Trial Outcomes & Findings for Phase 3 Alogliptin Pediatric Study (NCT NCT02856113)
NCT ID: NCT02856113
Last Updated: 2022-10-19
Results Overview
Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Week 26 relative to Baseline. Mixed model for repeated measures (MMRM) was used for the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
152 participants
Primary outcome timeframe
Baseline and Week 26
Results posted on
2022-10-19
Participant Flow
A total of 152 participants took part in the study at 67 investigative sites in Mexico, United States, Brazil, Israel, Italy and Russia from 14 October 2016 to 14 February 2022.
Participants with type 2 diabetes mellitus were enrolled to receive placebo or alogliptin 25 mg in a 1:1 ratio in this study.
Participant milestones
| Measure |
Placebo
Alogliptin matching-placebo tablets, orally, once daily (QD) for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
75
|
|
Overall Study
Safety Population
|
76
|
75
|
|
Overall Study
COMPLETED
|
66
|
60
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
Reasons for withdrawal
| Measure |
Placebo
Alogliptin matching-placebo tablets, orally, once daily (QD) for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
1
|
0
|
|
Overall Study
Significant Protocol Deviation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Voluntary Withdrawal
|
3
|
5
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Principal Investigator Discretion
|
2
|
1
|
|
Overall Study
Randomized but not Treated
|
1
|
0
|
|
Overall Study
Did not Complete Study but Contacted at Week 52
|
0
|
3
|
Baseline Characteristics
Phase 3 Alogliptin Pediatric Study
Baseline characteristics by cohort
| Measure |
Placebo
n=76 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=75 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 2.21 • n=5 Participants
|
14.2 years
STANDARD_DEVIATION 1.92 • n=7 Participants
|
14.2 years
STANDARD_DEVIATION 2.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
164.7 centimetres (cm)
STANDARD_DEVIATION 9.54 • n=5 Participants
|
163.1 centimetres (cm)
STANDARD_DEVIATION 8.79 • n=7 Participants
|
163.9 centimetres (cm)
STANDARD_DEVIATION 9.18 • n=5 Participants
|
|
Weight
|
92.23 kilograms (kg)
STANDARD_DEVIATION 26.826 • n=5 Participants
|
90.72 kilograms (kg)
STANDARD_DEVIATION 28.815 • n=7 Participants
|
91.48 kilograms (kg)
STANDARD_DEVIATION 27.749 • n=5 Participants
|
|
Body Mass Index (BMI)
|
33.632 kg/m^2
STANDARD_DEVIATION 7.8581 • n=5 Participants
|
33.669 kg/m^2
STANDARD_DEVIATION 8.6592 • n=7 Participants
|
33.650 kg/m^2
STANDARD_DEVIATION 8.2381 • n=5 Participants
|
|
Baseline of Glycosylated Hemoglobin (HbA1c)
|
8.11 percentage of HbA1c
n=5 Participants
|
8.16 percentage of HbA1c
n=7 Participants
|
8.13 percentage of HbA1c
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: FAS included all randomized participants in the safety set. Overall number of participants analyzed are the number of participants available for analysis.
Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Week 26 relative to Baseline. Mixed model for repeated measures (MMRM) was used for the analysis.
Outcome measures
| Measure |
Placebo
n=56 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=54 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
|
-0.011 percentage of HbA1c
Standard Deviation 0.2809
|
0.091 percentage of HbA1c
Standard Deviation 0.2879
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 18, 39 and 52Population: FAS included all randomized participants in the safety set. Overall number of participants analyzed are the number of participants available for analysis.
Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Weeks 12, 18, 39 and 52 relative to Baseline. MMRM was used for the analysis.
