Trial Outcomes & Findings for START-J: SiTAgliptin in eldeRly Trial in Japan (NCT NCT01183104)
NCT ID: NCT01183104
Last Updated: 2017-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
305 participants
Primary outcome timeframe
Baseline and 52 W
Results posted on
2017-04-14
Participant Flow
Participant milestones
| Measure |
Sitagliptin
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=\< \<50).
|
Glimepiride
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
152
|
|
Overall Study
Received Study Drug
|
148
|
143
|
|
Overall Study
Continued Treatment for 12 Weeks
|
143
|
129
|
|
Overall Study
Completed 52-week Treatment
|
119
|
111
|
|
Overall Study
Enrolled in Extension Study
|
80
|
61
|
|
Overall Study
COMPLETED
|
76
|
60
|
|
Overall Study
NOT COMPLETED
|
77
|
92
|
Reasons for withdrawal
| Measure |
Sitagliptin
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=\< \<50).
|
Glimepiride
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
6
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
14
|
7
|
|
Overall Study
Physician Decision
|
5
|
8
|
|
Overall Study
Withdrawal by Subject
|
6
|
11
|
|
Overall Study
Nonparticipation in Extension Study
|
39
|
50
|
|
Overall Study
Did not receive study drug
|
5
|
9
|
Baseline Characteristics
START-J: SiTAgliptin in eldeRly Trial in Japan
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=143 Participants
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50).
|
Glimepiride
n=129 Participants
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
70.8 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
143 participants
n=5 Participants
|
129 participants
n=7 Participants
|
272 participants
n=5 Participants
|
|
HbA1c
|
7.48 percent
STANDARD_DEVIATION 0.68 • n=5 Participants
|
7.49 percent
STANDARD_DEVIATION 0.67 • n=7 Participants
|
7.48 percent
STANDARD_DEVIATION 0.67 • n=5 Participants
|
|
BMI
|
24.1 kg/m^2
STANDARD_DEVIATION 3.3 • n=5 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 3.6 • n=7 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
eGFR
|
68.8 mL/min/1.73m^2
STANDARD_DEVIATION 17.1 • n=5 Participants
|
67.9 mL/min/1.73m^2
STANDARD_DEVIATION 17.1 • n=7 Participants
|
68.4 mL/min/1.73m^2
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Body weight
|
60.9 kg
STANDARD_DEVIATION 9.7 • n=5 Participants
|
60.9 kg
STANDARD_DEVIATION 9.7 • n=7 Participants
|
60.9 kg
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
HOMA-β
|
43.3 percent
STANDARD_DEVIATION 33.7 • n=5 Participants
|
38.5 percent
STANDARD_DEVIATION 34.0 • n=7 Participants
|
41.1 percent
STANDARD_DEVIATION 33.9 • n=5 Participants
|
|
Insulin/Proinsulin Ratio
|
0.217 ratio
STANDARD_DEVIATION 0.122 • n=5 Participants
|
0.205 ratio
STANDARD_DEVIATION 0.129 • n=7 Participants
|
0.211 ratio
STANDARD_DEVIATION 0.125 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 52 WPopulation: Analysis set of evaluation for efficacy; Per Protocol Set.
Outcome measures
| Measure |
Sitagliptin
n=143 Participants
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50).
|
Glimepiride
n=129 Participants
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
Change From Baseline in HbA1c at 52 W
|
-0.66 percent
Interval -0.77 to -0.54
|
-0.77 percent
Interval -0.88 to -0.66
|
PRIMARY outcome
Timeframe: From baseline to 52 WPopulation: Analysis set of evaluation for safety.
Outcome measures
| Measure |
Sitagliptin
n=148 Participants
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50).
|
Glimepiride
n=143 Participants
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
Number of Participants With Hypoglycaemia
|
7 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 52 WPopulation: Analysis set of evaluation for efficacy; Per Protocol Set Some participants were not completed to 52 W.
Outcome measures
| Measure |
Sitagliptin
n=134 Participants
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50).
|
Glimepiride
n=128 Participants
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
The Number of Participants Achieving HbA1c < 6.9 %
|
89 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Baseline and 52 WPopulation: Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.
β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = \[20 x fasting insulin (μU/mL)\] / \[fasting plasma glucose (mmol/L) - 3.5\]
Outcome measures
| Measure |
Sitagliptin
n=122 Participants
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50).
|
Glimepiride
n=119 Participants
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
Change From Baseline in HOMA-β at 52 W
|
10.2 percent
Standard Deviation 35.7
|
23.7 percent
Standard Deviation 56.1
|
SECONDARY outcome
Timeframe: Baseline and 52 WPopulation: Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.
