Diabetes Mellitus, Type 2
Conditions
Keywords
Metabolic Diseases, Diabetes Mellitus, Type 2, Glargine, Diabetes Mellitus, Insulin LISPRO, Insulin
Brief summary
The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.
Interventions
DRUGInsulin Lispro Premix
Participant dependent dose, administered subcutaneously for 24 weeks
DRUGInsulin Glargine
Participant dependent dose, administered subcutaneously for 24 weeks
DRUGInsulin Lispro
Participant dependent dose, administered subcutaneously for 24 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Present with type 2 diabetes mellitus * Have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry * Have Haemoglobin A1c (HbA1c) \>7.0% and \<12.0%
Exclusion criteria
* Within the last 3 months prior to entry into the study, are taking any non-permitted glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic medications * Are pregnant or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. * Are women who are breastfeeding. * Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night). * Do not regularly consume three meals per day. * Have a body mass index \>35 kilogram per square meter (kg/m\^2). * Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study. * Have cardiac disease with a functional status that is Class III or IV * Have a history of renal or liver disease * Have used less than or equal to 20 Units per day (U/day) of insulin during the past 90 days for more than 14 days (accumulated).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint | Baseline, 24 weeks | Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks | 12 weeks, 24 weeks | The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (\<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal. |
| The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Baseline, 12 weeks, and 24 weeks | 7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour \[3 am\]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. |
| Daily Dose of Insulin: Total, Basal, and Prandial | 24 weeks | — |
| Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks | Baseline, 12 weeks, and 24 weeks | Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect. |
| Change in HbA1c From Baseline to 12 Week Endpoint | Baseline, 12 weeks | Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect. |
| Percentage of Participants With Hypoglycemic Episodes (Incidence) | baseline through 24 weeks | Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L). |
| The Rate of Hypoglycemic Episodes | baseline through 24 weeks | The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L). |
| Percentage of Participants Experiencing a Severe Hypoglycemic Episode | baseline through 24 weeks | Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug. |
| Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial | 24 weeks | — |
Countries
China, South Korea, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Premixed Insulin Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)
Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks | 199 |
| Basal-Bolus Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks | 203 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Entry criteria not met | 3 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 7 |
Baseline characteristics
| Characteristic | Basal-Bolus | Total | Premixed Insulin |
|---|---|---|---|
| Age Continuous | 58.1 years STANDARD_DEVIATION 9.05 | 58.6 years STANDARD_DEVIATION 9.17 | 59.0 years STANDARD_DEVIATION 9.29 |
| Race/Ethnicity, Customized Asian | 203 participants | 402 participants | 199 participants |
| Race/Ethnicity, Customized Non-Asian | 0 participants | 0 participants | 0 participants |
| Region of Enrollment China | 158 participants | 315 participants | 157 participants |
| Region of Enrollment Korea, Republic of | 25 participants | 49 participants | 24 participants |
| Region of Enrollment Taiwan | 20 participants | 38 participants | 18 participants |
| Sex: Female, Male Female | 93 Participants | 196 Participants | 103 Participants |
| Sex: Female, Male Male | 110 Participants | 206 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 197 | 60 / 202 |
| serious Total, serious adverse events | 13 / 197 | 8 / 202 |
Outcome results
Primary
Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Time frame: Baseline, 24 weeks
Population: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had at least 1 post-baseline evaluable HbA1c data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Premixed Insulin | Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint | -1.05 percent HbA1c |
| Basal-Bolus | Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint | -1.06 percent HbA1c |