Outcome measures
| Measure |
Placebo
n=62 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=62 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52
Change From Baseline at Week 12
|
-0.319 percentage of HbA1c
Standard Deviation 0.2173
|
-0.365 percentage of HbA1c
Standard Deviation 0.2223
|
|
Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52
Change From Baseline at Week 18
|
-0.206 percentage of HbA1c
Standard Deviation 0.2458
|
-0.202 percentage of HbA1c
Standard Deviation 0.2529
|
|
Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52
Change From Baseline at Week 39
|
0.502 percentage of HbA1c
Standard Deviation 0.2802
|
0.091 percentage of HbA1c
Standard Deviation 0.2866
|
|
Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52
Change From Baseline at Week 52
|
0.764 percentage of HbA1c
Standard Deviation 0.3118
|
0.281 percentage of HbA1c
Standard Deviation 0.3199
|
SECONDARY outcome
Timeframe: From Day 1 to end of treatment period (up to 52 weeks)Population: Safety Set included all participants who took at least 1 dose of study medication. Number analyzed is the number of participants available for analysis at the specific time point. Overall number of participants analyzed are the number of participants available for analysis.
Physical examination included examination of the following body systems: (1) respiratory system; (2) cardiovascular system; (3) nervous system (4) dermatologic system; and (5) gastrointestinal system. A summarized data for the above body systems was reported for participants with clinically significant findings.
Outcome measures
| Measure |
Placebo
n=71 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=71 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Percentage of Participants With Clinically Significant Physical Examination Findings
Week 4
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Clinically Significant Physical Examination Findings
Week 12
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Clinically Significant Physical Examination Findings
Week 18
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Clinically Significant Physical Examination Findings
Week 26
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Clinically Significant Physical Examination Findings
Week 32
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Clinically Significant Physical Examination Findings
Week 39
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Clinically Significant Physical Examination Findings
Week 45
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Clinically Significant Physical Examination Findings
Week 52
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to end of treatment period (up to 52 weeks)Population: Safety Set included all participants who took at least 1 dose of study medication. Number analyzed are the number of participants with data available for analysis for given category. The percentages are rounded off to the next decimal value.
Vital signs included body temperature (oral or tympanic measurement), respiratory rate, blood pressure \[systolic blood pressure (SBP) and diastolic blood pressure (DBP)\] resting more than 5 minutes, and pulse (beats per minute). Data for participants with abnormal vital signs was reported. The percentage of participants are calculated based on the participants with non-missing data at that time-point.
Outcome measures
| Measure |
Placebo
n=76 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=75 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Percentage of Participants With Abnormal Vital Signs Values
SBP (millimeters of mercury [mmHg]): >150
|
1.3 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Abnormal Vital Signs Values
DBP (mmHg): >95
|
4.0 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With Abnormal Vital Signs Values
Pulse Rate (beats per minute [bpm]): <50
|
—
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Vital Signs Values
Pulse Rate (beats per minute [bpm]): >120
|
—
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Vital Signs Values
Temperature (Celsius [C]): <35.6
|
—
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26 and 52Population: Safety Set included all participants who took at least 1 dose of study medication.
Outcome measures
| Measure |
Placebo
n=76 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=75 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Percentage of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Week 26: Abnormal, Not Clinically Significant
|
7 participants
|
6 participants
|
|
Percentage of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Week 26: Abnormal, Clinically Significant
|
2 participants
|
0 participants
|
|
Percentage of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Week 52: Abnormal, Not Clinically Significant
|
7 participants
|
6 participants
|
|
Percentage of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Week 52: Abnormal, Clinically Significant
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From the study start up to end of the study (up to 54 weeks)Population: Safety Set included all participants who took at least 1 dose of study medication.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Placebo
n=76 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=75 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAE)
|
76.3 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to end of treatment period (up to 52 weeks)Population: Safety Set included all participants who took at least 1 dose of study medication. Number analyzed are the number of participants with data available for analysis for given category. The percentages are rounded off to the next decimal value.
The percentage of participants are calculated based on the participants with non-missing data at that time-point.
Outcome measures
| Measure |
Placebo
n=76 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=75 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions
Bladder Infection
|
0.0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions
COVID-19 Infection
|
9.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions
Low Urinary Tract Infection
|
0.0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions
Lower Respiratory Tract Infection
|
9.1 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions
Sinus Infection
|
9.1 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions
Upper Respiratory Infection
|
18.2 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions
Upper Respiratory Tract Infection
|
9.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Total, Urinary and Respiratory Tract Infections and Hypersensitivity Reactions
Lower Urinary Tract Infection
|
9.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to end of treatment period (up to 52 weeks)Population: Safety Set included all participants who took at least 1 dose of study medication.
Mild to moderate hypoglycemia (abnormal low blood sugar) was defined as blood glucose less than (\<) 60 milligram per deciliter (mg/dL) (3.33 millimole per liter \[mmol/L\]) in the presence of symptoms, or blood glucose \<50 mg/dL (2.78 mmol/L) with or without symptoms. Severe hypoglycemia was defined as any episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, associated with a documented blood glucose \<60 mg/dL (3.33 mmol/L) (unless the clinical situation makes obtaining a blood glucose difficult \[example, it involves coma or seizure\]).
Outcome measures
| Measure |
Placebo
n=76 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=75 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Percentage of Participants With Hypoglycemia
|
7.9 percentage of participants
|
5.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to end of treatment period (up to 52 weeks)Population: Safety Set included all participants who took at least 1 dose of study medication. Number analyzed is the number of participants available for analysis at the specific time point. Overall number of participants analyzed are the number of participants available for analysis.
The percentage of participants with any abnormal standard safety laboratory values (hematology, serum chemistry, and urinalysis) were collected throughout study. Abnormal values for hematology included hematocrit (percentage of hematocrit \[%\]), hemoglobin (grams per liter \[g/L\]), erythrocyte mean corpuscular volume (MCV)(femtoliter \[fL\]), erythrocytes (10\^12/L), and leukocytes (10\^9/L). Abnormal values for serum chemistry included for alanine aminotransferase (units per liter \[U/L\]), aspartate aminotransferase (U/L), cholesterol (millimoles per liter \[mmol/L\]), gamma glutamyl transferase (U/L), glucose (mmol/L): \< 2.8 mmol/L, potassium (mmol/L), sodium (mmol/L), and triglycerides (mmol/L). ULN is upper limit of normal and LLN is lower limit of normal.
Outcome measures
| Measure |
Placebo
n=75 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=73 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Alanine Aminotransferase (U/L): >= 3 x ULN
|
10.7 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Aspartate Aminotransferase (U/L): >= 3 x ULN
|
2.7 percentage of participants
|
—
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Cholesterol (mmol/L): >7.72 mmol/L
|
1.3 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Gamma Glutamyl Transferase (U/L): >= 3 x ULN
|
2.7 percentage of participants
|
6.9 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Glucose (mmol/L): < 2.8 mmol/L
|
13.3 percentage of participants
|
20.5 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Glucose (mmol/L): >19.4 mmol/L
|
10.7 percentage of participants
|
13.7 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Potassium (mmol/L): <3.0 mmol/L
|
—
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Phosphate (mmol/L): >2.00 mmol/L
|
—
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Sodium (mmol/L): <130 mmol/L
|
1.3 percentage of participants
|
—
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Triglycerides (mmol/L): >2.5x ULN
|
6.7 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Hematocrit (%): >1.2 x ULN
|
9.5 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Hemoglobin (g/L): < 0.8 x LLN
|
—
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Hemoglobin (g/L): >1.2 x ULN
|
4.1 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Erythrocyte Mean Corpuscular Volume (fL): <70 fL
|
2.7 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Erythrocyte Mean Corpuscular Volume (fL): >100 fL
|
—
|
2.8 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Erythrocytes (10^12/L): >1.2 x ULN
|
1.4 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Abnormal Safety Laboratory Findings
Leukocytes (10^9/L): >1.5 x ULN
|
2.7 percentage of participants
|
2.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26 and 52Population: Safety Set included all participants who took at least 1 dose of study medication. Number analyzed is the number of participants available for analysis at the specific time point. Overall number of participants analyzed are the number of participants available for analysis.
Biomarkers of bone turnover are bone-specific alkaline phosphatase to assess changes in bone formation and C-terminal telopeptide (CTX) to assess changes in bone resorption.
Outcome measures
| Measure |
Placebo
n=67 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=68 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Change From Baseline in Biomarkers of Bone Turnover at Weeks 26 and 52
Baseline
|
62.09 units per liter (U/L)
Standard Deviation 37.084
|
62.62 units per liter (U/L)
Standard Deviation 43.180
|
|
Change From Baseline in Biomarkers of Bone Turnover at Weeks 26 and 52
Change From Baseline at Week 26
|
-6.20 units per liter (U/L)
Standard Deviation 18.021
|
-7.47 units per liter (U/L)
Standard Deviation 20.139
|
|
Change From Baseline in Biomarkers of Bone Turnover at Weeks 26 and 52
Change From Baseline at Week 52
|
-14.36 units per liter (U/L)
Standard Deviation 18.000
|
-15.43 units per liter (U/L)
Standard Deviation 22.497
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26 and 52Population: Safety Set included all participants who took at least 1 dose of study medication. Number analyzed is the number of participants available for analysis at the specific time point. Overall number of participants analyzed are the number of participants available for analysis.
Outcome measures
| Measure |
Placebo
n=57 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=58 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Change From Baseline in CD26 (CD4+T Cells) Surface Antigen Levels at Weeks 26 and 52
Baseline
|
78.2 percentage of CD4+ T cells
Standard Deviation 8.60
|
77.7 percentage of CD4+ T cells
Standard Deviation 7.23
|
|
Change From Baseline in CD26 (CD4+T Cells) Surface Antigen Levels at Weeks 26 and 52
Change From Baseline at Week 26
|
1.2 percentage of CD4+ T cells
Standard Deviation 6.00
|
1.6 percentage of CD4+ T cells
Standard Deviation 7.20
|
|
Change From Baseline in CD26 (CD4+T Cells) Surface Antigen Levels at Weeks 26 and 52
Change From Baseline at Week 52
|
1.0 percentage of CD4+ T cells
Standard Deviation 5.39
|
0.8 percentage of CD4+ T cells
Standard Deviation 4.89
|
SECONDARY outcome
Timeframe: Baseline, Weeks 26 and 52Population: Safety Set included all participants who took at least 1 dose of study medication. Number analyzed is the number of participants available for analysis at the specific time point. Overall number of participants analyzed are the number of participants available for analysis.
Outcome measures
| Measure |
Placebo
n=58 Participants
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=58 Participants
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Change From Baseline in CD26 (CD8+T Cells) Surface Antigen Levels at Weeks 26 and 52
Baseline
|
59.7 percentage of CD8+ T cells
Standard Deviation 13.51
|
59.6 percentage of CD8+ T cells
Standard Deviation 15.30
|
|
Change From Baseline in CD26 (CD8+T Cells) Surface Antigen Levels at Weeks 26 and 52
Change From Baseline at Week 26
|
-0.2 percentage of CD8+ T cells
Standard Deviation 9.15
|
1.7 percentage of CD8+ T cells
Standard Deviation 8.76
|
|
Change From Baseline in CD26 (CD8+T Cells) Surface Antigen Levels at Weeks 26 and 52
Change From Baseline at Week 52
|
1.0 percentage of CD8+ T cells
Standard Deviation 7.63
|
-0.3 percentage of CD8+ T cells
Standard Deviation 10.51
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Alogliptin 25 mg
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=76 participants at risk
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=75 participants at risk
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Nervous system disorders
Brain oedema
|
0.00%
0/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
1.3%
1/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
1.3%
1/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
1.3%
1/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
1.3%
1/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
1.3%
1/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Vascular disorders
Hypertensive urgency
|
1.3%
1/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
1.3%
1/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
1.3%
1/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Lip injury
|
1.3%
1/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Periorbital cellulitis
|
1.3%
1/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
1.3%
1/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
1.3%
1/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=76 participants at risk
Alogliptin matching-placebo tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
Alogliptin 25 mg
n=75 participants at risk
Alogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
7/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
9.3%
7/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
6.7%
5/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Investigations
Glycosylated haemoglobin increased
|
5.3%
4/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
10.5%
8/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
18.7%
14/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.8%
9/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
12.0%
9/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.6%
5/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
9.3%
7/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
5/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Sinusitis
|
5.3%
4/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
6.6%
5/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
0.00%
0/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
5.3%
4/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
6/76 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
5.3%
4/75 • From the study start up to end of the study (up to 54 weeks)
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. Safety Set included all participants who took at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
- Publication restrictions are in place
Restriction type: OTHER