Trial Outcomes & Findings for Randomized Sitagliptin Withdrawal Study (MK-0431-845) (NCT NCT02738879)
NCT ID: NCT02738879
Last Updated: 2019-02-25
Results Overview
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
746 participants
Primary outcome timeframe
Baseline and Week 30
Results posted on
2019-02-25
Participant Flow
A total of 746 participants were randomized across 149 study sites in 22 countries.
Male and female participants with Type 2 diabetes mellitus (T2DM) ≥18 years of age were enrolled in this trial.
Participant milestones
| Measure |
Sitagliptin
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
374
|
372
|
|
Overall Study
Treated
|
373
|
370
|
|
Overall Study
COMPLETED
|
361
|
347
|
|
Overall Study
NOT COMPLETED
|
13
|
25
|
Reasons for withdrawal
| Measure |
Sitagliptin
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Physician Decision
|
3
|
4
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Screen Failure
|
1
|
2
|
|
Overall Study
Site Discontinued Study Participation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
Baseline Characteristics
All randomized and treated participants
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=374 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=372 Participants
Placebo to sitagliptin 100 mg, oral, once daily for 30 weeks
|
Total
n=746 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 9.5 • n=374 Participants
|
58.1 years
STANDARD_DEVIATION 9.7 • n=372 Participants
|
58.3 years
STANDARD_DEVIATION 9.6 • n=746 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=374 Participants
|
0 Participants
n=372 Participants
|
0 Participants
n=746 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=374 Participants
|
0 Participants
n=372 Participants
|
0 Participants
n=746 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=374 Participants
|
0 Participants
n=372 Participants
|
0 Participants
n=746 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=374 Participants
|
0 Participants
n=372 Participants
|
0 Participants
n=746 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=374 Participants
|
0 Participants
n=372 Participants
|
0 Participants
n=746 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=374 Participants
|
0 Participants
n=372 Participants
|
0 Participants
n=746 Participants
|
|
Age, Customized
Adults (18-64 years)
|
275 Participants
n=374 Participants
|
272 Participants
n=372 Participants
|
547 Participants
n=746 Participants
|
|
Age, Customized
From 65-84 years
|
99 Participants
n=374 Participants
|
100 Participants
n=372 Participants
|
199 Participants
n=746 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=374 Participants
|
0 Participants
n=372 Participants
|
0 Participants
n=746 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=374 Participants
|
181 Participants
n=372 Participants
|
385 Participants
n=746 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=374 Participants
|
191 Participants
n=372 Participants
|
361 Participants
n=746 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
19 Participants
n=374 Participants
|
18 Participants
n=372 Participants
|
37 Participants
n=746 Participants
|
|
Race (NIH/OMB)
Asian
|
42 Participants
n=374 Participants
|
37 Participants
n=372 Participants
|
79 Participants
n=746 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=374 Participants
|
1 Participants
n=372 Participants
|
7 Participants
n=746 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=374 Participants
|
12 Participants
n=372 Participants
|
24 Participants
n=746 Participants
|
|
Race (NIH/OMB)
White
|
259 Participants
n=374 Participants
|
270 Participants
n=372 Participants
|
529 Participants
n=746 Participants
|
|
Race (NIH/OMB)
More than one race
|
34 Participants
n=374 Participants
|
34 Participants
n=372 Participants
|
68 Participants
n=746 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=374 Participants
|
0 Participants
n=372 Participants
|
2 Participants
n=746 Participants
|
|
Geographic Region
Asia
|
36 Participants
n=374 Participants
|
26 Participants
n=372 Participants
|
62 Participants
n=746 Participants
|
|
Geographic Region
Europe
|
158 Participants
n=374 Participants
|
172 Participants
n=372 Participants
|
330 Participants
n=746 Participants
|
|
Geographic Region
Latin America
|
85 Participants
n=374 Participants
|
83 Participants
n=372 Participants
|
168 Participants
n=746 Participants
|
|
Geographic Region
North America
|
80 Participants
n=374 Participants
|
78 Participants
n=372 Participants
|
158 Participants
n=746 Participants
|
|
Geographic Region
Other
|
15 Participants
n=374 Participants
|
13 Participants
n=372 Participants
|
28 Participants
n=746 Participants