95% CI: [-0.14, 0.16]
Secondary
Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks
Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had baseline and at least 1 post-baseline BMI data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Premixed Insulin | Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks | Change at 12 weeks | 0.26 kilogram per square meter (kg/m^2) |
| Premixed Insulin | Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks | Change at 24 weeks | 0.31 kilogram per square meter (kg/m^2) |
| Basal-Bolus | Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks | Change at 12 weeks | 0.20 kilogram per square meter (kg/m^2) |
| Basal-Bolus | Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks | Change at 24 weeks | 0.29 kilogram per square meter (kg/m^2) |
Secondary
Change in HbA1c From Baseline to 12 Week Endpoint
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Time frame: Baseline, 12 weeks
Population: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and who had a baseline and at least 1 post-baseline evaluable HbA1c data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Premixed Insulin | Change in HbA1c From Baseline to 12 Week Endpoint | -0.96 percent HbA1c |
| Basal-Bolus | Change in HbA1c From Baseline to 12 Week Endpoint | -0.96 percent HbA1c |
95% CI: [-0.15, 0.16]
Secondary
Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial
Time frame: 24 weeks
Population: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Premixed Insulin | Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial | Total Daily Dose | 0.738 International Units per kilogram (IU/kg) | Standard Deviation 0.2477 |
| Premixed Insulin | Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial | Daily Insulin Dose Basal | 0.440 International Units per kilogram (IU/kg) | Standard Deviation 0.1498 |
| Premixed Insulin | Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial | Daily Insulin Dose Bolus (prandial) | 0.298 International Units per kilogram (IU/kg) | Standard Deviation 0.0994 |
| Basal-Bolus | Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial | Total Daily Dose | 0.760 International Units per kilogram (IU/kg) | Standard Deviation 0.2694 |
| Basal-Bolus | Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial | Daily Insulin Dose Basal | 0.348 International Units per kilogram (IU/kg) | Standard Deviation 0.139 |
| Basal-Bolus | Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial | Daily Insulin Dose Bolus (prandial) | 0.412 International Units per kilogram (IU/kg) | Standard Deviation 0.1542 |
Secondary
Daily Dose of Insulin: Total, Basal, and Prandial
Time frame: 24 weeks
Population: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Premixed Insulin | Daily Dose of Insulin: Total, Basal, and Prandial | Total Daily Dose | 52.9 International Units (IU) | Standard Deviation 19.72 |
| Premixed Insulin | Daily Dose of Insulin: Total, Basal, and Prandial | Daily Insulin Dose Basal | 31.539 International Units (IU) | Standard Deviation 11.9288 |
| Premixed Insulin | Daily Dose of Insulin: Total, Basal, and Prandial | Daily Insulin Dose Bolus (prandial) | 21.385 International Units (IU) | Standard Deviation 7.8823 |
| Basal-Bolus | Daily Dose of Insulin: Total, Basal, and Prandial | Total Daily Dose | 54.0 International Units (IU) | Standard Deviation 19 |
| Basal-Bolus | Daily Dose of Insulin: Total, Basal, and Prandial | Daily Insulin Dose Basal | 24.717 International Units (IU) | Standard Deviation 9.9304 |
| Basal-Bolus | Daily Dose of Insulin: Total, Basal, and Prandial | Daily Insulin Dose Bolus (prandial) | 29.269 International Units (IU) | Standard Deviation 10.8353 |
Secondary
Percentage of Participants Experiencing a Severe Hypoglycemic Episode
Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug.
Time frame: baseline through 24 weeks
Population: Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Premixed Insulin | Percentage of Participants Experiencing a Severe Hypoglycemic Episode | 0.0 Percentage of participants |
| Basal-Bolus | Percentage of Participants Experiencing a Severe Hypoglycemic Episode | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Hypoglycemic Episodes (Incidence)
Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L).
Time frame: baseline through 24 weeks
Population: Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Premixed Insulin | Percentage of Participants With Hypoglycemic Episodes (Incidence) | 54.8 percentage of participants |
| Basal-Bolus | Percentage of Participants With Hypoglycemic Episodes (Incidence) | 55.0 percentage of participants |
Secondary
The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.
7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour \[3 am\]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning Pre-meal (Week 0) (n=195, 201) | 155.0 milligrams per deciliter (mg/dL) | Standard Deviation 34.89 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning Pre-meal (Week 12) (n=187, 191) | 141.8 milligrams per deciliter (mg/dL) | Standard Deviation 30.78 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning Pre-meal (Week 24) (n=177, 186) | 137.4 milligrams per deciliter (mg/dL) | Standard Deviation 24.96 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning 2 hours Post-meal (Week 0) (n=194, 201) | 207.1 milligrams per deciliter (mg/dL) | Standard Deviation 54.74 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning 2 hours Post-meal (Week 12) (n=187, 190) | 179.6 milligrams per deciliter (mg/dL) | Standard Deviation 46.17 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning 2 hours Post-meal (Week 24) (n=176, 184) | 169.7 milligrams per deciliter (mg/dL) | Standard Deviation 39.04 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday Pre-meal (Week 0) (n=195, 200) | 160.7 milligrams per deciliter (mg/dL) | Standard Deviation 47.89 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday Pre-meal (Week 12) (n=187, 190) | 142.5 milligrams per deciliter (mg/dL) | Standard Deviation 37.27 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday Pre-meal (Week 24) (n=177, 186) | 139.5 milligrams per deciliter (mg/dL) | Standard Deviation 31.05 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday 2 hours Post-meal (Week 0) (n=194, 201) | 219.7 milligrams per deciliter (mg/dL) | Standard Deviation 54.03 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday 2 hours Post-meal (Week 12) (n=186, 189) | 162.5 milligrams per deciliter (mg/dL) | Standard Deviation 41.53 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday 2 hours Post-meal (Week 24) (n=175, 184) | 161.9 milligrams per deciliter (mg/dL) | Standard Deviation 38.66 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening Pre-meal (Week 0) (n=195, 200) | 186.6 milligrams per deciliter (mg/dL) | Standard Deviation 44.97 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening Pre-meal (Week 12) (n=187, 190) | 148.1 milligrams per deciliter (mg/dL) | Standard Deviation 33.74 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening Pre-meal (Week 24) (n=177, 186) | 145.0 milligrams per deciliter (mg/dL) | Standard Deviation 30.67 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening 2 hours Post-meal (Week 0) (n=194, 201) | 204.8 milligrams per deciliter (mg/dL) | Standard Deviation 54.31 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening 2 hours Post-meal (Week 12) (n=186, 190) | 177.1 milligrams per deciliter (mg/dL) | Standard Deviation 45.29 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening 2 hours Post-meal (Week 24)(n=176, 185) | 172.0 milligrams per deciliter (mg/dL) | Standard Deviation 38.77 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | 0300 Hours (3 am) (Week 0) (n=185, 193) | 175.9 milligrams per deciliter (mg/dL) | Standard Deviation 51.97 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | 0300 Hours (3 am) (Week 12) (n=177, 185) | 150.3 milligrams per deciliter (mg/dL) | Standard Deviation 39.41 |
| Premixed Insulin | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | 0300 Hours (3 am) (Week 24) (n=171, 179) | 145.1 milligrams per deciliter (mg/dL) | Standard Deviation 31.45 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday 2 hours Post-meal (Week 12) (n=186, 189) | 177.2 milligrams per deciliter (mg/dL) | Standard Deviation 44.53 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning Pre-meal (Week 0) (n=195, 201) | 157.7 milligrams per deciliter (mg/dL) | Standard Deviation 38.81 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | 0300 Hours (3 am) (Week 0) (n=185, 193) | 180.0 milligrams per deciliter (mg/dL) | Standard Deviation 54.35 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning Pre-meal (Week 12) (n=187, 191) | 136.5 milligrams per deciliter (mg/dL) | Standard Deviation 31.44 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday 2 hours Post-meal (Week 24) (n=175, 184) | 171.1 milligrams per deciliter (mg/dL) | Standard Deviation 39.33 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning Pre-meal (Week 24) (n=177, 186) | 132.4 milligrams per deciliter (mg/dL) | Standard Deviation 25.17 