Trial Outcomes & Findings for An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024) (NCT NCT00094770)
NCT ID: NCT00094770
Last Updated: 2016-08-26
Results Overview
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1172 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2016-08-26
Participant Flow
Phase III First Patient In: 26-Oct-2004; Last Patient Last Visit: 17-May-2007; 173 medical clinics worldwide.
Participants 18-78 years of age with type 2 diabetes mellitus (T2DM) and inadequate glycemic control (Hemoglobin A1c \>6.5% and \< 10%) on metformin at a dose of \>1500mg/day.
Participant milestones
| Measure |
Sitagliptin 100 mg
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Year 1 ( Week 0 to Week 52)
STARTED
|
588
|
584
|
|
Year 1 ( Week 0 to Week 52)
COMPLETED
|
386
|
412
|
|
Year 1 ( Week 0 to Week 52)
NOT COMPLETED
|
202
|
172
|
|
Year 2 (Week 0 to Week 104)
STARTED
|
588
|
584
|
|
Year 2 (Week 0 to Week 104)
COMPLETED
|
255
|
264
|
|
Year 2 (Week 0 to Week 104)
NOT COMPLETED
|
333
|
320
|
Reasons for withdrawal
| Measure |
Sitagliptin 100 mg
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Year 1 ( Week 0 to Week 52)
Adverse Event
|
25
|
26
|
|
Year 1 ( Week 0 to Week 52)
Lack of Efficacy
|
86
|
58
|
|
Year 1 ( Week 0 to Week 52)
Lost to Follow-up
|
19
|
10
|
|
Year 1 ( Week 0 to Week 52)
Protocol Violation
|
10
|
10
|
|
Year 1 ( Week 0 to Week 52)
Protocol Specified Discontinuation
|
19
|
25
|
|
Year 1 ( Week 0 to Week 52)
Patient Moved
|
6
|
2
|
|
Year 1 ( Week 0 to Week 52)
Withdrawal by Subject
|
25
|
28
|
|
Year 1 ( Week 0 to Week 52)
Site Terminated
|
2
|
2
|
|
Year 1 ( Week 0 to Week 52)
Other
|
10
|
11
|
|
Year 2 (Week 0 to Week 104)
Adverse Event
|
35
|
36
|
|
Year 2 (Week 0 to Week 104)
Lack of Efficacy
|
180
|
162
|
|
Year 2 (Week 0 to Week 104)
Lost to Follow-up
|
25
|
15
|
|
Year 2 (Week 0 to Week 104)
Protocol Violation
|
13
|
12
|
|
Year 2 (Week 0 to Week 104)
Protocol Specified Discontinuation
|
29
|
30
|
|
Year 2 (Week 0 to Week 104)
Patient Moved
|
6
|
2
|
|
Year 2 (Week 0 to Week 104)
Withdrawal by Subject
|
28
|
38
|
|
Year 2 (Week 0 to Week 104)
Site Terminated
|
2
|
2
|
|
Year 2 (Week 0 to Week 104)
Other
|
15
|
23
|
Baseline Characteristics
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg
n=588 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
Total
n=1172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 9.3 • n=93 Participants
|
56.6 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
56.7 years
STANDARD_DEVIATION 9.55 • n=27 Participants
|
|
Sex: Female, Male
Female
|
252 Participants
n=93 Participants
|
226 Participants
n=4 Participants
|
478 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
336 Participants
n=93 Participants
|
358 Participants
n=4 Participants
|
694 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
50 participants
n=93 Participants
|
49 participants
n=4 Participants
|
99 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
41 participants
n=93 Participants
|
35 participants
n=4 Participants
|
76 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
43 participants
n=93 Participants
|
46 participants
n=4 Participants
|
89 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
432 participants
n=93 Participants
|
434 participants
n=4 Participants
|
866 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
22 participants
n=93 Participants
|
20 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.7 Percent
STANDARD_DEVIATION 0.9 • n=93 Participants
|
7.6 Percent
STANDARD_DEVIATION 0.9 • n=4 Participants
|
7.7 Percent
STANDARD_DEVIATION 0.9 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: The per protocol population required that a participant had measurements both at baseline and at Week 52, and did not have any major protocol violations (e.g. drug compliance \< 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=382 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=411 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Change From Baseline in HbA1c at Week 52
|
-0.67 Percent
Interval -0.75 to -0.59
|
-0.67 Percent
Interval -0.75 to -0.59
|
SECONDARY outcome
Timeframe: Baseline and Week 104Population: The per protocol population required that a participant had measurements both at baseline and at Week 104, and did not have any major protocol violations (e.g. drug compliance \< 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=248 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=256 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Change From Baseline in HbA1c at Week 104
|
-0.54 Percent
Interval -0.64 to -0.45
|
-0.51 Percent
Interval -0.6 to -0.42
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.