|
|
Hemoglobin A1C (A1C)
|
8.8 Percent A1C
STANDARD_DEVIATION 0.9 • n=373 Participants • All randomized and treated participants
|
8.8 Percent A1C
STANDARD_DEVIATION 1.0 • n=370 Participants • All randomized and treated participants
|
8.8 Percent A1C
STANDARD_DEVIATION 0.9 • n=743 Participants • All randomized and treated participants
|
|
Fasting Plasma Glucose (FPG)
|
199.0 mg/dL
STANDARD_DEVIATION 50.8 • n=373 Participants • All randomized and treated participants
|
201.2 mg/dL
STANDARD_DEVIATION 51.8 • n=370 Participants • All randomized and treated participants
|
200.1 mg/dL
STANDARD_DEVIATION 51.3 • n=743 Participants • All randomized and treated participants
|
|
Estimated Glomerular Filtration Rate
|
103.7 mL/min/1.73 m^2
STANDARD_DEVIATION 30.3 • n=373 Participants • All randomized and treated participants
|
106.4 mL/min/1.73 m^2
STANDARD_DEVIATION 28.1 • n=370 Participants • All randomized and treated participants
|
105.1 mL/min/1.73 m^2
STANDARD_DEVIATION 29.2 • n=743 Participants • All randomized and treated participants
|
|
Body Weight
|
84.8 Kilograms
STANDARD_DEVIATION 19.8 • n=373 Participants • All randomized and treated participants
|
85.6 Kilograms
STANDARD_DEVIATION 18.9 • n=370 Participants • All randomized and treated participants
|
85.2 Kilograms
STANDARD_DEVIATION 19.4 • n=743 Participants • All randomized and treated participants
|
|
Anti-Hyperglycemic Agent
Met + DPP-4i
|
184 Participants
n=374 Participants
|
184 Participants
n=372 Participants
|
368 Participants
n=746 Participants
|
|
Anti-Hyperglycemic Agent
Met + DPP-4i + sulfonylurea (SU)
|
87 Participants
n=374 Participants
|
86 Participants
n=372 Participants
|
173 Participants
n=746 Participants
|
|
Anti-Hyperglycemic Agent
Met + SU
|
103 Participants
n=374 Participants
|
102 Participants
n=372 Participants
|
205 Participants
n=746 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 30Population: All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline).
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C.
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Change From Baseline in A1C at Week 30
|
-1.88 Percent A1C
95% Confidence Interval -1.98 • Interval -1.98 to -1.78
|
-1.42 Percent A1C
95% Confidence Interval -1.52 • Interval -1.52 to -1.32
|
PRIMARY outcome
Timeframe: Up to 30 weeksPopulation: All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race).
Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.
Outcome measures
| Measure |
Sitagliptin
n=371 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)
|
1.55 Events/Participant-Years
95% Confidence Interval 1.22 • Interval 1.22 to 1.96
|
2.12 Events/Participant-Years
95% Confidence Interval 1.70 • Interval 1.7 to 2.66
|
PRIMARY outcome
Timeframe: Up to 30 weeksPopulation: All randomized participants who received at least one dose of study treatment.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an AE
|
1.3 Percentage of participants
|
1.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 32 weeksPopulation: All randomized participants who received at least one dose of study treatment.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
|
57.9 Percentage of participants
|
60.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 weeksPopulation: All randomized participants who received at least one dose of study treatment.
Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined.
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)
|
33.5 Percentage of participants
95% Confidence Interval 28.5 • Interval 28.5 to 38.6
|
37.7 Percentage of participants
95% Confidence Interval 32.7 • Interval 32.7 to 42.6
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline).
Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline.
Outcome measures
| Measure |
Sitagliptin
n=365 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=367 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Change From Baseline in Total Daily Insulin Dose (Units) at Week 30
|
53.2 Insulin Units
95% Confidence Interval 48.5 • Interval 48.5 to 58.0
|
61.3 Insulin Units
95% Confidence Interval 56.5 • Interval 56.5 to 66.0
|
SECONDARY outcome
Timeframe: Up to 30 weeksPopulation: All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race).
Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.
Outcome measures
| Measure |
Sitagliptin
n=371 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)
|
5.05 Events/Participant-Years
95% Confidence Interval 4.34 • Interval 4.34 to 5.88
|
6.21 Events/Participant-Years
95% Confidence Interval 5.33 • Interval 5.33 to 7.24
|
SECONDARY outcome
Timeframe: Up to 30 weeksPopulation: All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race).
Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.
Outcome measures
| Measure |
Sitagliptin
n=371 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)
|
0.30 Events/Participant-Years
95% Confidence Interval 0.20 • Interval 0.2 to 0.45
|
0.36 Events/Participant-Years
95% Confidence Interval 0.25 • Interval 0.25 to 0.53
|
SECONDARY outcome
Timeframe: Up to 30 weeksPopulation: All randomized participants who received at least one dose of study treatment.
Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L).
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)
|
12.4 Percentage of participants
95% Confidence Interval 8.9 • Interval 8.9 to 15.8
|
13.6 Percentage of participants
95% Confidence Interval 10.0 • Interval 10.0 to 17.2
|
SECONDARY outcome
Timeframe: Week 30Population: All randomized participants who received at least one dose of study treatment.
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30
|
54.2 Percentage of participants
|
35.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 30Population: All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline).
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at Week 0).
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30
|
-84.8 mg/dL
95% Confidence Interval -90.0 • Interval -90.0 to -79.6
|
-78.3 mg/dL
95% Confidence Interval -83.5 • Interval -83.5 to -73.1
|
SECONDARY outcome
Timeframe: Up to 30 weeksPopulation: All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race).
Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.
Outcome measures
| Measure |
Sitagliptin
n=371 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)
|
0.17 Events/Participant-Years
95% Confidence Interval 0.10 • Interval 0.1 to 0.28
|
0.22 Events/Participant-Years
95% Confidence Interval 0.14 • Interval 0.14 to 0.36
|
SECONDARY outcome
Timeframe: Up to 30 weeksPopulation: All randomized participants who received at least one dose of study treatment.
Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L).
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Percentage of Participants With Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)
|
66.8 Percentage of participants
95% Confidence Interval 61.9 • Interval 61.9 to 71.7
|
68.0 Percentage of participants
95% Confidence Interval 63.2 • Interval 63.2 to 72.9
|
SECONDARY outcome
Timeframe: Up to 30 weeksPopulation: All randomized participants who received at least one dose of study treatment.
Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration \<56 mg/dL (≤3.1 mmol/L).
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)
|
7.6 Percentage of participants
95% Confidence Interval 4.9 • Interval 4.9 to 10.3
|
8.3 Percentage of participants
95% Confidence Interval 5.4 • Interval 5.4 to 11.2
|
SECONDARY outcome
Timeframe: Week 30Population: All randomized participants who received at least one dose of study treatment.
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Outcome measures
| Measure |
Sitagliptin
n=373 Participants
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 Participants
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) up to Week 30
|
15.3 Percentage of participants
|
10.0 Percentage of participants
|
Adverse Events
Sitagliptin
Serious events: 14 serious events
Other events: 79 other events
Deaths: 0 deaths
Placebo
Serious events: 18 serious events
Other events: 72 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Sitagliptin
n=373 participants at risk
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 participants at risk
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Cardiac disorders
Coronary artery disease
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Infections and infestations
Gastroenteritis
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Infections and infestations
Groin abscess
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Infections and infestations
Sialoadenitis
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Investigations
Heart rate irregular
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.54%
2/370 • Number of events 2 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.54%
2/370 • Number of events 2 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Nervous system disorders
Sciatica
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.27%
1/373 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.00%
0/370 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/373 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
0.27%
1/370 • Number of events 1 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
Other adverse events
| Measure |
Sitagliptin
n=373 participants at risk
Sitagliptin 100 mg, oral, once daily for 30 weeks
|
Placebo
n=370 participants at risk
Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.4%
24/373 • Number of events 30 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
8.6%
32/370 • Number of events 35 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.4%
35/373 • Number of events 96 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
6.5%
24/370 • Number of events 74 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
|
Nervous system disorders
Headache
|
6.7%
25/373 • Number of events 36 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
5.1%
19/370 • Number of events 23 • Up to 32 weeks
The analysis population consisted all randomized participants who received at least one dose of study treatment. Events of hypoglycemia of any type were collected as efficacy endpoints in this study. AEs of symptomatic hypoglycemia could also be reported by investigators.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER