Trial Outcomes & Findings for Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients (NCT NCT00751114)
NCT ID: NCT00751114
Last Updated: 2012-09-10
Results Overview
Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
515 participants
Primary outcome timeframe
baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Results posted on
2012-09-10
Participant Flow
EASIE was a multicenter, international, randomized, open-label trial conducted from November 12, 2008 to July 28, 2011.
A total of 732 patients were screened in 96 centers in 17 countries. The study included an initial 2-week screening period. A total of 217 patients were screen failures. The main reason for screen failure was Glycosylated Hemoglobin A1c (HbA1c) inclusion criterion not met (146 patients).
Participant milestones
| Measure |
Insulin Glargine
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the Fasting Plasma Glucose (FPG) target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
265
|
|
Overall Study
TREATED = Safety Population
|
237
|
264
|
|
Overall Study
mITT Population
|
227
|
253
|
|
Overall Study
COMPLETED
|
212
|
233
|
|
Overall Study
NOT COMPLETED
|
38
|
32
|
Reasons for withdrawal
| Measure |
Insulin Glargine
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the Fasting Plasma Glucose (FPG) target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Protocol Violation
|
8
|
9
|
|
Overall Study
Withdrawal by Subject
|
9
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
|
Overall Study
Lack of Efficacy
|
0
|
7
|
|
Overall Study
Not Treated
|
13
|
1
|
|
Overall Study
Out of country for 2 months
|
1
|
0
|
|
Overall Study
Move to another city
|
1
|
0
|
Baseline Characteristics
Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
Baseline characteristics by cohort
| Measure |
Insulin Glargine
n=227 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=253 Participants
Dose of 100 mg once a day administered with or without food
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53.9 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
114 participants
n=5 Participants
|
132 participants
n=7 Participants
|
246 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
113 participants
n=5 Participants
|
121 participants
n=7 Participants
|
234 participants
n=5 Participants
|
|
Body Weight
|
83.4 kg
STANDARD_DEVIATION 18.2 • n=5 Participants
|
84.2 kg
STANDARD_DEVIATION 18.3 • n=7 Participants
|
83.8 kg
STANDARD_DEVIATION 18.2 • n=5 Participants
|
|
Body Mass Index
|
31.05 kg/m²
STANDARD_DEVIATION 4.93 • n=5 Participants
|
31.13 kg/m²
STANDARD_DEVIATION 4.95 • n=7 Participants
|
31.09 kg/m²
STANDARD_DEVIATION 4.93 • n=5 Participants
|
|
Systolic Blood Pressure
|
129.8 mmHg
STANDARD_DEVIATION 13.3 • n=5 Participants
|
131.7 mmHg
STANDARD_DEVIATION 15.1 • n=7 Participants
|
130.8 mmHg
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Diastolic Blood Pressure
|
79.5 mmHg
STANDARD_DEVIATION 8.7 • n=5 Participants
|
80.0 mmHg
STANDARD_DEVIATION 8.3 • n=7 Participants
|
79.7 mmHg
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Heart Rate
|
75.6 beats/min
STANDARD_DEVIATION 8.7 • n=5 Participants
|
76.3 beats/min
STANDARD_DEVIATION 9.3 • n=7 Participants
|
76.0 beats/min
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Duration of diabetes
|
3.9 years
n=5 Participants
|
4.8 years
n=7 Participants
|
4.5 years
n=5 Participants
|
|
At least one diabetic late complication
Yes
|
65 participants
n=5 Participants
|
67 participants
n=7 Participants
|
132 participants
n=5 Participants
|
|
At least one diabetic late complication
No
|
162 participants
n=5 Participants
|
186 participants
n=7 Participants
|
348 participants
n=5 Participants
|
|
Glycosylated Hemoglobin A1c (HbA1c)
|
8.5 percent
STANDARD_DEVIATION 1.0 • n=5 Participants
|
8.5 percent
STANDARD_DEVIATION 1.1 • n=7 Participants
|
8.5 percent
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Fasting Plasma Glucose
|
163.6 mg/dL
STANDARD_DEVIATION 42.0 • n=5 Participants
|
171.1 mg/dL
STANDARD_DEVIATION 41.5 • n=7 Participants
|
167.5 mg/dL
STANDARD_DEVIATION 41.9 • n=5 Participants
|
|
Self-monitored Fasting Plasma Glucose
|
163.9 mg/dL
STANDARD_DEVIATION 37.6 • n=5 Participants
|
166.7 mg/dL
STANDARD_DEVIATION 38.2 • n=7 Participants
|
165.4 mg/dL
STANDARD_DEVIATION 37.9 • n=5 Participants
|
|
Total Cholesterol
|
185.9 mg/dL
STANDARD_DEVIATION 41.4 • n=5 Participants
|
187.1 mg/dL
STANDARD_DEVIATION 39.0 • n=7 Participants
|
186.5 mg/dL
STANDARD_DEVIATION 40.1 • n=5 Participants
|
|
High-Density Lipoprotein (HDL) Cholesterol
|
46.2 mg/dL
STANDARD_DEVIATION 14.6 • n=5 Participants
|
45.0 mg/dL
STANDARD_DEVIATION 11.2 • n=7 Participants
|
45.6 mg/dL
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Low-Density Lipoprotein (LDL) Cholesterol
|
112.7 mg/dL
STANDARD_DEVIATION 36.2 • n=5 Participants
|
114.2 mg/dL
STANDARD_DEVIATION 33.2 • n=7 Participants
|
113.5 mg/dL
STANDARD_DEVIATION 34.6 • n=5 Participants
|
|
Triglycerides
|
190.9 mg/dL
STANDARD_DEVIATION 142.0 • n=5 Participants
|
185.7 mg/dL
STANDARD_DEVIATION 114.6 • n=7 Participants
|
188.2 mg/dL
STANDARD_DEVIATION 128.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements. The Last Observation Carried Forward method was used for imputing missing data for the end of treatment value.
Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.
Outcome measures
| Measure |
Insulin Glargine
n=224 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=248 Participants
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
HbA1c: Change From Baseline to Study Endpoint
|
-1.72 percent
Standard Error 0.06
|
-1.13 percent
Standard Error 0.06
|
SECONDARY outcome
Timeframe: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.
Outcome measures
| Measure |
Insulin Glargine
n=224 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=248 Participants
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint
|
67.9 percentage of participants
|
41.9 percentage of participants
|
SECONDARY outcome
Timeframe: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.
Outcome measures
| Measure |
Insulin Glargine
n=224 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=248 Participants
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint
|
40.2 percentage of participants
|
16.9 percentage of participants
|
SECONDARY outcome
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available valuePopulation: The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements. Adjusted means were estimated from ANCOVA model using baseline value as covariate.
SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed). Study endpoint was defined as the last available SMFPG mean value collected on-treatment. Change= study endpoint - baseline
Outcome measures
| Measure |
Insulin Glargine
n=214 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=244 Participants
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
|
-60.52 mg/dL
Standard Error 1.85
|
-19.35 mg/dL
Standard Error 1.73
|
SECONDARY outcome
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint. Depending on the time point, few values were missing. Adjusted means were estimated from ANCOVA model using baseline value as covariate.
7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime. Change = study endpoint - baseline.
Outcome measures
| Measure |
Insulin Glargine
n=203 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=227 Participants
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
Before breakfast (N ig = 203 & N s = 226)
|
-59.90 mg/dL
Standard Error 2.02
|
-20.39 mg/dL
Standard Error 1.91
|
|
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
After breakfast (N ig = 202 & N s = 220)
|
-66.25 mg/dL
Standard Error 3.03
|
-36.41 mg/dL
Standard Error 2.90
|
|
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
Before lunch (N ig = 201 & N s = 223)
|
-48.00 mg/dL
Standard Error 2.33
|
-19.82 mg/dL
Standard Error 2.21
|
|
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
After lunch (N ig = 202 & N s = 226)
|
-45.54 mg/dL
Standard Error 2.82
|
-26.10 mg/dL
Standard Error 2.66
|
|
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
Before dinner (N ig = 199 & N s = 223)
|
-40.68 mg/dL
Standard Error 2.61
|
-25.07 mg/dL
Standard Error 2.47
|
|
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
After dinner (N ig = 196 & N s = 220)
|
-45.88 mg/dL
Standard Error 2.69
|
-33.78 mg/dL
Standard Error 2.54
|
|
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
At bedtime (N ig = 177 & N s = 210)
|
-45.58 mg/dL
Standard Error 3.15
|
-31.16 mg/dL
Standard Error 2.89
|
SECONDARY outcome
Timeframe: visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available valuePopulation: The population analyzed for this outcome was the safety population defined as randomized patients who received at least one dose of investigational product.
Daily dose at the face-to-face visits.