Change from baseline at Week 52 is defined as Week 52 minus Week 0.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=389 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=416 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 52
|
-1.5 Kilograms
Interval -2.0 to -0.9
|
1.1 Kilograms
Interval 0.5 to 1.6
|
SECONDARY outcome
Timeframe: Baseline and Week 104Population: The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=253 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=261 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 104
|
-1.6 Kilograms
Interval -2.3 to -1.0
|
0.7 Kilograms
Interval 0.0 to 1.3
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: All randomized participants who received at least 1 dose of the double-blind study therapy.
Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=588 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Hypoglycemic Events at Week 52
Participants with one or more Hypoglycemic AEs
|
29 Participants
|
187 Participants
|
|
Hypoglycemic Events at Week 52
Total number of Hypoglycemic episodes
|
50 Participants
|
657 Participants
|
|
Hypoglycemic Events at Week 52
Participants with no Hypoglycemic AEs
|
559 Participants
|
397 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 104Population: All randomized participants who received at least 1 dose of the double-blind study therapy.
Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=588 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Hypoglycemic Events at Week 104
Participants with one or more Hypoglycemic AEs
|
31 Participants
|
199 Participants
|
|
Hypoglycemic Events at Week 104
Total number of Hypoglycemic episodes
|
57 Participants
|
805 Participants
|
|
Hypoglycemic Events at Week 104
Participants with no Hypoglycemic AEs
|
557 Participants
|
385 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 104Population: All randomized participants who received at least 1 dose of the double-blind study therapy.
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=588 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104
With CAES
|
452 Participants
|
480 Participants
|
|
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104
Without CAES
|
136 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 104Population: All randomized participants who received at least 1 dose of the double-blind study therapy.
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=588 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Number of Participants With Serious CAEs at Week 104
With serious CAEs
|
64 Participants
|
73 Participants
|
|
Number of Participants With Serious CAEs at Week 104
Without serious CAEs
|
524 Participants
|
511 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 104Population: All randomized participants who received at least 1 dose of the double-blind study therapy.
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=588 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Number of Participants With Drug-related CAEs at Week 104
With drug related CAEs
|
97 Participants
|
193 Participants
|
|
Number of Participants With Drug-related CAEs at Week 104
Without drug related CAEs
|
491 Participants
|
391 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 104Population: All randomized participants who received at least 1 dose of the double-blind study therapy.
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=588 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104
With LAEs
|
85 Participants
|
74 Participants
|
|
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104
Without LAEs
|
503 Participants
|
510 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 104Population: All randomized participants who received at least 1 dose of the double-blind study therapy.
Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=588 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Number of Participants With Serious LAEs at Week 104
With serious LAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious LAEs at Week 104
Without serious LAEs
|
588 Participants
|
584 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 104Population: All randomized participants who received at least 1 dose of the double-blind study therapy.
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=588 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 Participants
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Number of Participants With Drug-related LAEs at Week 104
|
18 Participants
|
21 Participants
|
Adverse Events
Sitagliptin 100 mg
Serious events: 64 serious events
Other events: 318 other events
Deaths: 0 deaths
Glipizide
Serious events: 73 serious events
Other events: 374 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 100 mg
n=588 participants at risk
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 participants at risk
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.17%
1/588
|
0.00%
0/584
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/588
|
0.34%
2/584
|
|
Cardiac disorders
Angina Pectoris
|
0.17%
1/588
|
0.51%
3/584
|
|
Cardiac disorders
Angina Unstable
|
0.17%
1/588
|
0.00%
0/584
|
|
Cardiac disorders
Atrial Fibrillation
|
0.51%
3/588
|
0.00%
0/584
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/588
|
0.17%
1/584
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.34%
2/588
|
0.17%
1/584
|
|
Cardiac disorders
Coronary Artery Disease
|
0.34%
2/588
|
0.00%
0/584
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.17%
1/588
|
0.00%
0/584
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.17%
1/588
|
0.00%
0/584
|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.17%
1/588
|
0.17%
1/584
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.17%
1/588
|
0.00%
0/584
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/588
|
0.34%
2/584
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/588
|
0.17%
1/584
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/588
|
0.17%
1/584
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.34%
2/588
|
0.17%
1/584
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
0.17%
1/588
|
0.00%
0/584
|
|
Eye disorders
Cataract
|
0.17%
1/588
|
0.00%
0/584
|
|
Eye disorders
Macular Hole
|
0.00%
0/588
|
0.17%
1/584
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/588
|
0.17%
1/584
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.17%
1/588
|
0.00%
0/584
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
0.00%
0/588
|
0.17%
1/584
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/588
|
0.17%
1/584
|
|
Gastrointestinal disorders
Diarrhoea
|
0.17%
1/588
|
0.00%
0/584
|
|
Gastrointestinal disorders
Dyspepsia
|
0.17%
1/588
|
0.00%
0/584
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/588
|
0.17%
1/584
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.17%
1/588
|
0.00%
0/584
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.17%
1/588
|
0.17%
1/584
|
|
Gastrointestinal disorders
Melaena
|
0.17%
1/588
|
0.00%
0/584
|
|
Gastrointestinal disorders
Pancreatitis
|
0.17%
1/588
|
0.00%
0/584
|
|
Gastrointestinal disorders
Rectal Polyp
|
0.17%
1/588
|
0.00%
0/584
|
|
Gastrointestinal disorders
Splenic Artery Aneurysm
|
0.00%
0/588
|
0.17%
1/584
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.17%
1/588
|
0.00%
0/584
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/588
|
0.17%
1/584
|
|
General disorders
Chest Pain
|
0.00%
0/588
|
0.17%
1/584
|
|
General disorders
Fatigue
|
0.17%
1/588
|
0.00%
0/584
|
|
General disorders
Non-Cardiac Chest Pain
|
0.34%
2/588
|
0.34%
2/584
|
|
General disorders
Oedema Peripheral
|
0.17%
1/588
|
0.00%
0/584
|
|
General disorders
Polyserositis
|
0.00%
0/588
|
0.17%
1/584
|
|
General disorders
Pyrexia
|
0.17%
1/588
|
0.00%
0/584
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/588
|
0.17%
1/584
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.17%
1/588
|
0.00%
0/584
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.17%
1/588
|
0.00%
0/584
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.17%
1/588
|
0.00%
0/584
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.68%
4/588
|
0.00%
0/584
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.17%
1/588
|
0.00%
0/584
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Arthritis Bacterial
|
0.17%
1/588
|
0.00%
0/584
|
|
Infections and infestations
Carbuncle
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Cellulitis
|
0.17%
1/588
|
0.34%
2/584
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Diabetic Foot Infection
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Gastroenteritis
|
0.17%
1/588
|
0.00%
0/584
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Helicobacter Infection
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Localised Infection
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Pneumonia
|
0.17%
1/588
|
0.51%
3/584
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Sepsis
|
0.00%
0/588
|
0.17%
1/584
|
|
Infections and infestations
Viral Infection
|
0.00%
0/588
|
0.17%
1/584
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/588
|
0.17%
1/584
|
|
Injury, poisoning and procedural complications
Burns Third Degree
|
0.00%
0/588
|
0.17%
1/584
|
|
Injury, poisoning and procedural complications
Fall
|
0.17%
1/588
|
0.00%
0/584
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.17%
1/588
|
0.17%
1/584
|
|
Injury, poisoning and procedural complications
Medical Device Complication
|
0.17%
1/588
|
0.00%
0/584
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.17%
1/588
|
0.34%
2/584
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.34%
2/588
|
0.00%
0/584
|
|
Injury, poisoning and procedural complications
Postoperative Thrombosis
|
0.00%
0/588
|
0.17%
1/584
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.17%
1/588
|
0.00%
0/584
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.17%
1/588
|
0.17%
1/584
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
0.17%
1/588
|
0.00%
0/584
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/588
|
0.17%
1/584
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.17%
1/588
|
0.00%
0/584
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/588
|
0.17%
1/584
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/588
|
0.17%
1/584
|
|
Metabolism and nutrition disorders
Diabetic Foot
