Type 2 Diabetes Mellitus
Conditions
Keywords
mid mixture insulin analog, basal insulin analog
Brief summary
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.
Interventions
DRUGInsulin Analog Mid Mixture
Administered SC
DRUGBasal Insulin Analog
Administered SC
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
* have type 2 diabetes as defined by World Health Organization (WHO) criteria * are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator * most recent HbA1c value ≥7.5% within 12 weeks of study entry * in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment * willing to start with insulin treatment
Exclusion criteria
* have a diagnosis of type 1 diabetes * have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time) * have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study * are pregnant or breastfeeding, or intend to become pregnant during the course of the study * are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) | Baseline, 24 Weeks | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve HbA1c <7% at Week 24 | 24 Weeks | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. |
| Percentage of Participants Who Achieve HbA1c <7% at Week 48 | 48 Weeks | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. |
| Change From Baseline to Week 24 in Venous Fasting Plasma Glucose | Baseline, 24 Weeks | Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate. |
| Change From Baseline to Week 48 in Venous Fasting Plasma Glucose | Baseline, 48 Weeks | Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate. |
| Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | Baseline, 24 Weeks | Fasting blood glucose (FBG) and post prandial glucose (PPG) \[pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)\] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate. |
| Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | Baseline, 48 Weeks | Fasting blood glucose (FBG) and post prandial glucose (PPG) \[pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)\] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate. |
| Total Daily Insulin Dose at Week 24 and 48 | 24 Weeks, 48 Weeks | Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48. |
| Change From Baseline to Week 48 in HbA1c | Baseline, 48 Weeks | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate. |
| Change From Baseline to Week 48 in Body Weight | Baseline, 48 Weeks | LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate. |
| Rate of Hypoglycemia at Week 24 and 48 | 24 Weeks, 48 Weeks | Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable. |
| Number of Participants With Insulin Treatment Change at Week 48 | Baseline through 48 Weeks | Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency. 1. Discontinuation: Defined as stopping insulin treatment for 30 days or more. 2. Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class. 3. Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group 4. Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD. |
| Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24 | 24 Weeks | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of \<7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate. |
| Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48 | 48 Weeks | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of \<7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate. |
| Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score | Baseline, 48 Weeks | The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect. |
| Change From Baseline to Week 24 in Body Weight | Baseline, 24 Weeks | LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insulin Analog Mid Mixture Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator. | 404 |
| Basal Insulin Analog Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator. | 410 |
| Total | 814 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 21 | 32 |
| Overall Study | Not recorded | 0 | 2 |
| Overall Study | Physician Decision | 3 | 2 |
| Overall Study | Screen failure-After randomization | 4 | 2 |
| Overall Study | Sponsor Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 38 | 45 |
Baseline characteristics
| Characteristic | Insulin Analog Mid Mixture | Basal Insulin Analog | Total |
|---|---|---|---|
| Age, Continuous | 57.8 Years STANDARD_DEVIATION 9.08 | 57.5 Years STANDARD_DEVIATION 9.29 | 57.6 Years STANDARD_DEVIATION 9.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 404 Participants | 410 Participants | 814 Participants |
| Hemoglobin A1c (HbA1c) | 9.937 Percentage of HbA1c STANDARD_DEVIATION 1.6509 | 9.696 Percentage of HbA1c STANDARD_DEVIATION 1.5619 | 9.816 Percentage of HbA1c STANDARD_DEVIATION 1.6104 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 404 Participants | 410 Participants | 814 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 404 Participants | 410 Participants | 814 Participants |
| Sex: Female, Male Female | 181 Participants | 177 Participants | 358 Participants |
| Sex: Female, Male Male | 223 Participants | 233 Participants | 456 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 404 | 1 / 410 |
| other Total, other adverse events | 105 / 404 | 101 / 410 |
| serious Total, serious adverse events | 45 / 404 | 43 / 410 |
Outcome results
Primary
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