Outcome measures
| Measure |
Insulin Glargine
n=237 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Insulin Dose in the Insulin Glargine Group
First dose received N=236
|
0.19 unit per kg body weight
Standard Deviation 0.03
|
—
|
|
Insulin Dose in the Insulin Glargine Group
Visit 4 (week 2) N=230
|
0.27 unit per kg body weight
Standard Deviation 0.08
|
—
|
|
Insulin Dose in the Insulin Glargine Group
Visit 8 (week 6) N=222
|
0.38 unit per kg body weight
Standard Deviation 0.16
|
—
|
|
Insulin Dose in the Insulin Glargine Group
Visit 11 (week 12) N=219
|
0.45 unit per kg body weight
Standard Deviation 0.20
|
—
|
|
Insulin Dose in the Insulin Glargine Group
Visit 12 (week 16) N=214
|
0.48 unit per kg body weight
Standard Deviation 0.23
|
—
|
|
Insulin Dose in the Insulin Glargine Group
Visit 14 (week 24) N=220
|
0.50 unit per kg body weight
Standard Deviation 0.26
|
—
|
|
Insulin Dose in the Insulin Glargine Group
Study endpoint N=237
|
0.49 unit per kg body weight
Standard Deviation 0.26
|
—
|
SECONDARY outcome
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements. Adjusted means were estimated from ANCOVA model using baseline value as covariate.
Outcome measures
| Measure |
Insulin Glargine
n=222 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=243 Participants
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Lipid Profile: Change From Baseline to Study Endpoint
Change in Total Cholesterol
|
-7.94 mg/dL
Standard Error 2.06
|
-1.54 mg/dL
Standard Error 1.97
|
|
Lipid Profile: Change From Baseline to Study Endpoint
Change in LDL Cholesterol
|
-3.68 mg/dL
Standard Error 1.71
|
-0.19 mg/dL
Standard Error 1.63
|
|
Lipid Profile: Change From Baseline to Study Endpoint
Change in HDL Cholesterol
|
0.13 mg/dL
Standard Error 0.54
|
0.57 mg/dL
Standard Error 0.52
|
|
Lipid Profile: Change From Baseline to Study Endpoint
Change in Triglycerides
|
-34.07 mg/dL
Standard Error 8.14
|
0.31 mg/dL
Standard Error 7.78
|
SECONDARY outcome
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available valuePopulation: The population analyzed for this outcome measure consisted of the subset of the safety population (treated patients) who had both baseline and endpoint measurements. Adjusted means were estimated from ANCOVA model using baseline value as covariate.
Outcome measures
| Measure |
Insulin Glargine
n=227 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=255 Participants
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Change in Body Weight From Baseline to Study Endpoint
|
0.44 kg
Standard Error 0.22
|
-1.08 kg
Standard Error 0.20
|
SECONDARY outcome
Timeframe: During the treatment phase (24 weeks) plus 7 days after last dosePopulation: The population analyzed for this outcome measure was the safety population (treated patients)
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement \<= 70mg/dL \[3.9 mmol/L\]
Outcome measures
| Measure |
Insulin Glargine
n=237 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=264 Participants
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Number of Patients With at Least One Episode of Symptomatic Hypoglycemia
|
108 participants
|
35 participants
|
SECONDARY outcome
Timeframe: During the treatment phase (24 weeks) plus 7 days after last dosePopulation: The population analyzed for this outcome measure was the safety population (treated patients)
Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level \< 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
Outcome measures
| Measure |
Insulin Glargine
n=237 Participants
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=264 Participants
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia
|
3 participants
|
1 participants
|
Adverse Events
Insulin Glargine
Serious events: 15 serious events
Other events: 27 other events
Deaths: 0 deaths
Sitagliptin
Serious events: 8 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Glargine
n=237 participants at risk
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=264 participants at risk
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.38%
1/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Cardiac disorders
Angina pectoris
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.38%
1/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Cardiac disorders
Angina unstable
|
0.84%
2/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.38%
1/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
General disorders
Non-cardiac chest pain
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Infections and infestations
Anal abscess
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.38%
1/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.84%
2/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.38%
1/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.38%
1/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.38%
1/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Nervous system disorders
Carotid artery occlusion
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Nervous system disorders
Epilepsy
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Nervous system disorders
Loss of consciousness
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Nervous system disorders
Nerve compression
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Renal and urinary disorders
Calculus ureteric
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Renal and urinary disorders
Renal colic
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Vascular disorders
Hypertension
|
0.00%
0/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.38%
1/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Vascular disorders
Orthostatic hypotension
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.42%
1/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
0.00%
0/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
Other adverse events
| Measure |
Insulin Glargine
n=237 participants at risk
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L)
|
Sitagliptin
n=264 participants at risk
Dose of 100 mg once a day administered with or without food
|
|---|---|---|
|
Infections and infestations
Influenza
|
3.4%
8/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
5.7%
15/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
8/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
5.7%
15/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
|
Nervous system disorders
Headache
|
6.3%
15/237 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
5.3%
14/264 • Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 45 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER