Trial Outcomes & Findings for A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients (NCT NCT00971997)
NCT ID: NCT00971997
Last Updated: 2012-04-11
Results Overview
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.
COMPLETED
PHASE4
135 participants
Week 48
2012-04-11
Participant Flow
Participant milestones
| Measure |
Lispro 50/50
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|
|
Overall Study
STARTED
|
135
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Lispro 50/50
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Physician Decision
|
7
|
Baseline Characteristics
A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients
Baseline characteristics by cohort
| Measure |
Lispro 50/50
n=135 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|
|
Age Continuous
|
60.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
135 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
135 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Participants received at least one dose of the study drug.
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.
Outcome measures
| Measure |
Lispro 50/50
n=135 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint
|
18.5 percentage of participants
Interval 12.4 to 26.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16 and Week 32Population: Participants received at least one dose of the study drug.
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.
Outcome measures
| Measure |
Lispro 50/50
n=135 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints
Week 16
|
6.7 percentage of participants
Interval 3.1 to 12.3
|
—
|
—
|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints
Week 32
|
20.0 percentage of participants
Interval 13.6 to 27.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16 and Week 32 and Week 48Population: Participants received at least one dose of the study drug.
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 7.0% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 7.4%.
Outcome measures
| Measure |
Lispro 50/50
n=135 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints
Week 16
|
22.2 percentage of participants
Interval 15.5 to 30.2
|
—
|
—
|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints
Week 32
|
43.0 percentage of participants
Interval 34.5 to 51.8
|
—
|
—
|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints
Week 48
|
52.6 percentage of participants
Interval 43.8 to 61.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Participants completed treatment through Week 48.
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. 6.5% and 7.0% HbA1c are the Japan Diabetes Society (JDS) values, and are equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c values of 6.9% and 7.4%, respectively.
Outcome measures
| Measure |
Lispro 50/50
n=9 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
n=21 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
n=86 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint
Below 6.5%
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
61.9 percentage of participants
Interval 38.4 to 81.9
|
11.6 percentage of participants
Interval 5.7 to 20.3
|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint
Below 7.0%
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
95.2 percentage of participants
Interval 76.2 to 99.9
|
51.2 percentage of participants
Interval 40.1 to 62.1
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants received at least one dose of the study drug, and had both baseline and post-baseline values.
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
Lispro 50/50
n=134 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint
|
-1.27 percentage of glycosylated hemoglobin
Standard Deviation 0.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants received at least one dose of the study drug, and had both baseline and post-baseline values.
Outcome measures
| Measure |
Lispro 50/50
n=131 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Change From Baseline in Fasting Glucose at Week 48 Endpoint
|
-19.9 milligram/deciliter (mg/dL)
Standard Deviation 48.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants received at least one dose of the study drug, and had both baseline and post-baseline values.
Time course of changes in blood glucose was determined by 7-point self-monitoring of blood glucose (SMBG) during the day (before breakfast, lunch, and dinner, 2 hours after the start of each meal, and at bedtime).
Outcome measures
| Measure |
Lispro 50/50
n=116 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Change From Baseline in Blood Glucose Profile at Week 48 Endpoint
Before breakfast (n=100)
|
-25.4 mg/dL
Standard Deviation 55.0
|
—
|
—
|
|
Change From Baseline in Blood Glucose Profile at Week 48 Endpoint
After breakfast (n=98)
|
-58.6 mg/dL
Standard Deviation 87.6
|
—
|
—
|
|
Change From Baseline in Blood Glucose Profile at Week 48 Endpoint
Before lunch (n=100)
|
-40.6 mg/dL
Standard Deviation 73.1
|
—
|
—
|
|
Change From Baseline in Blood Glucose Profile at Week 48 Endpoint
After lunch (n=99)
|
-44.0 mg/dL
Standard Deviation 84.5
|
—
|
—
|
|
Change From Baseline in Blood Glucose Profile at Week 48 Endpoint
Before dinner (n=100)
|
-40.0 mg/dL
Standard Deviation 76.8
|
—
|
—
|
|
Change From Baseline in Blood Glucose Profile at Week 48 Endpoint
After dinner (n=97)
|
-55.9 mg/dL
Standard Deviation 96.7
|
—
|
—
|
|
Change From Baseline in Blood Glucose Profile at Week 48 Endpoint
Bedtime (n=91)
|
-56.6 mg/dL
Standard Deviation 75.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants received at least one dose of the study drug, and had both baseline and post-baseline values.
