Trial Outcomes & Findings for Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1) (NCT NCT00509236)
NCT ID: NCT00509236
Last Updated: 2017-05-12
Results Overview
Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
Baseline / Week 54
Results posted on
2017-05-12
Participant Flow
Participant milestones
| Measure |
Sitagliptin 25 mg
One 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
Between 2.5 mg - 20 mg daily for 54 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
65
|
|
Overall Study
COMPLETED
|
47
|
45
|
|
Overall Study
NOT COMPLETED
|
17
|
20
|
Reasons for withdrawal
| Measure |
Sitagliptin 25 mg
One 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
Between 2.5 mg - 20 mg daily for 54 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
9
|
|
Overall Study
Withdrawal by Subject
|
5
|
10
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Excluded Medication
|
1
|
1
|
|
Overall Study
Scheduled Kidney Transplant
|
1
|
0
|
Baseline Characteristics
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
Baseline characteristics by cohort
| Measure |
Sitagliptin 25 mg
n=64 Participants
One 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
n=65 Participants
Between 2.5 mg - 20 mg daily for 54 weeks
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline / Week 54Population: Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.
Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.
Outcome measures
| Measure |
Sitagliptin 25 mg
n=62 Participants
Participants received one 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
Participants received between 2.5 mg - 20 mg daily for 54 weeks
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment
Baseline
|
7.89 Percent hemoglobin A1c
Standard Deviation 0.74
|
—
|
|
Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment
Week 54
|
7.15 Percent hemoglobin A1c
Standard Deviation 0.98
|
—
|
|
Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment
Change from Baseline at Week 54
|
-0.74 Percent hemoglobin A1c
Standard Deviation 0.95
|
—
|
PRIMARY outcome
Timeframe: 54 Week Treatment Period + 28 daysPopulation: All randomized participants.
Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.
Outcome measures
| Measure |
Sitagliptin 25 mg
n=64 Participants
Participants received one 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
n=65 Participants
Participants received between 2.5 mg - 20 mg daily for 54 weeks
|
|---|---|---|
|
Number of Participants With Clinical Adverse Events
|
53 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 54 Week Treatment Period + 28 daysPopulation: All randomized participants.
A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.
Outcome measures
| Measure |
Sitagliptin 25 mg
n=64 Participants
Participants received one 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
n=65 Participants
Participants received between 2.5 mg - 20 mg daily for 54 weeks
|
|---|---|---|
|
Number of Participants With Symptomatic Hypoglycemic Adverse Events
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline / Week 54Population: Randomized participants. Numbers analyzed excluded participants with no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.
Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.
Outcome measures
| Measure |
Sitagliptin 25 mg
n=60 Participants
Participants received one 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
n=59 Participants
Participants received between 2.5 mg - 20 mg daily for 54 weeks
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from Baseline to Week 54
|
-24.5 mg/dL
Standard Deviation 47.5
|
-33.0 mg/dL
Standard Deviation 55.9
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Baseline
|
160.3 mg/dL
Standard Deviation 48.5
|
167.0 mg/dL
Standard Deviation 56.2
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 54
|
135.8 mg/dL
Standard Deviation 40.4
|
134.0 mg/dL
Standard Deviation 58.2
|
SECONDARY outcome
Timeframe: Baseline / Week 54Population: Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.
Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated.
Outcome measures
| Measure |
Sitagliptin 25 mg
n=62 Participants
Participants received one 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
n=59 Participants
Participants received between 2.5 mg - 20 mg daily for 54 weeks
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment
|
-0.72 Percent hemoglobin A1c
Interval -0.95 to -0.48
|
-0.87 Percent hemoglobin A1c
Interval -1.11 to -0.63
|
Adverse Events
Sitagliptin 25 mg
Serious events: 23 serious events
Other events: 33 other events
Deaths: 0 deaths
Glipizide 2.5 mg - 20 mg
Serious events: 22 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 25 mg
n=64 participants at risk
One 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
n=65 participants at risk
Between 2.5 mg - 20 mg daily for 54 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
1/64 • Number of events 1
|
3.1%
2/65 • Number of events 3
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Left ventricular dysfunstion
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/64 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Abdominal adhesions
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Enteritis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/64 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/64
|
3.1%
2/65 • Number of events 2
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
General disorders
Device malfunction
|
3.1%
2/64 • Number of events 2
|
0.00%
0/65
|
|
General disorders
Device occlusion
|
1.6%
1/64 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
General disorders
Medical device complication
|
1.6%
1/64 • Number of events 2
|
0.00%
0/65
|
|
General disorders
Pyrexia
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/64
|
6.2%
4/65 • Number of events 4
|
|
Infections and infestations
Cellulitis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Device related infection
|
1.6%
1/64 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/64
|
1.5%
1/65 • Number of events 3
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
3.1%
2/64 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Necrotising fasciitis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Pneumonia
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Pulmonary tuberculosis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Septic shock
|
3.1%
2/64 • Number of events 2
|
0.00%
0/65
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/64
|
3.1%
2/65 • Number of events 2
|
|
Infections and infestations
Tonsillitis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Urinary tract infection
|
3.1%
2/64 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.6%
1/64 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
3.1%
2/64 • Number of events 2
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Investigations
Liver function test abnormal
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic foot
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.6%
1/64 • Number of events 2
|
3.1%
2/65 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
3.1%
2/64 • Number of events 2
|
0.00%
0/65
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Vascular disorders
Aortic dissection
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Vascular disorders
Hypotension
|
1.6%
1/64 • Number of events 2
|
1.5%
1/65 • Number of events 2
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
Other adverse events
| Measure |
Sitagliptin 25 mg
n=64 participants at risk
One 25 mg tablet once daily for 54 weeks
|
Glipizide 2.5 mg - 20 mg
n=65 participants at risk
Between 2.5 mg - 20 mg daily for 54 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
2/64 • Number of events 2
|
7.7%
5/65 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
4/64 • Number of events 6
|
3.1%
2/65 • Number of events 2
|
|
General disorders
Oedema peripheral
|
1.6%
1/64 • Number of events 1
|
7.7%
5/65 • Number of events 5
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
3/64 • Number of events 3
|
10.8%
7/65 • Number of events 8
|
|
Infections and infestations
Urinary tract infection
|
7.8%
5/64 • Number of events 6
|
1.5%
1/65 • Number of events 1
|
|
Investigations
Blood glucose decreased
|
17.2%
11/64 • Number of events 37
|
27.7%
18/65 • Number of events 94
|
|
Investigations
Blood glucose increased
|
6.2%
4/64 • Number of events 11
|
7.7%
5/65 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
4/64 • Number of events 7
|
10.8%
7/65 • Number of events 16
|
|
Nervous system disorders
Headache
|
6.2%
4/64 • Number of events 4
|
0.00%
0/65
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.9%
7/64 • Number of events 7
|
9.2%
6/65 • Number of events 7
|
|
Vascular disorders
Hypertension
|
7.8%
5/64 • Number of events 7
|
9.2%
6/65 • Number of events 6
|
|
Vascular disorders
Hypotension
|
6.2%
4/64 • Number of events 7
|
1.5%
1/65 • Number of events 1
|
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 Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or colleagues may publish the results for their study site independently. 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