|
0.00%
0/588
|
0.17%
1/584
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.17%
1/588
|
0.00%
0/584
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/588
|
0.17%
1/584
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/588
|
0.34%
2/584
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/588
|
0.17%
1/584
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.00%
0/588
|
0.17%
1/584
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/588
|
0.34%
2/584
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/588
|
0.34%
2/584
|
|
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage
|
0.17%
1/588
|
0.00%
0/584
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.17%
1/588
|
0.00%
0/584
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.34%
2/588
|
0.00%
0/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma Malignant
|
0.00%
0/588
|
0.17%
1/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.17%
1/588
|
0.51%
3/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.17%
1/588
|
0.00%
0/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.17%
1/588
|
0.00%
0/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/588
|
0.34%
2/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour Of The Small Bowel
|
0.00%
0/588
|
0.17%
1/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.17%
1/588
|
0.00%
0/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma
|
0.17%
1/588
|
0.00%
0/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.17%
1/588
|
0.00%
0/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant Non-Resectable
|
0.00%
0/588
|
0.17%
1/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/588
|
0.17%
1/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Bone
|
0.17%
1/588
|
0.00%
0/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Cancer Metastatic
|
0.00%
0/588
|
0.17%
1/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.17%
1/588
|
0.34%
2/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/588
|
0.17%
1/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Adenoma
|
0.17%
1/588
|
0.00%
0/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma Stage Unspecified
|
0.17%
1/588
|
0.17%
1/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Skin
|
0.17%
1/588
|
0.00%
0/584
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.17%
1/588
|
0.00%
0/584
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/588
|
0.17%
1/584
|
|
Nervous system disorders
Dizziness
|
0.00%
0/588
|
0.17%
1/584
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.00%
0/588
|
0.17%
1/584
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/588
|
0.17%
1/584
|
|
Nervous system disorders
Lethargy
|
0.00%
0/588
|
0.17%
1/584
|
|
Nervous system disorders
Loss Of Consciousness
|
0.00%
0/588
|
0.17%
1/584
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.34%
2/588
|
0.00%
0/584
|
|
Nervous system disorders
Syncope
|
0.00%
0/588
|
0.17%
1/584
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/588
|
0.17%
1/584
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/588
|
0.17%
1/584
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/588
|
0.17%
1/584
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/588
|
0.17%
1/584
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/588
|
0.17%
1/584
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.17%
1/588
|
0.00%
0/584
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/588
|
0.17%
1/584
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.17%
1/588
|
0.34%
2/584
|
|
Renal and urinary disorders
Renal Colic
|
0.17%
1/588
|
0.00%
0/584
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.17%
1/588
|
0.00%
0/584
|
|
Renal and urinary disorders
Renal Mass
|
0.00%
0/588
|
0.17%
1/584
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.17%
1/588
|
0.00%
0/584
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.17%
1/588
|
0.00%
0/584
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.17%
1/588
|
0.00%
0/584
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
1/588
|
0.00%
0/584
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/588
|
0.17%
1/584
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
1/588
|
0.00%
0/584
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian Syndrome
|
0.00%
0/588
|
0.17%
1/584
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/588
|
0.17%
1/584
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/588
|
0.17%
1/584
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/588
|
0.17%
1/584
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.17%
1/588
|
0.00%
0/584
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/588
|
0.17%
1/584
|
|
Vascular disorders
Extremity Necrosis
|
0.00%
0/588
|
0.17%
1/584
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.17%
1/588
|
0.00%
0/584
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.17%
1/588
|
0.00%
0/584
|
|
Vascular disorders
Venous Insufficiency
|
0.17%
1/588
|
0.00%
0/584
|
Other adverse events
| Measure |
Sitagliptin 100 mg
n=588 participants at risk
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Glipizide
n=584 participants at risk
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
42/588
|
6.8%
40/584
|
|
Infections and infestations
Bronchitis
|
6.8%
40/588
|
6.3%
37/584
|
|
Infections and infestations
Influenza
|
5.4%
32/588
|
6.3%
37/584
|
|
Infections and infestations
Nasopharyngitis
|
12.1%
71/588
|
10.4%
61/584
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
12.4%
73/588
|
13.5%
79/584
|
|
Infections and infestations
Urinary Tract Infection
|
7.5%
44/588
|
4.3%
25/584
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.3%
31/588
|
34.1%
199/584
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
34/588
|
5.5%
32/584
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.0%
35/588
|
5.5%
32/584
|
|
Nervous system disorders
Headache
|
5.6%
33/588
|
6.0%
35/584
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
23/588
|
5.5%
32/584
|
|
Vascular disorders
Hypertension
|
4.9%
29/588
|
5.3%
31/584
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER