Trial Outcomes & Findings for Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019) (NCT NCT00393705)
NCT ID: NCT00393705
Last Updated: 2010-07-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
302 participants
Primary outcome timeframe
16 weeks
Results posted on
2010-07-20
Participant Flow
Participant milestones
| Measure |
Insulin Lispro LM + Insulin Lispro MM
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
151
|
|
Overall Study
Received at Least One Dose of Study Drug
|
139
|
139
|
|
Overall Study
COMPLETED
|
128
|
128
|
|
Overall Study
NOT COMPLETED
|
23
|
23
|
Reasons for withdrawal
| Measure |
Insulin Lispro LM + Insulin Lispro MM
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Entry Criteria Not Met
|
10
|
10
|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Physician Decision
|
2
|
2
|
Baseline Characteristics
Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)
Baseline characteristics by cohort
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=151 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=151 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.0 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 9.01 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
150 participants
n=5 Participants
|
149 participants
n=7 Participants
|
299 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
33 participants
n=5 Participants
|
45 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
37 participants
n=5 Participants
|
28 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
29 participants
n=5 Participants
|
21 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
32.3 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.11 • n=5 Participants
|
31.0 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.27 • n=7 Participants
|
31.7 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.23 • n=5 Participants
|
|
Daily Dose of Antihyperglycaemic Therapy Prior to Study (International Units [IU])
Insulin Lispro Dose (n=61, n=57)
|
45.8 International Units (IU)
STANDARD_DEVIATION 16.87 • n=5 Participants
|
39.7 International Units (IU)
STANDARD_DEVIATION 13.79 • n=7 Participants
|
42.9 International Units (IU)
STANDARD_DEVIATION 15.69 • n=5 Participants
|
|
Daily Dose of Antihyperglycaemic Therapy Prior to Study (International Units [IU])
Biphasic Insulin Aspart 30/70 Dose (n=90, n=94)
|
47.5 International Units (IU)
STANDARD_DEVIATION 20.31 • n=5 Participants
|
44.0 International Units (IU)
STANDARD_DEVIATION 17.79 • n=7 Participants
|
45.7 International Units (IU)
STANDARD_DEVIATION 19.09 • n=5 Participants
|
|
Daily Dose of Metformin Treatment Prior to Study (milligrams [mg])
|
1898.8 milligrams (mg)
STANDARD_DEVIATION 402.99 • n=5 Participants
|
1863.9 milligrams (mg)
STANDARD_DEVIATION 379.00 • n=7 Participants
|
1881.4 milligrams (mg)
STANDARD_DEVIATION 390.92 • n=5 Participants
|
|
Duration of Antihyperglycaemic Therapy Prior to Study
Insulin Treatment
|
42.8 months
STANDARD_DEVIATION 41.65 • n=5 Participants
|
43.7 months
STANDARD_DEVIATION 51.50 • n=7 Participants
|
43.3 months
STANDARD_DEVIATION 46.76 • n=5 Participants
|
|
Duration of Antihyperglycaemic Therapy Prior to Study
Premixed Insulin Analogue Treatment
|
16.4 months
STANDARD_DEVIATION 17.61 • n=5 Participants
|
16.1 months
STANDARD_DEVIATION 22.42 • n=7 Participants
|
16.3 months
STANDARD_DEVIATION 20.12 • n=5 Participants
|
|
Duration of Antihyperglycaemic Therapy Prior to Study
Oral Hypoglycemic Treatment
|
54.7 months
STANDARD_DEVIATION 56.55 • n=5 Participants
|
58.9 months
STANDARD_DEVIATION 64.56 • n=7 Participants
|
56.8 months
STANDARD_DEVIATION 60.62 • n=5 Participants
|
|
Duration of Diabetes
|
10.9 years
STANDARD_DEVIATION 5.66 • n=5 Participants
|
11.5 years
STANDARD_DEVIATION 7.19 • n=7 Participants
|
11.2 years
STANDARD_DEVIATION 6.47 • n=5 Participants
|
|
Fasting Plasma Glucose
|
182.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 46.15 • n=5 Participants
|
185.4 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 59.22 • n=7 Participants
|
184.0 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 53.04 • n=5 Participants
|
|
Height
|
165.4 centimeters (cm)
STANDARD_DEVIATION 9.47 • n=5 Participants
|
165.4 centimeters (cm)
STANDARD_DEVIATION 9.82 • n=7 Participants
|
165.4 centimeters (cm)
STANDARD_DEVIATION 9.63 • n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.6 percent HbA1c
STANDARD_DEVIATION 1.27 • n=5 Participants
|
8.5 percent HbA1c
STANDARD_DEVIATION 1.20 • n=7 Participants
|
8.5 percent HbA1c
STANDARD_DEVIATION 1.23 • n=5 Participants
|
|
Weight
|
88.6 kilograms (kg)
STANDARD_DEVIATION 14.97 • n=5 Participants
|
85.1 kilograms (kg)
STANDARD_DEVIATION 14.45 • n=7 Participants
|
86.8 kilograms (kg)
STANDARD_DEVIATION 14.79 • n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Number of patients who received at least one dose of study drug and had an HbA1c measure at endpoint.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=131 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=135 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Hemoglobin A1c (HbA1c) at 16 Week Endpoint
|
7.71 percent HbA1c
Standard Deviation 1.098
|
7.84 percent HbA1c
Standard Deviation 1.036
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Number of patients who received at least one dose of study drug and had a post-baseline HbA1c value at endpoint.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=131 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=135 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint
HbA1c <7%
|
21.4 percentage of participants
|
18.5 percentage of participants
|
|
Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint
HbA1c ≤6.5%
|
11.5 percentage of participants
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksPopulation: Number of patients who received at least one dose of study drug and a post-baseline HbA1c value at endpoint.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=131 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=135 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint
|
-1.00 percent HbA1c
Standard Deviation 1.019
|
-0.82 percent HbA1c
Standard Deviation 0.970
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial plasma glucose reading after the midday meal at week 16.
Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=125 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=126 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint
|
163.4 milligrams per deciliter (mg/dL)
Standard Deviation 40.85
|
178.2 milligrams per deciliter (mg/dL)
Standard Deviation 48.54
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial blood glucose reading after the midday meal at week 16.
Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=125 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=127 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint
|
17.0 milligrams per deciliter (mg/dL)
Standard Deviation 36.42
|
36.1 milligrams per deciliter (mg/dL)
Standard Deviation 48.20
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Number of patients who received at least one dose of study drug and had a post-baseline blood glucose reading at week 16 for the respective variable.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=125 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=127 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Mean Daily Blood Glucose Values at 16 Week Endpoint
Fasting
|
161.1 milligrams per deciliter (mg/dL)
Standard Deviation 35.41
|
153.9 milligrams per deciliter (mg/dL)
Standard Deviation 35.84
|
|
Mean Daily Blood Glucose Values at 16 Week Endpoint
2-Hours After Breakfast
|
179.0 milligrams per deciliter (mg/dL)
Standard Deviation 46.14
|
160.9 milligrams per deciliter (mg/dL)
Standard Deviation 45.25
|
|
Mean Daily Blood Glucose Values at 16 Week Endpoint
Pre-Lunch
|
146.3 milligrams per deciliter (mg/dL)
Standard Deviation 34.75
|
141.7 milligrams per deciliter (mg/dL)
Standard Deviation 41.72
|
|
Mean Daily Blood Glucose Values at 16 Week Endpoint
2-Hours After Lunch
|
163.4 milligrams per deciliter (mg/dL)
Standard Deviation 40.85
|
178.2 milligrams per deciliter (mg/dL)
Standard Deviation 48.54
|
|
Mean Daily Blood Glucose Values at 16 Week Endpoint
Pre-Dinner
|
157.5 milligrams per deciliter (mg/dL)
Standard Deviation 41.28
|
165.7 milligrams per deciliter (mg/dL)
Standard Deviation 47.77
|
|
Mean Daily Blood Glucose Values at 16 Week Endpoint
2-Hours After Dinner
|
166.4 milligrams per deciliter (mg/dL)
Standard Deviation 44.13
|
171.4 milligrams per deciliter (mg/dL)
Standard Deviation 45.92
|
|
Mean Daily Blood Glucose Values at 16 Week Endpoint
3:00 A.M.
|
141.2 milligrams per deciliter (mg/dL)
Standard Deviation 32.19
|
141.0 milligrams per deciliter (mg/dL)
Standard Deviation 35.08
|
SECONDARY outcome
Timeframe: Baseline through 16 weeksPopulation: Number of patients who received at least one dose of study drug and had at least one assessment after randomization.
Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=139 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=139 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Number of Patients With Self-reported Hypoglycemic Episodes
1 Hypoglycemic Event
|
24 participants
|
14 participants
|
|
Number of Patients With Self-reported Hypoglycemic Episodes
2 Hypoglycemic Events
|
9 participants
|
11 participants
|
|
Number of Patients With Self-reported Hypoglycemic Episodes
≥3 Hypoglycemic Events
|
24 participants
|
33 participants
|
|
Number of Patients With Self-reported Hypoglycemic Episodes
1 Nocturnal Hypoglycemic Event
|
10 participants
|
14 participants
|
|
Number of Patients With Self-reported Hypoglycemic Episodes
2 Nocturnal Hypoglycemic Events
|
3 participants
|
3 participants
|
|
Number of Patients With Self-reported Hypoglycemic Episodes
≥3 Nocturnal Hypoglycemic Events
|
2 participants
|
8 participants
|
|
Number of Patients With Self-reported Hypoglycemic Episodes
1 Severe Hypoglycemic Event
|
1 participants
|
0 participants
|
|
Number of Patients With Self-reported Hypoglycemic Episodes
2 Severe Hypoglycemic Events
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through 16 weeksPopulation: Number of patients who received at least one dose of study drug and had at least one assessment after randomization.
Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=139 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=139 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
30-Day Adjusted Rate of Hypoglycemic Events
Total Hypoglycemic Episodes/30 Days
|
0.52 number of events per 30 days
Standard Deviation 1.212
|
0.64 number of events per 30 days
Standard Deviation 1.398
|
|
30-Day Adjusted Rate of Hypoglycemic Events
Nocturnal Hypoglycemic Episodes/30 Days
|
0.04 number of events per 30 days
Standard Deviation 0.138
|
0.12 number of events per 30 days
Standard Deviation 0.361
|
|
30-Day Adjusted Rate of Hypoglycemic Events
Severe Hypoglycemic Episodes/30 Days
|
0.01 number of events per 30 days
Standard Deviation 0.046
|
0 number of events per 30 days
Standard Deviation 0.045
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Number of patients who received at least one dose of study drug and had at least one post-baseline weight value at week 16.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=126 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=127 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Weight at 16 Week Endpoint
|
1.3 kilograms (kg)
Standard Deviation 2.73
|
0.4 kilograms (kg)
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: 4 weeks and 12 weeksPopulation: Number of patients who received at least one dose of study drug and had a post-baseline insulin measurement at week 4 and week 12.
Outcome measures
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=134 Participants
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=135 Participants
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Total Daily Insulin Dose at 4 Weeks and 12 Weeks
4 Weeks (n=134, n=135)
|
57.1 International Units (IU)
Standard Deviation 22.32
|
51.4 International Units (IU)
Standard Deviation 18.90
|
|
Total Daily Insulin Dose at 4 Weeks and 12 Weeks
12 Weeks (n=130, n=131)
|
64.4 International Units (IU)
Standard Deviation 25.63
|
58.0 International Units (IU)
Standard Deviation 22.90
|
Adverse Events
Insulin Lispro LM + Insulin Lispro MM
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
Serious events: 7 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=139 participants at risk
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=139 participants at risk
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/139
|
1.4%
2/139 • Number of events 2
|
|
Infections and infestations
Gangrene
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Vascular disorders
Essential hypertension
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
Other adverse events
| Measure |
Insulin Lispro LM + Insulin Lispro MM
n=139 participants at risk
Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.
Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening.
|
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
n=139 participants at risk
Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).
Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Ear and labyrinth disorders
Ear congestion
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Eye disorders
Vitreous haemorrhage
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Gastrointestinal disorders
Gingival pain
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
General disorders
Chest pain
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
General disorders
Oedema peripheral
|
1.4%
2/139 • Number of events 2
|
2.2%
3/139 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
2.2%
3/139 • Number of events 3
|
2.9%
4/139 • Number of events 4
|
|
Infections and infestations
Cystitis
|
0.00%
0/139
|
1.4%
2/139 • Number of events 3
|
|
Infections and infestations
Ear infection
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Infections and infestations
Gastroenteritis
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Infections and infestations
Genital candidiasis
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Infections and infestations
Influenza
|
1.4%
2/139 • Number of events 2
|
0.00%
0/139
|
|
Infections and infestations
Nail infection
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
6/139 • Number of events 6
|
5.0%
7/139 • Number of events 8
|
|
Infections and infestations
Oral herpes
|
0.00%
0/139
|
0.72%
1/139 • Number of events 2
|
|
Infections and infestations
Otitis externa
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Infections and infestations
Otitis media
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Infections and infestations
Respiratory tract infection
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.72%
1/139 • Number of events 1
|
1.4%
2/139 • Number of events 2
|
|
Infections and infestations
Viral infection
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.72%
1/139 • Number of events 2
|
0.00%
0/139
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
2/139 • Number of events 2
|
1.4%
2/139 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/139
|
1.4%
2/139 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Psychiatric disorders
Depression
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Psychiatric disorders
Insomnia
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Psychiatric disorders
Stress
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/139
|
0.72%
1/139 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Surgical and medical procedures
Dental care
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Surgical and medical procedures
Eye laser surgery
|
0.00%
0/139
|
1.4%
2/139 • Number of events 2
|
|
Surgical and medical procedures
Influenza immunisation
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/139
|
0.72%
1/139 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.72%
1/139 • Number of events 1
|
0.72%
1/139 • Number of events 1
|
|
Vascular disorders
Venous insufficiency
|
0.72%
1/139 • Number of events 1
|
0.00%
0/139
|
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