Trial Outcomes & Findings for A Study for Patients With Diabetes Mellitus (IOPA) (NCT NCT00420095)
NCT ID: NCT00420095
Last Updated: 2009-06-17
Results Overview
Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.
COMPLETED
PHASE4
117 participants
Baseline and 12 weeks of each treatment
2009-06-17
Participant Flow
Participant milestones
| Measure |
Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix
Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
|
Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70
Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
60
|
|
Overall Study
COMPLETED
|
54
|
59
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix
Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
|
Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70
Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study for Patients With Diabetes Mellitus (IOPA)
Baseline characteristics by cohort
| Measure |
Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix
n=57 Participants
Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
|
Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70
n=60 Participants
Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53.9 years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
57 participants
n=5 Participants
|
60 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Other Treatments for Diabetes Prior to Study
Yes
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Other Treatments for Diabetes Prior to Study
No
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Race/Ethnicity
Han - the main ethnic origin in China
|
57 participants
n=5 Participants
|
60 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Type of Diabetes
Type 1
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Type of Diabetes
Type 2
|
55 participants
n=5 Participants
|
53 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Baseline Fasting Blood Glucose
|
9.49 millimole/Liter
STANDARD_DEVIATION 2.660 • n=5 Participants
|
9.15 millimole/Liter
STANDARD_DEVIATION 3.200 • n=7 Participants
|
9.32 millimole/Liter
STANDARD_DEVIATION 2.942 • n=5 Participants
|
|
Baseline Glycosylated Hemoglobin
|
8.56 percent of glycosylated hemoglobin
STANDARD_DEVIATION 1.304 • n=5 Participants
|
8.59 percent of glycosylated hemoglobin
STANDARD_DEVIATION 1.573 • n=7 Participants
|
8.58 percent of glycosylated hemoglobin
STANDARD_DEVIATION 1.442 • n=5 Participants
|
|
Body Mass Index
|
25.40 kilogram per meter squared
STANDARD_DEVIATION 3.297 • n=5 Participants
|
24.58 kilogram per meter squared
STANDARD_DEVIATION 2.754 • n=7 Participants
|
24.98 kilogram per meter squared
STANDARD_DEVIATION 3.045 • n=5 Participants
|
|
Duration of Diabetes
|
129.8 months
STANDARD_DEVIATION 95.61 • n=5 Participants
|
130.3 months
STANDARD_DEVIATION 78.31 • n=7 Participants
|
130.1 months
STANDARD_DEVIATION 86.78 • n=5 Participants
|
|
Duration of Insulin Treatment
|
38.6 months
STANDARD_DEVIATION 37.41 • n=5 Participants
|
39.0 months
STANDARD_DEVIATION 32.37 • n=7 Participants
|
38.8 months
STANDARD_DEVIATION 34.77 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks of each treatmentPopulation: Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.
Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.
Outcome measures
| Measure |
Human Insulin Mix 30/70
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
Insulin Lispro Low Mix
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
|---|---|---|
|
Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint
|
7.91 percent of glycosylated hemoglobin
95% Confidence Interval 1.158 • Interval 7.67 to 8.15
|
7.96 percent of glycosylated hemoglobin
95% Confidence Interval 1.373 • Interval 7.72 to 8.2
|
SECONDARY outcome
Timeframe: Baseline and at 12 weeks of each treatmentPopulation: Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.
Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.
Outcome measures
| Measure |
Human Insulin Mix 30/70
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
Insulin Lispro Low Mix
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
|---|---|---|
|
Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment
|
0.68 percent of glycosylated hemoglobin
Interval 0.44 to 0.93
|
0.63 percent of glycosylated hemoglobin
Interval 0.38 to 0.88
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks of each treatmentPopulation: Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.
Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint
Outcome measures
| Measure |
Human Insulin Mix 30/70
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
Insulin Lispro Low Mix
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
|---|---|---|
|
Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment
|
1.04 millimoles/Liter
Interval 0.57 to 1.51
|
1.18 millimoles/Liter
Interval 0.71 to 1.65
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks of each treatmentPopulation: Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.
Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint
Outcome measures
| Measure |
Human Insulin Mix 30/70
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
Insulin Lispro Low Mix
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
|---|---|---|
|
Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment
|
-4.72 units of insulin
Interval -6.05 to -3.38
|
-4.56 units of insulin
Interval -5.89 to -3.23
|
SECONDARY outcome
Timeframe: 12 weeks of each treatmentPopulation: Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.
Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.
Outcome measures
| Measure |
Human Insulin Mix 30/70
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
Insulin Lispro Low Mix
n=113 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
|---|---|---|
|
Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%
HbA1c <=7%
|
26 participants
|
30 participants
|
|
Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%
HbA1c <=6.5%
|
11 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks of each treatmentPopulation: Includes all randomized patients receiving at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.
Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.
Outcome measures
| Measure |
Human Insulin Mix 30/70
n=116 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
Insulin Lispro Low Mix
n=114 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
|---|---|---|
|
Number of Participants With Laboratory Parameters Significantly Different From Baseline
Chemistry - Significantly Different from Baseline
|
0 participants
|
0 participants
|
|
Number of Participants With Laboratory Parameters Significantly Different From Baseline
Urinalysis - Significantly Different from Baseline
|
0 participants
|
0 participants
|
|
Number of Participants With Laboratory Parameters Significantly Different From Baseline
Hematology - Significantly Different from Baseline
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: over 12 weeks of each treatment periodPopulation: Includes all randomized patients who had at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.
Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) \* 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.
Outcome measures
| Measure |
Human Insulin Mix 30/70
n=116 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
Insulin Lispro Low Mix
n=114 Participants
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
|---|---|---|
|
Hypoglycemia Rate Per Participant Per 30 Days
|
0.34 events/30 days
Interval 0.19 to 0.49
|
0.37 events/30 days
Interval 0.22 to 0.52
|
Adverse Events
Human Insulin Mix 30/70
Insulin Lispro Low Mix
Serious adverse events
| Measure |
Human Insulin Mix 30/70
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
Insulin Lispro Low Mix
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Hypoglycemic coma
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
Other adverse events
| Measure |
Human Insulin Mix 30/70
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
Insulin Lispro Low Mix
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/116 • Number of events 3
|
3.5%
4/114 • Number of events 5
|
|
Infections and infestations
Urinary tract infection
|
1.7%
2/116 • Number of events 2
|
3.5%
4/114 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
5/116 • Number of events 5
|
0.00%
0/114
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/116
|
1.8%
2/114 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/116
|
2.6%
3/114 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
1.7%
2/116 • Number of events 2
|
0.00%
0/114
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Infections and infestations
Localised infection
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.86%
1/116 • Number of events 1
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Lacunar infarction
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Nervous system disorders
Migraine
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Investigations
Alanine aminotransferase increased
|
0.86%
1/116 • Number of events 1
|
0.88%
1/114 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Chest pain
|
0.86%
1/116 • Number of events 1
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.86%
1/116 • Number of events 1
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/116
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
|
Vascular disorders
Hypertension
|
0.86%
1/116 • Number of events 1
|
0.00%
0/114
|
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