C-peptide is a protein that is produced in the body along with insulin.
Outcome measures
| Measure |
Lispro 50/50
n=131 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint
|
-0.339 nanogram/milliliter (ng/mL)
Standard Deviation 0.739
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants received at least one dose of the study drug, and had both baseline and post-baseline values.
Outcome measures
| Measure |
Lispro 50/50
n=135 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint
Total cholesterol (n=131)
|
1.6 mg/dL
Standard Deviation 25.2
|
—
|
—
|
|
Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint
High-density lipoprotein (HDL) cholesterol (n=130)
|
2.44 mg/dL
Standard Deviation 8.66
|
—
|
—
|
|
Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint
Triglycerides (n=131)
|
-0.5 mg/dL
Standard Deviation 70.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants who completed treatment through Week 48, and had both baseline and post-baseline value.
Outcome measures
| Measure |
Lispro 50/50
n=116 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Change From Baseline in Body Weight at Week 48 Endpoint
|
1.51 kilogram (kg)
Standard Deviation 3.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 16, 32 and 48Population: Participants who completed treatment through Week 48.
Outcome measures
| Measure |
Lispro 50/50
n=116 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48
Baseline
|
4.34 units of insulin/day
Standard Deviation 1.35
|
—
|
—
|
|
Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48
Week 16
|
9.94 units of insulin/day
Standard Deviation 4.91
|
—
|
—
|
|
Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48
Week 32
|
15.92 units of insulin/day
Standard Deviation 10.01
|
—
|
—
|
|
Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48
Week 48
|
19.42 units of insulin/day
Standard Deviation 13.64
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 48Population: Participants received at least one dose of the study drug.
Results are reported as the percentage of participants experiencing hypoglycemia, which was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or they had a blood glucose level below 50 milligram/deciliter (mg/dL) regardless of signs, symptoms or the relationship to treatment.
Outcome measures
| Measure |
Lispro 50/50
n=135 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Percentage of Participants Developing Hypoglycemia at Any Time From Baseline Through Week 48
|
65.9 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 48Population: Participants received at least one dose of the study drug.
A hypoglycemic episode was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or participants had a blood glucose level below 50 mg/dL regardless of signs, symptoms or the relationship to treatment.
Outcome measures
| Measure |
Lispro 50/50
n=135 Participants
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Twice Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
Lispro 50/50 Three Times Daily
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|---|---|
|
Number of Hypoglycemia Episodes Participants Experienced at Any Time From Baseline Through Week 48
|
535 number of hypoglycemic episodes
|
—
|
—
|
Adverse Events
Lispro 50/50
Serious adverse events
| Measure |
Lispro 50/50
n=135 participants at risk
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.5%
2/135 • Number of events 2
|
|
Cardiac disorders
Cardiac failure chronic
|
0.74%
1/135 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.74%
1/135 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.74%
1/135 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.74%
1/135 • Number of events 1
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.74%
1/135 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.74%
1/135 • Number of events 1
|
Other adverse events
| Measure |
Lispro 50/50
n=135 participants at risk
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
|
|---|---|
|
Eye disorders
Diabetic retinopathy
|
5.9%
8/135 • Number of events 8
|
|
Gastrointestinal disorders
Constipation
|
5.9%
8/135 • Number of events 9
|
|
Immune system disorders
Seasonal allergy
|
4.4%
6/135 • Number of events 6
|
|
Infections and infestations
Gastroenteritis
|
3.7%
5/135 • Number of events 6
|
|
Infections and infestations
Nasopharyngitis
|
32.6%
44/135 • Number of events 58
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
8/135 • Number of events 8
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
8/135 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
5/135 • Number of events 5
|
|
Nervous system disorders
Hypoaesthesia
|
3.7%
5/135 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.4%
6/135 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.9%
12/135 • Number of events 13
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60