Trial Outcomes & Findings for Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1) (NCT NCT00509262)
NCT ID: NCT00509262
Last Updated: 2017-05-12
Results Overview
A1C represents percentage of glycosylated hemoglobin.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
426 participants
Primary outcome timeframe
Baseline to Week 54
Results posted on
2017-05-12
Participant Flow
One site was identified as non-compliant with some of the requirements of Good Clinical Practice. For this reason, data from the 3 participants randomized at this site were deemed unreliable and were removed from all analyses.
Participant milestones
| Measure |
Sitagliptin
Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
|
Glipizide
Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
212
|
|
Overall Study
COMPLETED
|
164
|
170
|
|
Overall Study
NOT COMPLETED
|
47
|
42
|
Reasons for withdrawal
| Measure |
Sitagliptin
Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
|
Glipizide
Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
18
|
|
Overall Study
Other
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
24
|
11
|
Baseline Characteristics
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=211 Participants
Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
|
Glipizide
n=212 Participants
Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
|
Total
n=423 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 54Population: The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance \<75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.
A1C represents percentage of glycosylated hemoglobin.
Outcome measures
| Measure |
Sitagliptin
n=135 Participants
Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
|
Glipizide
n=142 Participants
Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
Baseline
|
7.76 Percent of glycosylated hemoglobin
Standard Deviation 0.65 • Interval -0.89 to -0.62
|
7.79 Percent of glycosylated hemoglobin
Standard Deviation 0.70 • Interval -0.64 to -0.51
|
|
Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
Change from Baseline at Week 54
|
-0.70 Percent of glycosylated hemoglobin
Standard Deviation 0.80
|
-0.62 Percent of glycosylated hemoglobin
Standard Deviation 0.91
|
PRIMARY outcome
Timeframe: Baseline up to 28 days following the last dose of study therapyPopulation: All participants as treated (APaT) population included all randomized participants who took at least one dose of study therapy.
Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.
Outcome measures
| Measure |
Sitagliptin
n=210 Participants
Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
|
Glipizide
n=212 Participants
Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
|
|---|---|---|
|
Percentage of Participants With Hypoglycemic Events
|
6.2 percentage of participants
|
17.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 54Population: The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance \<75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.
Outcome measures
| Measure |
Sitagliptin
n=136 Participants
Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
|
Glipizide
n=142 Participants
Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
Baseline
|
148.6 mg/dL
Standard Deviation 39.9
|
143.9 mg/dL
Standard Deviation 35.7
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
Change from Baseline at Week 54
|
-16.7 mg/dL
Standard Deviation 47.1
|
-20.2 mg/dL
Standard Deviation 48.6
|
SECONDARY outcome
Timeframe: Baseline to Week 54Population: All participants as treated (APaT) population included participants who had both baseline and Week 54 data (excluding data after initiation of glycemic rescue therapy).
Outcome measures
| Measure |
Sitagliptin
n=143 Participants
Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
|
Glipizide
n=148 Participants
Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 54
|
-0.6 kg
Standard Error 0.3
|
1.2 kg
Standard Error 0.3
|
Adverse Events
Sitagliptin
Serious events: 36 serious events
Other events: 69 other events
Deaths: 0 deaths
Glipizide
Serious events: 38 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin
n=210 participants at risk
Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
|
Glipizide
n=212 participants at risk
Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.94%
2/212 • Number of events 2
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.94%
2/212 • Number of events 3
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
1.4%
3/212 • Number of events 3
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Coronary artery disease
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Myocardial infarction
|
0.95%
2/210 • Number of events 2
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Eye disorders
Diabetic retinopathy
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Gastrointestinal disorders
Colitis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Gastrointestinal disorders
Uraemic gastropathy
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
General disorders
Asthenia
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
General disorders
Death
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
General disorders
Sudden death
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Gangrene
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Localised infection
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Lung abscess
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Sepsis
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Urinary tract infection
|
1.4%
3/210 • Number of events 3
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Viral infection
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.48%
1/210 • Number of events 2
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
1.9%
4/212 • Number of events 5
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.95%
2/210 • Number of events 2
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Psychiatric disorders
Acute psychosis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Psychiatric disorders
Depression
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Renal and urinary disorders
Azotaemia
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Renal and urinary disorders
Renal failure acute
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.94%
2/212 • Number of events 3
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Renal and urinary disorders
Renal failure chronic
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.94%
2/212 • Number of events 3
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.95%
2/210 • Number of events 2
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.48%
1/210 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.00%
0/212
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Vascular disorders
Haematoma
|
0.00%
0/210
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
0.47%
1/212 • Number of events 1
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
Other adverse events
| Measure |
Sitagliptin
n=210 participants at risk
Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
|
Glipizide
n=212 participants at risk
Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
11/210 • Number of events 14
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
5.7%
12/212 • Number of events 13
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
General disorders
Oedema peripheral
|
7.1%
15/210 • Number of events 17
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
4.7%
10/212 • Number of events 11
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
10/210 • Number of events 15
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
7.1%
15/212 • Number of events 19
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Infections and infestations
Urinary tract infection
|
5.2%
11/210 • Number of events 13
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
9.4%
20/212 • Number of events 31
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Investigations
Blood glucose decreased
|
7.1%
15/210 • Number of events 29
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
15.1%
32/212 • Number of events 159
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.7%
12/210 • Number of events 21
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
16.5%
35/212 • Number of events 89
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Nervous system disorders
Dizziness
|
3.3%
7/210 • Number of events 7
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
5.2%
11/212 • Number of events 12
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
|
Vascular disorders
Hypertension
|
5.2%
11/210 • Number of events 11
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
2.8%
6/212 • Number of events 6
One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
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 study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER