Diabetes Mellitus, Type 2
Conditions
Keywords
diabetes, type 2
Brief summary
Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.
Interventions
DRUGInsulin Biphasic Aspart 30/70
Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
DRUGinsulin lispro LM
Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.
DRUGinsulin lispro MM
Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Have type 2 diabetes (World Health Organization \[WHO\] classification). * Are at least 30 years of age and less than 75 years of age. * Have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro LM or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 milligrams (mg) of metformin per day for at least 60 days immediately prior to the study. * Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1 or * Have at least 6 of 9 of the postprandial blood glucose values recorded in the period between Visit 1 and Visit 2 exceeding 180 milligrams per 100 milliliters (mg/dl) (10.0 millimole per liter \[mmol/l\]). * Have given written informed consent to participate in this study in accordance with local regulations.
Exclusion criteria
* Are taking any other oral anti-diabetic medication (OAM) not mentioned in inclusion criterion. * Have a body mass index greater than 40 kilograms per meter squared (kg/m2). * Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study. * Have congestive heart failure. * Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (HbA1c) at 16 Week Endpoint | 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint | Baseline, 16 Weeks | — |
| 2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint | 16 weeks | 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. |
| Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint | 16 weeks | 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. |
| Mean Daily Blood Glucose Values at 16 Week Endpoint | 16 weeks | — |
| Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint | 16 weeks | — |
| 30-Day Adjusted Rate of Hypoglycemic Events | Baseline through 16 weeks | 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. |
| Change From Baseline in Weight at 16 Week Endpoint | Baseline, 16 weeks | — |
| Total Daily Insulin Dose at 4 Weeks and 12 Weeks | 4 weeks and 12 weeks | — |
| Number of Patients With Self-reported Hypoglycemic Episodes | Baseline through 16 weeks | 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. |
Countries
Croatia, Poland, Romania, South Africa, Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 151 |
| 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. | 151 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Entry Criteria Not Met | 10 | 10 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Protocol Violation | 4 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Insulin Lispro LM + Insulin Lispro MM | Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Total |
|---|---|---|---|
| Age Continuous | 57.0 years STANDARD_DEVIATION 9.5 | 58.4 years STANDARD_DEVIATION 9.01 | 57.7 years STANDARD_DEVIATION 9.27 |
| Body Mass Index (BMI) | 32.3 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.11 | 31.0 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.27 | 31.7 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.23 |
| 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 | 44.0 International Units (IU) STANDARD_DEVIATION 17.79 | 45.7 International Units (IU) STANDARD_DEVIATION 19.09 |
| 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 | 39.7 International Units (IU) STANDARD_DEVIATION 13.79 | 42.9 International Units (IU) STANDARD_DEVIATION 15.69 |
| Daily Dose of Metformin Treatment Prior to Study (milligrams [mg]) | 1898.8 milligrams (mg) STANDARD_DEVIATION 402.99 | 1863.9 milligrams (mg) STANDARD_DEVIATION 379 | 1881.4 milligrams (mg) STANDARD_DEVIATION 390.92 |
| Duration of Antihyperglycaemic Therapy Prior to Study Insulin Treatment | 42.8 months STANDARD_DEVIATION 41.65 | 43.7 months STANDARD_DEVIATION 51.5 | 43.3 months STANDARD_DEVIATION 46.76 |
| Duration of Antihyperglycaemic Therapy Prior to Study Oral Hypoglycemic Treatment | 54.7 months STANDARD_DEVIATION 56.55 | 58.9 months STANDARD_DEVIATION 64.56 | 56.8 months STANDARD_DEVIATION 60.62 |
| Duration of Antihyperglycaemic Therapy Prior to Study Premixed Insulin Analogue Treatment | 16.4 months STANDARD_DEVIATION 17.61 | 16.1 months STANDARD_DEVIATION 22.42 | 16.3 months STANDARD_DEVIATION 20.12 |
| Duration of Diabetes | 10.9 years STANDARD_DEVIATION 5.66 | 11.5 years STANDARD_DEVIATION 7.19 | 11.2 years STANDARD_DEVIATION 6.47 |
| Fasting Plasma Glucose | 182.6 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 46.15 | 185.4 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 59.22 | 184.0 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 53.04 |
| Height | 165.4 centimeters (cm) STANDARD_DEVIATION 9.47 | 165.4 centimeters (cm) STANDARD_DEVIATION 9.82 | 165.4 centimeters (cm) STANDARD_DEVIATION 9.63 |
| Hemoglobin A1c (HbA1c) | 8.6 percent HbA1c STANDARD_DEVIATION 1.27 | 8.5 percent HbA1c STANDARD_DEVIATION 1.2 | 8.5 percent HbA1c STANDARD_DEVIATION 1.23 |
| Race/Ethnicity, Customized African | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Caucasian | 150 participants | 149 participants | 299 participants |
| Region of Enrollment Croatia | 7 participants | 11 participants | 18 participants |
| Region of Enrollment Hungary | 29 participants | 21 participants | 50 participants |
| Region of Enrollment Poland | 33 participants | 33 participants | 66 participants |
| Region of Enrollment Romania | 37 participants | 28 participants | 65 participants |
| Region of Enrollment South Africa | 12 participants | 13 participants | 25 participants |
| Region of Enrollment Turkey | 33 participants | 45 participants | 78 participants |
| Sex: Female, Male Female | 92 Participants | 82 Participants | 174 Participants |
| Sex: Female, Male Male | 59 Participants | 69 Participants | 128 Participants |
| Weight | 88.6 kilograms (kg) STANDARD_DEVIATION 14.97 | 85.1 kilograms (kg) STANDARD_DEVIATION 14.45 | 86.8 kilograms (kg) STANDARD_DEVIATION 14.79 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 139 | 26 / 139 |
| serious Total, serious adverse events | 3 / 139 | 7 / 139 |
Outcome results
Primary
Hemoglobin A1c (HbA1c) at 16 Week Endpoint
Time frame: 16 weeks
Population: Number of patients who received at least one dose of study drug and had an HbA1c measure at endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | Hemoglobin A1c (HbA1c) at 16 Week Endpoint | 7.71 percent HbA1c | Standard Deviation 1.098 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Hemoglobin A1c (HbA1c) at 16 Week Endpoint | 7.84 percent HbA1c | Standard Deviation 1.036 |
p-value: 0.2519ANCOVA
Secondary
2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint
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.
Time frame: 16 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | 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 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | 2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint | 178.2 milligrams per deciliter (mg/dL) | Standard Deviation 48.54 |
p-value: 0.0077ANCOVA
Secondary
30-Day Adjusted Rate of Hypoglycemic Events
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.
Time frame: Baseline through 16 weeks
Population: Number of patients who received at least one dose of study drug and had at least one assessment after randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | 30-Day Adjusted Rate of Hypoglycemic Events | Total Hypoglycemic Episodes/30 Days | 0.52 number of events per 30 days | Standard Deviation 1.212 |
| Insulin Lispro LM + Insulin Lispro MM | 30-Day Adjusted Rate of Hypoglycemic Events | Nocturnal Hypoglycemic Episodes/30 Days | 0.04 number of events per 30 days | Standard Deviation 0.138 |
| Insulin Lispro LM + Insulin Lispro MM | 30-Day Adjusted Rate of Hypoglycemic Events | Severe Hypoglycemic Episodes/30 Days | 0.01 number of events per 30 days | Standard Deviation 0.046 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | 30-Day Adjusted Rate of Hypoglycemic Events | Total Hypoglycemic Episodes/30 Days | 0.64 number of events per 30 days | Standard Deviation 1.398 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | 30-Day Adjusted Rate of Hypoglycemic Events | Nocturnal Hypoglycemic Episodes/30 Days | 0.12 number of events per 30 days | Standard Deviation 0.361 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | 30-Day Adjusted Rate of Hypoglycemic Events | Severe Hypoglycemic Episodes/30 Days | 0 number of events per 30 days | Standard Deviation 0.045 |
p-value: 0.723ANCOVA
p-value: 0.0063ANCOVA
p-value: 0.8876ANCOVA
Secondary
Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint
Time frame: Baseline, 16 Weeks
Population: Number of patients who received at least one dose of study drug and a post-baseline HbA1c value at endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint | -1.00 percent HbA1c | Standard Deviation 1.019 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint | -0.82 percent HbA1c | Standard Deviation 0.97 |
Secondary
Change From Baseline in Weight at 16 Week Endpoint
Time frame: Baseline, 16 weeks
Population: Number of patients who received at least one dose of study drug and had at least one post-baseline weight value at week 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | Change From Baseline in Weight at 16 Week Endpoint | 1.3 kilograms (kg) | Standard Deviation 2.73 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Change From Baseline in Weight at 16 Week Endpoint | 0.4 kilograms (kg) | Standard Deviation 2.45 |
p-value: 0.0009ANCOVA
Secondary
Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint
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.
