Trial Outcomes & Findings for Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) (NCT NCT00494013)
NCT ID: NCT00494013
Last Updated: 2009-11-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
442 participants
Primary outcome timeframe
Baseline, 24 Weeks
Results posted on
2009-11-11
Participant Flow
789 patients were screened; 347 patients failed screening or discontinued before randomization. Demographics and outcomes are reported on the "Full Analysis Set": all randomized patients who received at least one dose of study drug and had at least one post-baseline measurement for the dependent variable, according to Intent to Treat principles.
Participant milestones
| Measure |
Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
219
|
|
Overall Study
Full Analysis Set (Intent to Treat)
|
219
|
210
|
|
Overall Study
COMPLETED
|
193
|
183
|
|
Overall Study
NOT COMPLETED
|
30
|
36
|
Reasons for withdrawal
| Measure |
Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Entry Criteria Not Met
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Physician Decision
|
3
|
5
|
|
Overall Study
Protocol Violation
|
8
|
5
|
|
Overall Study
Withdrawal by Subject
|
13
|
14
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
Baseline Characteristics
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
Baseline characteristics by cohort
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
Total
n=429 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.32 years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
55.73 years
STANDARD_DEVIATION 10.20 • n=7 Participants
|
56.03 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
India
|
42 participants
n=5 Participants
|
39 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
56 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
88 participants
n=5 Participants
|
82 participants
n=7 Participants
|
170 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
45 participants
n=5 Participants
|
47 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Race/Ethnicity
West Asian
|
43 participants
n=5 Participants
|
40 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Sulfonylurea Group
Yes
|
170 participants
n=5 Participants
|
158 participants
n=7 Participants
|
328 participants
n=5 Participants
|
|
Sulfonylurea Group
No
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Sulfonylurea Group
Unavailable
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.03 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.01 • n=5 Participants
|
30.10 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.12 • n=7 Participants
|
30.06 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.06 • n=5 Participants
|
|
Body Weight
|
81.10 kilograms (kg)
STANDARD_DEVIATION 17.46 • n=5 Participants
|
82.72 kilograms (kg)
STANDARD_DEVIATION 19.32 • n=7 Participants
|
81.89 kilograms (kg)
STANDARD_DEVIATION 18.39 • n=5 Participants
|
|
Duration of Diabetes
|
9.48 years
STANDARD_DEVIATION 6.09 • n=5 Participants
|
8.94 years
STANDARD_DEVIATION 5.59 • n=7 Participants
|
9.22 years
STANDARD_DEVIATION 5.85 • n=5 Participants
|
|
Height
|
163.94 centimeters (cm)
STANDARD_DEVIATION 10.19 • n=5 Participants
|
165.14 centimeters (cm)
STANDARD_DEVIATION 10.94 • n=7 Participants
|
164.53 centimeters (cm)
STANDARD_DEVIATION 10.57 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Baseline (n=209, n=202)
|
8.79 percent of HbA1c
Standard Error 0.06
|
8.77 percent of HbA1c
Standard Error 0.06
|
|
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Change from Baseline (n=209, n=202)
|
-1.52 percent of HbA1c
Standard Error 0.08
|
-1.31 percent of HbA1c
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, 12 Weeks, 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Baseline
|
8.79 percent hemoglobin
Standard Error 0.06
|
8.77 percent hemoglobin
Standard Error 0.06
|
|
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Week 12 HbA1c
|
7.44 percent hemoglobin
Standard Error 0.08
|
7.55 percent hemoglobin
Standard Error 0.07
|
|
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Week 12 Change from Baseline
|
-1.33 percent hemoglobin
Standard Error 0.08
|
-1.22 percent hemoglobin
Standard Error 0.07
|
|
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Week 24 HbA1c
|
7.14 percent hemoglobin
Standard Error 0.09
|
7.34 percent hemoglobin
Standard Error 0.08
|
|
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Week 24 Change from Baseline
|
-1.63 percent hemoglobin
Standard Error 0.09
|
-1.43 percent hemoglobin
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.
Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
HbA1c <7.0%
|
34.9 percentage of participants
|
31.2 percentage of participants
|
|
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
HbA1c ≤6.5%
|
22.5 percentage of participants
|
16.3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.
Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose \[SMBG\] profiles at endpoint) for the actual morning pre-meal blood glucose value.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=218 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=208 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Glycemic Variability
|
1.14 millimoles per Liter (mmol/L)
Standard Deviation 0.64
|
1.04 millimoles per Liter (mmol/L)
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.
Actual daily mean blood glucose levels at endpoint.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
Average 7-Point SMBG
|
8.25 millimoles per liter (mmol/L)
Standard Deviation 1.58
|
8.26 millimoles per liter (mmol/L)
Standard Deviation 1.73
|
|
7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
Average Pre-Meal
|
7.48 millimoles per liter (mmol/L)
Standard Deviation 1.69
|
7.43 millimoles per liter (mmol/L)
Standard Deviation 1.69
|
|
7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
Average Post-Meal
|
9.37 millimoles per liter (mmol/L)
Standard Deviation 1.91
|
9.42 millimoles per liter (mmol/L)
Standard Deviation 2.21
|
|
7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
Average Morning+Evening Pre-Meal
|
7.49 millimoles per liter (mmol/L)
Standard Deviation 1.68
|
7.40 millimoles per liter (mmol/L)
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.
Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level \<7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value \<2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Results are for the combined titration and maintenance periods.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods
All Hypoglycemic Episodes
|
151 participants
|
137 participants
|
|
Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods
Nocturnal Hypoglycemic Episodes
|
99 participants
|
68 participants
|
|
Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods
Severe Hypoglycemic Episodes (N=214, N=207)
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.
Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level \<7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value \<2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Hypoglycemic Rate
|
24.23 hypoglycemic events per 1 year
Standard Deviation 32.99
|
16.23 hypoglycemic events per 1 year
Standard Deviation 26.05
|
|
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Nocturnal Hypoglycemic Rate
|
6.32 hypoglycemic events per 1 year
Standard Deviation 12.11
|
3.75 hypoglycemic events per 1 year
Standard Deviation 13.18
|
|
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Severe Hypoglycemic Rate
|
0.05 hypoglycemic events per 1 year
Standard Deviation 0.45
|
0.01 hypoglycemic events per 1 year
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.
Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level \<7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value \<2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Hypoglycemic Rate
|
1.99 hypoglycemic events per 30 days
Standard Deviation 2.71
|
1.33 hypoglycemic events per 30 days
Standard Deviation 2.14
|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Nocturnal Hypoglycemic Rate
|
0.52 hypoglycemic events per 30 days
Standard Deviation 0.99
|
0.31 hypoglycemic events per 30 days
Standard Deviation 1.08
|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Severe Hypoglycemic Rate
|
0.00 hypoglycemic events per 30 days
Standard Deviation 0.04
|
0.00 hypoglycemic events per 30 days
Standard Deviation 0.01
|
SECONDARY outcome
Timeframe: Baseline, 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=209 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Baseline
|
81.10 kilograms (kg)
Standard Deviation 17.46
|
82.56 kilograms (kg)
Standard Deviation 19.22
|
|
Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Change from Baseline
|
1.88 kilograms (kg)
Standard Deviation 3.16
|
0.36 kilograms (kg)
Standard Deviation 2.85
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.
Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Total Daily Insulin Dose (Units) at Endpoint
|
31.78 Units of insulin
Standard Deviation 19.14
|
37.30 Units of insulin
Standard Deviation 29.45
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.
Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
|
0.39 Units of Insulin/kilograms (U/kg)
Standard Deviation 0.23
|
0.46 Units of Insulin/kilograms (U/kg)
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.
Outcome measures
| Measure |
Insulin Lispro Protamine Suspension
n=219 Participants
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 Participants
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Number of Injections of Basal Insulin Analog at Endpoint
Patients with 1 Injection
|
89 participants
|
108 participants
|
|
Number of Injections of Basal Insulin Analog at Endpoint
Patients with 2 Injections
|
130 participants
|
102 participants
|
Adverse Events
Insulin Lispro Protamine Suspension
Serious events: 7 serious events
Other events: 78 other events
Deaths: 0 deaths
Detemir
Serious events: 1 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro Protamine Suspension
n=219 participants at risk
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 participants at risk
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.46%
1/219 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Cellulitis
|
0.00%
0/219
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.46%
1/219 • Number of events 1
|
0.00%
0/210
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.46%
1/219 • Number of events 1
|
0.00%
0/210
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.46%
1/219 • Number of events 1
|
0.00%
0/210
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.91%
2/219 • Number of events 4
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.46%
1/219 • Number of events 1
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.46%
1/219 • Number of events 1
|
0.00%
0/210
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.46%
1/219 • Number of events 1
|
0.00%
0/210
|
Other adverse events
| Measure |
Insulin Lispro Protamine Suspension
n=219 participants at risk
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Detemir
n=210 participants at risk
Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
|
|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
1.8%
4/219 • Number of events 4
|
0.95%
2/210 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
6/219 • Number of events 8
|
3.3%
7/210 • Number of events 7
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
5/219 • Number of events 5
|
0.95%
2/210 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.91%
2/219 • Number of events 4
|
1.9%
4/210 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
4/219 • Number of events 4
|
0.95%
2/210 • Number of events 2
|
|
General disorders
Chest pain
|
0.46%
1/219 • Number of events 1
|
1.4%
3/210 • Number of events 3
|
|
General disorders
Oedema peripheral
|
1.4%
3/219 • Number of events 3
|
0.48%
1/210 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/219
|
1.4%
3/210 • Number of events 3
|
|
General disorders
Pyrexia
|
2.3%
5/219 • Number of events 5
|
0.48%
1/210 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.91%
2/219 • Number of events 3
|
1.4%
3/210 • Number of events 3
|
|
Infections and infestations
Gastroenteritis
|
1.8%
4/219 • Number of events 4
|
0.48%
1/210 • Number of events 1
|
|
Infections and infestations
Influenza
|
1.8%
4/219 • Number of events 4
|
1.4%
3/210 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
12/219 • Number of events 14
|
4.8%
10/210 • Number of events 10
|
|
Infections and infestations
Sinusitis
|
1.4%
3/219 • Number of events 3
|
0.00%
0/210
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
6/219 • Number of events 7
|
3.3%
7/210 • Number of events 8
|
|
Investigations
Weight increased
|
2.3%
5/219 • Number of events 5
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.46%
1/219 • Number of events 1
|
1.4%
3/210 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
3/219 • Number of events 3
|
1.4%
3/210 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
3/219 • Number of events 3
|
1.4%
3/210 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
0.91%
2/219 • Number of events 2
|
1.9%
4/210 • Number of events 7
|
|
Nervous system disorders
Headache
|
2.3%
5/219 • Number of events 6
|
3.8%
8/210 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
3/219 • Number of events 3
|
1.4%
3/210 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.46%
1/219 • Number of events 1
|
1.9%
4/210 • Number of events 4
|
|
Vascular disorders
Hypertension
|
1.8%
4/219 • Number of events 4
|
1.4%
3/210 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60