BG0014
BG00210
Male
BG000
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
Title
Measurements
BG0020
Region of Enrollment
Number
Participants
Title
Denominators
Categories
Japan
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG00013
BG00114
BG00227
Height
Mean
Standard Deviation
centimeter (cm)
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG000160.9± 10.40
BG001164.4± 7.17
BG002162.7± 8.87
Weight
Mean
Standard Deviation
kilogram (kg)
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG00066.45± 14.107
BG00164.15± 9.585
BG00265.26± 11.796
Body Mass Index (BMI)
Body Mass Index = weight (kg)/[height (m)^2]
Mean
Standard Deviation
(kg/m^2)
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG00025.45± 2.948
BG00123.65± 2.404
BG00224.52± 2.783
Smoking Classification
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
Never Smoked
BG0008
BG0017
BG00215
Current Smoker
BG000
Alcohol Classification
Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
Yes
BG0001
BG0012
BG0023
No
BG000
Duration of Diabetes Mellitus
Mean duration between start of study and first time of diagnosis of type 2 diabetes mellitus was reported.
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG0005.62± 4.471
BG0016.15± 4.679
BG0025.89± 4.500
Glycated hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]
Mean
Standard Deviation
percent
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG0007.29± 0.616
BG0017.19± 0.339
BG0027.24± 0.485
Mean Amplitude Glycemic Excursions (MAGE)
MAGE is used for a measurement of the degree of glucose level fluctuations, and is the average difference of blood glucose levels exceeds 1 standard deviation (SD) of the average 24-hours blood glucose levels. MAGE was calculated from the data of blood glucose levels every day during continuous glucose monitoring (CGM) in the observation and treatment periods.
The number analyzed is the number of participants with data available for analysis.
Mean
Standard Deviation
millgrams per deciliter (mg/dL)
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00113
ParticipantsBG00226
Title
Measurements
BG00098.02± 44.191
BG001114.91± 38.454
BG002106.47± 41.488
Mean 24-hour Blood Glucose
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG000145.65± 17.570
BG001161.01± 18.349
BG002153.62± 19.287
Area Under the Plasma Concentration-time Curve (AUC) of blood glucose
Mean
Standard Deviation
mg*min/dL
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG00041947.9± 5058.50
BG00146372.7± 5282.47
BG00244242.3± 5553.22
Fasting Insulin
Mean
Standard Deviation
uU/mL
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG0009.42± 4.177
BG0018.79± 4.395
BG0029.09± 4.221
Fasting Blood Glucose
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
ParticipantsBG00013
ParticipantsBG00114
ParticipantsBG00227
Title
Measurements
BG000144.0± 17.57
BG001145.5± 19.15
BG002144.8± 18.06
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
Day(D) 2 Week(W) 3
Title
Measurements
OG000-7.51(-17.10 to 2.08)
OG001-13.04(-20.84 to -5.23)
D3W3
Title
Measurements
OG000-11.76(-21.12 to -2.40)
OG001-15.24(-21.87 to -8.61)
D4W3
Title
Measurements
OG000-11.71(-21.84 to -1.58)
OG001-12.91(-18.55 to -7.26)
D5W3
Title
Measurements
OG000-9.89(-19.83 to 0.05)
OG001-13.28(-21.28 to -5.27)
D6W3
Title
Measurements
OG000-12.75(-22.01 to -3.49)
OG001-11.94(-20.58 to -3.29)
D7W3
Title
Measurements
OG000-9.50(-18.58 to -0.42)
OG001-10.90(-20.00 to -1.80)
D8W3
Title
Measurements
OG000-7.35(-15.13 to 0.44)
OG001-11.63(-18.67 to -4.59)
Secondary
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (180 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3 after breakfast
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG000-90.7(-559.9 to 378.5)
Secondary
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (110 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3 after breakfast
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG000-203.7(-857.5 to 450.1)
Secondary
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (140 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3 after breakfast
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG000-218.5(-811.5 to 374.4)
Secondary
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (160 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3 after breakfast
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG000-164.5(-704.0 to 374.9)
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-1935.9(-4619.7 to 747.9)
OG001-4021.4(-5867.0 to -2175.7)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-1458.0(-3556.4 to 640.4)
OG001-3075.8(-4672.5 to -1479.1)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-989.9(-2508.3 to 528.4)
OG001-2247.9(-3524.3 to -971.6)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
min
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-116.9(-321.9 to 88.1)
OG001-212.5(-326.5 to -98.5)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
min
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-134.2(-315.6 to 47.1)
OG001-229.3(-329.7 to -128.9)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
min
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-91.2(-255.3 to 73.0)
OG001-210.7(-315.9 to -105.6)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels was less than 70 mg/dL at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-31.2(-105.8 to 43.3)
OG0010.4(-0.4 to 1.1)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in peak postprandial glucose levels during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3 after breakfast
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG000-11.3(-45.9 to 23.3)
Secondary
Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal
Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3 between before/after breakfast
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG000-13.9(-51.7 to 23.8)
Secondary
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
Change from baseline in MAGE at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
ParticipantsOG00013
ParticipantsOG00113
Title
Measurements
OG000-28.42(-50.55 to -6.29)
Secondary
Change From Baseline in Mean 24-hour Blood Glucose Levels
Change from baseline in mean 24-hour blood glucose levels at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-8.14(-20.37 to 4.09)
OG001-16.77(-23.33 to -10.21)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in Mean Daytime Blood Glucose Levels
Change from baseline in mean daytime blood glucose levels at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-11.08(-25.75 to 3.58)
OG001-20.38(-28.27 to -12.48)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in Mean Nocturnal Blood Glucose Levels
Change from baseline in mean nocturnal blood glucose levels at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-2.65(-17.20 to 11.89)
OG001-10.69(-23.02 to 1.64)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in AUC for Blood Glucose
Change from baseline in AUC for blood glucose levels at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-2340.4(-5859.6 to 1178.8)
OG001-4828.9(-6716.3 to -2941.6)
D3W3
Title
Measurements
OG000
Secondary
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg·min/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-2263.8(-5522.2 to 994.7)
OG001-4735.1(-6642.5 to -2827.7)
D3W3
Title
Measurements
OG000
Secondary
Standard Deviation (SD) of 24-hour Blood Glucose Values
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
Baseline
Title
Measurements
OG00038.18(27.46 to 48.91)
OG00140.44(34.14 to 46.74)
D2W3
Title
Measurements
OG000
Secondary
Changes From Baseline in the SD of Daytime Blood Glucose Values
Change from baseline in SD of daytime blood glucose values at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-9.78(-19.01 to -0.54)
OG001-13.28(-21.07 to -5.48)
D3W3
Title
Measurements
OG000
Secondary
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
Change from baseline in SD of nocturnal blood glucose values at each time points was calculated.
Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.
Posted
Mean
95% Confidence Interval
mg/dL
Baseline, up to 28 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
D2W3
Title
Measurements
OG000-0.71(-7.36 to 5.95)
OG001-2.45(-13.78 to 8.88)
D3W3
Title
Measurements
OG000
Secondary
Number of Participants Reporting One or More Treatment-emergent Adverse Events
Safety Analysis Set (SAS), SAS was defined as participants who received at least one dose of the study drug.
Posted
Count of Participants
Participants
Up to 29 days
ID
Title
Description
OG000
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
OG001
Alogliptin 25 mg
Alogliptin 25 mg group; Alogliptin 25 mg once daily taken orally before breakfast.
Units
Counts
Participants
OG00013
OG00114
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
0
13
0
13
1
13
EG001
Trelagliptin 100 mg
Trelagliptin 100 mg group; Trelagliptin 100 mg once weekly taken orally before breakfast.
0
14
0
14
2
14
EG0000 affected13 at risk
EG0011 affected14 at risk
Feeling abnormal
General disorders
MedDRA Version 20.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected14 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA Version 20.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected14 at risk
Dizziness
Nervous system disorders
MedDRA Version 20.0
Systematic Assessment
EG0001 affected13 at risk
EG0010 affected14 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Systematic Assessment
EG0000 affected13 at risk
EG0011 affected14 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.