Time frame: Baseline, 24 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Analog Mid Mixture | Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) | -2.158 Percentage of HbA1c | Standard Error 0.0675 |
| Basal Insulin Analog | Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) | -2.000 Percentage of HbA1c | Standard Error 0.0678 |
p-value: 0.100995% CI: [-0.346, 0.031]ANCOVA
Secondary
Change From Baseline to Week 24 in Body Weight
LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
Time frame: Baseline, 24 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Analog Mid Mixture | Change From Baseline to Week 24 in Body Weight | 1.226 kilograms (kg) | Standard Error 0.1976 |
| Basal Insulin Analog | Change From Baseline to Week 24 in Body Weight | 0.559 kilograms (kg) | Standard Error 0.1949 |
p-value: 0.016695% CI: [0.122, 1.211]ANCOVA
Secondary
Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Fasting blood glucose (FBG) and post prandial glucose (PPG) \[pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)\] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
Time frame: Baseline, 24 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Analog Mid Mixture | Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | FBG | -2.105 mmol/L | Standard Error 0.1544 |
| Insulin Analog Mid Mixture | Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | PPG | -4.184 mmol/L | Standard Error 0.2344 |
| Basal Insulin Analog | Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | FBG | -2.374 mmol/L | Standard Error 0.1551 |
| Basal Insulin Analog | Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | PPG | -4.101 mmol/L | Standard Error 0.2367 |
Comparison: FBGp-value: 0.219395% CI: [-0.161, 0.7]ANCOVA
Comparison: PPGp-value: 0.801495% CI: [-0.739, 0.571]ANCOVA
Secondary
Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
Time frame: Baseline, 24 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Analog Mid Mixture | Change From Baseline to Week 24 in Venous Fasting Plasma Glucose | -2.332 millimole/liter (mmol/L) | Standard Error 0.1525 |
| Basal Insulin Analog | Change From Baseline to Week 24 in Venous Fasting Plasma Glucose | -2.755 millimole/liter (mmol/L) | Standard Error 0.1517 |
p-value: 0.049795% CI: [0, 0.846]ANCOVA
Secondary
Change From Baseline to Week 48 in Body Weight
LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
Time frame: Baseline, 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Analog Mid Mixture | Change From Baseline to Week 48 in Body Weight | 1.393 kilograms (kg) | Standard Error 0.2037 |
| Basal Insulin Analog | Change From Baseline to Week 48 in Body Weight | 0.639 kilograms (kg) | Standard Error 0.2012 |
p-value: 0.008695% CI: [0.192, 1.316]ANCOVA
Secondary
Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Fasting blood glucose (FBG) and post prandial glucose (PPG) \[pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)\] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
Time frame: Baseline, 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Analog Mid Mixture | Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | FBG | -2.233 mmol/L | Standard Error 0.1429 |
| Insulin Analog Mid Mixture | Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | PPG | -4.372 mmol/L | Standard Error 0.2129 |
| Basal Insulin Analog | Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | FBG | -2.724 mmol/L | Standard Error 0.1444 |
| Basal Insulin Analog | Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose | PPG | -4.359 mmol/L | Standard Error 0.2153 |
Comparison: FBGp-value: 0.01695% CI: [0.092, 0.891]ANCOVA
Comparison: PPGp-value: 0.966195% CI: [-0.608, 0.582]ANCOVA
Secondary
Change From Baseline to Week 48 in HbA1c
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
Time frame: Baseline, 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Analog Mid Mixture | Change From Baseline to Week 48 in HbA1c | -2.029 Percentage of HbA1c | Standard Error 0.0631 |
| Basal Insulin Analog | Change From Baseline to Week 48 in HbA1c | -1.829 Percentage of HbA1c | Standard Error 0.0627 |
p-value: 0.024695% CI: [-0.376, -0.026]ANCOVA
Secondary
Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.
Time frame: Baseline, 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for SEITQ Score.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Analog Mid Mixture | Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score | -0.9 Units on a scale | Standard Error 0.23 |
| Basal Insulin Analog | Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score | -0.8 Units on a scale | Standard Error 0.24 |
p-value: 0.755395% CI: [-0.8, 0.5]Mixed Models Analysis
Secondary
Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
Time frame: Baseline, 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Analog Mid Mixture | Change From Baseline to Week 48 in Venous Fasting Plasma Glucose | -2.527 millimole/liter (mmol/L) | Standard Error 0.1391 |
| Basal Insulin Analog | Change From Baseline to Week 48 in Venous Fasting Plasma Glucose | -3.174 millimole/liter (mmol/L) | Standard Error 0.1373 |
p-value: 0.00195% CI: [0.263, 1.031]ANCOVA
Secondary
Number of Participants With Insulin Treatment Change at Week 48
Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency. 1. Discontinuation: Defined as stopping insulin treatment for 30 days or more. 2. Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class. 3. Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group 4. Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.