Time frame: 16 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | 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 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint | 36.1 milligrams per deciliter (mg/dL) | Standard Deviation 48.2 |
p-value: 0.0002ANCOVA
Secondary
Mean Daily Blood Glucose Values at 16 Week Endpoint
Time frame: 16 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | Mean Daily Blood Glucose Values at 16 Week Endpoint | Pre-Lunch | 146.3 milligrams per deciliter (mg/dL) | Standard Deviation 34.75 |
| Insulin Lispro LM + Insulin Lispro MM | Mean Daily Blood Glucose Values at 16 Week Endpoint | Pre-Dinner | 157.5 milligrams per deciliter (mg/dL) | Standard Deviation 41.28 |
| Insulin Lispro LM + Insulin Lispro MM | Mean Daily Blood Glucose Values at 16 Week Endpoint | Fasting | 161.1 milligrams per deciliter (mg/dL) | Standard Deviation 35.41 |
| Insulin Lispro LM + Insulin Lispro MM | Mean Daily Blood Glucose Values at 16 Week Endpoint | 2-Hours After Dinner | 166.4 milligrams per deciliter (mg/dL) | Standard Deviation 44.13 |
| Insulin Lispro LM + Insulin Lispro MM | Mean Daily Blood Glucose Values at 16 Week Endpoint | 2-Hours After Lunch | 163.4 milligrams per deciliter (mg/dL) | Standard Deviation 40.85 |
| Insulin Lispro LM + Insulin Lispro MM | Mean Daily Blood Glucose Values at 16 Week Endpoint | 3:00 A.M. | 141.2 milligrams per deciliter (mg/dL) | Standard Deviation 32.19 |
| Insulin Lispro LM + Insulin Lispro MM | Mean Daily Blood Glucose Values at 16 Week Endpoint | 2-Hours After Breakfast | 179.0 milligrams per deciliter (mg/dL) | Standard Deviation 46.14 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Mean Daily Blood Glucose Values at 16 Week Endpoint | 3:00 A.M. | 141.0 milligrams per deciliter (mg/dL) | Standard Deviation 35.08 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Mean Daily Blood Glucose Values at 16 Week Endpoint | 2-Hours After Breakfast | 160.9 milligrams per deciliter (mg/dL) | Standard Deviation 45.25 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Mean Daily Blood Glucose Values at 16 Week Endpoint | Fasting | 153.9 milligrams per deciliter (mg/dL) | Standard Deviation 35.84 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Mean Daily Blood Glucose Values at 16 Week Endpoint | Pre-Lunch | 141.7 milligrams per deciliter (mg/dL) | Standard Deviation 41.72 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Mean Daily Blood Glucose Values at 16 Week Endpoint | 2-Hours After Lunch | 178.2 milligrams per deciliter (mg/dL) | Standard Deviation 48.54 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Mean Daily Blood Glucose Values at 16 Week Endpoint | Pre-Dinner | 165.7 milligrams per deciliter (mg/dL) | Standard Deviation 47.77 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Mean Daily Blood Glucose Values at 16 Week Endpoint | 2-Hours After Dinner | 171.4 milligrams per deciliter (mg/dL) | Standard Deviation 45.92 |
p-value: 0.0129ANCOVA
p-value: 0.0027ANCOVA
p-value: 0.1947ANCOVA
p-value: 0.0077ANCOVA
p-value: 0.1885ANCOVA
p-value: 0.5525ANCOVA
p-value: 0.4994ANCOVA
Secondary
Number of Patients With Self-reported Hypoglycemic Episodes
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.