Outcome measures
| Measure |
Sitagliptin
n=120 Participants
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50).
|
Glimepiride
n=112 Participants
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
Change From Baseline in Insulin/Proinsulin Ratio at 52 W
|
-0.049 ratio
Standard Deviation 0.111
|
-0.002 ratio
Standard Deviation 0.095
|
SECONDARY outcome
Timeframe: Baseline and 52 WPopulation: Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.
Outcome measures
| Measure |
Sitagliptin
n=134 Participants
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50).
|
Glimepiride
n=127 Participants
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
Change From Baseline in Body Weight at 52 W
|
-0.367 kg
Standard Deviation 2.441
|
0.309 kg
Standard Deviation 2.915
|
Adverse Events
Sitagliptin
Serious events: 13 serious events
Other events: 33 other events
Deaths: 0 deaths
Glimepiride
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin
n=148 participants at risk
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50).
|
Glimepiride
n=143 participants at risk
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.68%
1/148
|
0.00%
0/143
|
|
Infections and infestations
Infectious enteritis
|
0.68%
1/148
|
0.00%
0/143
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukemia
|
0.68%
1/148
|
0.00%
0/143
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.68%
1/148
|
0.00%
0/143
|
|
Blood and lymphatic system disorders
Hemorrhagic diathesis
|
0.68%
1/148
|
0.00%
0/143
|
|
Nervous system disorders
Cerebral infarction
|
0.68%
1/148
|
0.00%
0/143
|
|
Eye disorders
Hyphema
|
0.68%
1/148
|
0.00%
0/143
|
|
Cardiac disorders
Acute myocardial infarction
|
0.68%
1/148
|
0.00%
0/143
|
|
Cardiac disorders
Complete atrioventricular block
|
0.00%
0/148
|
0.70%
1/143
|
|
Cardiac disorders
Takotsubo cardiomyopathy
|
0.68%
1/148
|
0.00%
0/143
|
|
Gastrointestinal disorders
Colon polyp
|
0.00%
0/148
|
0.70%
1/143
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.68%
1/148
|
0.00%
0/143
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.68%
1/148
|
0.00%
0/143
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.68%
1/148
|
0.00%
0/143
|
|
Renal and urinary disorders
Renal failure
|
0.68%
1/148
|
0.00%
0/143
|
|
General disorders
Death
|
0.00%
0/148
|
0.70%
1/143
|
|
Injury, poisoning and procedural complications
Globe rupture
|
0.68%
1/148
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.68%
1/148
|
0.00%
0/143
|
Other adverse events
| Measure |
Sitagliptin
n=148 participants at risk
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\< \<50).
|
Glimepiride
n=143 participants at risk
Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
|
|---|---|---|
|
Infections and infestations
Intestinal abscess
|
0.68%
1/148
|
0.00%
0/143
|
|
Infections and infestations
Appendicitis
|
0.68%
1/148
|
0.00%
0/143
|
|
Infections and infestations
Bronchitis
|
1.4%
2/148
|
0.00%
0/143
|
|
Infections and infestations
Cystitis
|
2.0%
3/148
|
0.00%
0/143
|
|
Infections and infestations
Herpes zoster
|
0.68%
1/148
|
0.00%
0/143
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
8/148
|
4.9%
7/143
|
|
Infections and infestations
Pharyngitis
|
0.68%
1/148
|
0.00%
0/143
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/148
|
0.70%
1/143
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile ｄuct ｃancer
|
0.68%
1/148
|
0.00%
0/143
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon ｃancer
|
1.4%
2/148
|
0.00%
0/143
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythemia vera
|
1.4%
2/148
|
0.00%
0/143
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.68%
1/148
|
0.00%
0/143
|
|
Blood and lymphatic system disorders
Anemia
|
0.68%
1/148
|
0.00%
0/143
|
|
Blood and lymphatic system disorders
Mediastinal lymphadenopathy
|
0.68%
1/148
|
0.00%
0/143
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/148
|
0.70%
1/143
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.68%
1/148
|
0.00%
0/143
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/148
|
1.4%
2/143
|
|
Metabolism and nutrition disorders
Loss of appetite
|
0.68%
1/148
|
0.00%
0/143
|
|
Psychiatric disorders
Depression
|
0.68%
1/148
|
0.00%
0/143
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/148
|
0.70%
1/143
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/148
|
0.70%
1/143
|
|
Nervous system disorders
Dizziness
|
0.00%
0/148
|
0.70%
1/143
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/148
|
1.4%
2/143
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/148
|
0.70%
1/143
|
|
Nervous system disorders
Sciatica
|
0.68%
1/148
|
0.00%
0/143
|
|
Eye disorders
Allergic conjunctivitis
|
0.00%
0/148
|
0.70%
1/143
|
|
Eye disorders
Pterygium
|
0.00%
0/148
|
0.70%
1/143
|
|
Eye disorders
Retinal hemorrhages
|
0.68%
1/148
|
0.00%
0/143
|
|
Eye disorders
Vision blurred
|
0.00%
0/148
|
0.70%
1/143
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/148
|
0.70%
1/143
|
|
Cardiac disorders
Atrial fibrillation
|
0.68%
1/148
|
0.00%
0/143
|
|
Cardiac disorders
Heart failure
|
0.00%
0/148
|
0.70%
1/143
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/148
|
0.70%
1/143
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.68%
1/148
|
0.00%
0/143
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/148
|
0.70%
1/143
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.0%
3/148
|
0.70%
1/143
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/148
|
1.4%
2/143
|
|
Gastrointestinal disorders
Constipation
|
0.68%
1/148
|
0.70%
1/143
|
|
Gastrointestinal disorders
Diarrhea
|
0.68%
1/148
|
0.00%
0/143
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.68%
1/148
|
0.00%
0/143
|
|
Gastrointestinal disorders
Erosive gastritis
|
0.00%
0/148
|
0.70%
1/143
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.68%
1/148
|
0.00%
0/143
|
|
Gastrointestinal disorders
Hemorrhoid
|
0.68%
1/148
|
0.00%
0/143
|
|
Gastrointestinal disorders
Stomatitis
|
0.68%
1/148
|
0.00%
0/143
|
|
Hepatobiliary disorders
Choledocholith
|
0.68%
1/148
|
0.00%
0/143
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.68%
1/148
|
0.00%
0/143
|
|
Hepatobiliary disorders
Liver Cyst
|
0.00%
0/148
|
0.70%
1/143
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/148
|
0.70%
1/143
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/148
|
0.70%
1/143
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.68%
1/148
|
0.70%
1/143
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis
|
0.00%
0/148
|
0.70%
1/143
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/148
|
0.70%
1/143
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
1/148
|
0.00%
0/143
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.68%
1/148
|
0.00%
0/143
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/148
|
0.70%
1/143
|
|
Musculoskeletal and connective tissue disorders
Spondylosis deformans
|
0.68%
1/148
|
0.00%
0/143
|
|
Musculoskeletal and connective tissue disorders
Hygroma
|
0.00%
0/148
|
0.70%
1/143
|
|
Musculoskeletal and connective tissue disorders
Tenovaginitis
|
0.00%
0/148
|
0.70%
1/143
|
|
Musculoskeletal and connective tissue disorders
Disc protrusion
|
0.68%
1/148
|
0.00%
0/143
|
|
Renal and urinary disorders
Ureteral calculus
|
0.00%
0/148
|
0.70%
1/143
|
|
General disorders
Face edema
|
0.00%
0/148
|
0.70%
1/143
|
|
General disorders
Malaise
|
0.68%
1/148
|
0.70%
1/143
|
|
General disorders
Fever
|
0.00%
0/148
|
0.70%
1/143
|
|
Investigations
Blood pressure increased
|
0.00%
0/148
|
0.70%
1/143
|
|
Investigations
Blood uric acid increased
|
0.68%
1/148
|
0.00%
0/143
|
|
Investigations
Platelet count decreased
|
0.68%
1/148
|
0.00%
0/143
|
|
Investigations
T-wave abnormality
|
0.00%
0/148
|
0.70%
1/143
|
|
Injury, poisoning and procedural complications
Injury
|
1.4%
2/148
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
Sprained ligament
|
0.68%
1/148
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
Wrist join fraction
|
0.68%
1/148
|
0.00%
0/143
|
|
Surgical and medical procedures
Ureteral stone removal
|
0.00%
0/148
|
0.70%
1/143
|
|
Surgical and medical procedures
Dental care
|
0.68%
1/148
|
0.00%
0/143
|
|
Surgical and medical procedures
Cataract operation
|
0.68%
1/148
|
0.00%
0/143
|
Additional Information
Prof. Yasuo Terauchi
Japan Association for Diabetes Education and Care
Phone: +81-3-3514-1721
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place