Time frame: Baseline through 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Insulin Treatment Change.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Insulin Analog Mid Mixture | Number of Participants With Insulin Treatment Change at Week 48 | Discontinuation | 23 Participants |
| Insulin Analog Mid Mixture | Number of Participants With Insulin Treatment Change at Week 48 | Switching | 23 Participants |
| Insulin Analog Mid Mixture | Number of Participants With Insulin Treatment Change at Week 48 | Intensification | 15 Participants |
| Insulin Analog Mid Mixture | Number of Participants With Insulin Treatment Change at Week 48 | Reduction | 12 Participants |
| Basal Insulin Analog | Number of Participants With Insulin Treatment Change at Week 48 | Reduction | 0 Participants |
| Basal Insulin Analog | Number of Participants With Insulin Treatment Change at Week 48 | Discontinuation | 31 Participants |
| Basal Insulin Analog | Number of Participants With Insulin Treatment Change at Week 48 | Intensification | 9 Participants |
| Basal Insulin Analog | Number of Participants With Insulin Treatment Change at Week 48 | Switching | 24 Participants |
Secondary
Percentage of Participants Who Achieve HbA1c <7% at Week 24
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time frame: 24 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c \<7%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Analog Mid Mixture | Percentage of Participants Who Achieve HbA1c <7% at Week 24 | 33.9 Percentage of participants |
| Basal Insulin Analog | Percentage of Participants Who Achieve HbA1c <7% at Week 24 | 28.3 Percentage of participants |
p-value: 0.094195% CI: [0.95, 1.87]Regression, Logistic
Secondary
Percentage of Participants Who Achieve HbA1c <7% at Week 48
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time frame: 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c \<7%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Analog Mid Mixture | Percentage of Participants Who Achieve HbA1c <7% at Week 48 | 23.3 Percentage of participants |
| Basal Insulin Analog | Percentage of Participants Who Achieve HbA1c <7% at Week 48 | 23.4 Percentage of participants |
p-value: 0.859295% CI: [0.72, 1.49]Regression, Logistic
Secondary
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of \<7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
Time frame: 24 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c \<7%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Analog Mid Mixture | Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24 | 33.1 Percentage of participants |
| Basal Insulin Analog | Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24 | 29.0 Percentage of participants |
p-value: 0.200995% CI: [0.89, 1.77]Regression, Logistic
Secondary
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of \<7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
Time frame: 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c \<7%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Analog Mid Mixture | Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48 | 23.9 Percentage of participants |
| Basal Insulin Analog | Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48 | 23.7 Percentage of participants |
p-value: 0.805495% CI: [0.72, 1.53]Regression, Logistic
Secondary
Rate of Hypoglycemia at Week 24 and 48
Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.
Time frame: 24 Weeks, 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Hypoglycemia.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Analog Mid Mixture | Rate of Hypoglycemia at Week 24 and 48 | Nocturnal Hypoglycemia (24 Weeks) | 0.54 Events/Participant/Year | Standard Deviation 3.128 |
| Insulin Analog Mid Mixture | Rate of Hypoglycemia at Week 24 and 48 | Nocturnal Hypoglycemia (48 Weeks) | 0.33 Events/Participant/Year | Standard Deviation 1.931 |
| Insulin Analog Mid Mixture | Rate of Hypoglycemia at Week 24 and 48 | Total Hypoglycemia (24 Weeks) | 1.60 Events/Participant/Year | Standard Deviation 5.076 |
| Insulin Analog Mid Mixture | Rate of Hypoglycemia at Week 24 and 48 | Total Hypoglycemia (48 Weeks) | 1.18 Events/Participant/Year | Standard Deviation 3.831 |
| Basal Insulin Analog | Rate of Hypoglycemia at Week 24 and 48 | Total Hypoglycemia (48 Weeks) | 0.45 Events/Participant/Year | Standard Deviation 1.188 |
| Basal Insulin Analog | Rate of Hypoglycemia at Week 24 and 48 | Nocturnal Hypoglycemia (24 Weeks) | 0.24 Events/Participant/Year | Standard Deviation 0.955 |
| Basal Insulin Analog | Rate of Hypoglycemia at Week 24 and 48 | Total Hypoglycemia (24 Weeks) | 0.63 Events/Participant/Year | Standard Deviation 1.785 |
| Basal Insulin Analog | Rate of Hypoglycemia at Week 24 and 48 | Nocturnal Hypoglycemia (48 Weeks) | 0.20 Events/Participant/Year | Standard Deviation 0.753 |
Secondary
Total Daily Insulin Dose at Week 24 and 48
Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
Time frame: 24 Weeks, 48 Weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Daily Insulin Dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Analog Mid Mixture | Total Daily Insulin Dose at Week 24 and 48 | 48 Weeks | 24.22 International Units (IU) per day | Standard Deviation 11.238 |
| Insulin Analog Mid Mixture | Total Daily Insulin Dose at Week 24 and 48 | 24 Weeks | 24.89 International Units (IU) per day | Standard Deviation 10.245 |
| Basal Insulin Analog | Total Daily Insulin Dose at Week 24 and 48 | 24 Weeks | 14.58 International Units (IU) per day | Standard Deviation 7.093 |
| Basal Insulin Analog | Total Daily Insulin Dose at Week 24 and 48 | 48 Weeks | 15.35 International Units (IU) per day | Standard Deviation 7.09 |