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening 2 hours Post-meal (Week 12) (n=186, 190) | 176.2 milligrams per deciliter (mg/dL) | Standard Deviation 40.55 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning 2 hours Post-meal (Week 0) (n=194, 201) | 213.6 milligrams per deciliter (mg/dL) | Standard Deviation 53.95 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening Pre-meal (Week 0) (n=195, 200) | 190.0 milligrams per deciliter (mg/dL) | Standard Deviation 53.41 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning 2 hours Post-meal (Week 12) (n=187, 190) | 176.5 milligrams per deciliter (mg/dL) | Standard Deviation 43.69 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | 0300 Hours (3 am) (Week 24) (n=171, 179) | 155.8 milligrams per deciliter (mg/dL) | Standard Deviation 34.36 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Morning 2 hours Post-meal (Week 24) (n=176, 184) | 165.8 milligrams per deciliter (mg/dL) | Standard Deviation 35.77 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening Pre-meal (Week 12) (n=187, 190) | 157.6 milligrams per deciliter (mg/dL) | Standard Deviation 42 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday Pre-meal (Week 0) (n=195, 200) | 164.9 milligrams per deciliter (mg/dL) | Standard Deviation 48.71 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening 2 hours Post-meal (Week 24)(n=176, 185) | 165.6 milligrams per deciliter (mg/dL) | Standard Deviation 38.66 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday Pre-meal (Week 12) (n=187, 190) | 149.4 milligrams per deciliter (mg/dL) | Standard Deviation 41.58 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening Pre-meal (Week 24) (n=177, 186) | 151.1 milligrams per deciliter (mg/dL) | Standard Deviation 33.36 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday Pre-meal (Week 24) (n=177, 186) | 142.1 milligrams per deciliter (mg/dL) | Standard Deviation 32.73 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | 0300 Hours (3 am) (Week 12) (n=177, 185) | 163.6 milligrams per deciliter (mg/dL) | Standard Deviation 42.42 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Midday 2 hours Post-meal (Week 0) (n=194, 201) | 227.5 milligrams per deciliter (mg/dL) | Standard Deviation 54.56 |
| Basal-Bolus | The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks. | Evening 2 hours Post-meal (Week 0) (n=194, 201) | 209.9 milligrams per deciliter (mg/dL) | Standard Deviation 58.59 |
Secondary
The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks
The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (\<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal.
Time frame: 12 weeks, 24 weeks
Population: Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Premixed Insulin | The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks | <=6.5 Percent HbA1c at 12 weeks | 6.1 Percentage of participants |
| Premixed Insulin | The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks | <=7.0 Percent HbA1c at 12 weeks | 26.4 Percentage of participants |
| Premixed Insulin | The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks | <=6.5 Percent HbA1c at 24 weeks | 9.1 Percentage of participants |
| Premixed Insulin | The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks | <=7.0 Percent HbA1c at 24 weeks | 29.9 Percentage of participants |
| Basal-Bolus | The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks | <=7.0 Percent HbA1c at 24 weeks | 34.2 Percentage of participants |
| Basal-Bolus | The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks | <=6.5 Percent HbA1c at 12 weeks | 8.9 Percentage of participants |
| Basal-Bolus | The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks | <=6.5 Percent HbA1c at 24 weeks | 11.9 Percentage of participants |
| Basal-Bolus | The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks | <=7.0 Percent HbA1c at 12 weeks | 27.7 Percentage of participants |
p-value: 0.344Fisher Exact
p-value: 0.822Fisher Exact
p-value: 0.417Fisher Exact
p-value: 0.392Fisher Exact
Secondary
The Rate of Hypoglycemic Episodes
The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L).
Time frame: baseline through 24 weeks
Population: Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Premixed Insulin | The Rate of Hypoglycemic Episodes | 0.468 hypoglycemic episode/30 days/participant | Standard Error 1.0417 |
| Basal-Bolus | The Rate of Hypoglycemic Episodes | 0.409 hypoglycemic episode/30 days/participant | Standard Error 0.6668 |