Time frame: Baseline through 16 weeks
Population: Number of patients who received at least one dose of study drug and had at least one assessment after randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | Number of Patients With Self-reported Hypoglycemic Episodes | 1 Hypoglycemic Event | 24 participants |
| Insulin Lispro LM + Insulin Lispro MM | Number of Patients With Self-reported Hypoglycemic Episodes | 2 Hypoglycemic Events | 9 participants |
| Insulin Lispro LM + Insulin Lispro MM | Number of Patients With Self-reported Hypoglycemic Episodes | ≥3 Hypoglycemic Events | 24 participants |
| Insulin Lispro LM + Insulin Lispro MM | Number of Patients With Self-reported Hypoglycemic Episodes | 1 Nocturnal Hypoglycemic Event | 10 participants |
| Insulin Lispro LM + Insulin Lispro MM | Number of Patients With Self-reported Hypoglycemic Episodes | 2 Nocturnal Hypoglycemic Events | 3 participants |
| Insulin Lispro LM + Insulin Lispro MM | Number of Patients With Self-reported Hypoglycemic Episodes | ≥3 Nocturnal Hypoglycemic Events | 2 participants |
| Insulin Lispro LM + Insulin Lispro MM | Number of Patients With Self-reported Hypoglycemic Episodes | 1 Severe Hypoglycemic Event | 1 participants |
| Insulin Lispro LM + Insulin Lispro MM | Number of Patients With Self-reported Hypoglycemic Episodes | 2 Severe Hypoglycemic Events | 1 participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Number of Patients With Self-reported Hypoglycemic Episodes | 2 Severe Hypoglycemic Events | 1 participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Number of Patients With Self-reported Hypoglycemic Episodes | 1 Hypoglycemic Event | 14 participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Number of Patients With Self-reported Hypoglycemic Episodes | 2 Nocturnal Hypoglycemic Events | 3 participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Number of Patients With Self-reported Hypoglycemic Episodes | 2 Hypoglycemic Events | 11 participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Number of Patients With Self-reported Hypoglycemic Episodes | 1 Severe Hypoglycemic Event | 0 participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Number of Patients With Self-reported Hypoglycemic Episodes | ≥3 Hypoglycemic Events | 33 participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Number of Patients With Self-reported Hypoglycemic Episodes | ≥3 Nocturnal Hypoglycemic Events | 8 participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Number of Patients With Self-reported Hypoglycemic Episodes | 1 Nocturnal Hypoglycemic Event | 14 participants |
Secondary
Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint
Time frame: 16 weeks
Population: Number of patients who received at least one dose of study drug and had a post-baseline HbA1c value at endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint | HbA1c <7% | 21.4 percentage of participants |
| Insulin Lispro LM + Insulin Lispro MM | Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint | HbA1c ≤6.5% | 11.5 percentage of participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint | HbA1c <7% | 18.5 percentage of participants |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint | HbA1c ≤6.5% | 6.7 percentage of participants |
p-value: 0.0287Regression, Logistic
p-value: 0.0471Regression, Logistic
Secondary
Total Daily Insulin Dose at 4 Weeks and 12 Weeks
Time frame: 4 weeks and 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro LM + Insulin Lispro MM | 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 |
| Insulin Lispro LM + Insulin Lispro MM | 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 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Total Daily Insulin Dose at 4 Weeks and 12 Weeks | 4 Weeks (n=134, n=135) | 51.4 International Units (IU) | Standard Deviation 18.9 |
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Total Daily Insulin Dose at 4 Weeks and 12 Weeks | 12 Weeks (n=130, n=131) | 58.0 International Units (IU) | Standard Deviation 22.9 |
p-value: 0.0056ANCOVA
p-value: 0.0421ANCOVA