Type 2 Diabetes
Conditions
Keywords
Insulin glargine
Brief summary
The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more oral antihyperglycemic medications (OAMs). Participants will continue their OAMs throughout the study.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Have T2DM based on the disease diagnostic criteria World Health Organization (WHO) classification. * Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening. * Have a HbA1c ≥7.0% and ≤11.0%. * Body mass index (BMI) ≤35 kilograms per meter squared.
Exclusion criteria
* Have used insulin therapy (outside of pregnancy) anytime in the past 1 year, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks. * Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days. * Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening. * Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study. * Have had ≥2 emergency room visits or hospitalizations due to poor glucose control. * Have known hypersensitivity or allergy to Lantus® or its excipients. * Are receiving chronic systemic glucocorticoid therapy at pharmacological doses or have received such therapy within 4 weeks immediately preceding screening. * Have obvious signs or symptoms, or laboratory evidence, of liver disease. * Have one of the following concomitant diseases: significant cardiac or gastrointestinal disease. * Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 milligrams per deciliter. * Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia. * Participants with active cancer or personal history of cancer within the previous 5 years. * Are pregnant or intend to become pregnant during the course of the study. * Are women who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®) | Baseline, Week 24 | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment\*visit in the model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | Baseline, Week 24 | Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, 2 Hours After Evening Meal and Bed Time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model. |
| Percentage of Participants With HbA1c <7% at Week 24 | Week 24 | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. |
| Percentage of Participants With HbA1c ≤6.5% at Week 24 | Week 24 | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. |
| Change From Baseline in Glycemic Variability of Fasting Blood Glucose | Baseline, Week 24 | Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning and daily pre-meal blood glucose value from the 7-point self-monitoring blood glucose \[SMBG\] profiles. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model. |
| Basal Insulin Dose Units Per Day | At Week 24 | Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model. |
| Change From Baseline in HbA1c (Lantus® to LY2963016) | Baseline, Week 24 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, treatment, visit and treatment\*visit in the model. |
| Change From Baseline in Body Weight | Baseline, Week 24 | Change from baseline in body weight was evaluated. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model. |
| Insulin Treatment Satisfaction Questionnaire (ITSQ) | At Week 24 | ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen \[(IR) 5 items: domain scores range (DSR) 5-35\], Lifestyle Flexibility \[(LF) 3 items: DSR 3-21\], Glycemic Control \[(GC) 3 items: DSR 3-21\], Hypoglycemic Control \[(HC) 5 items: DSR 5-35\], Insulin Delivery Device \[(IDD) 6 items: DSR 6-42\]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100\*\[(7-mean raw score)/6\]. Higher scores indicate better treatment satisfaction. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model. |
| Number of Participants With Detectable Anti-Glargine Antibodies | Baseline through 24 weeks | Number of participants with detectable anti-glargine antibodies were reported. |
| Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year) | Baseline through 24 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 (participant's treatment duration/365.25) as an offset variable. A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. |
| Change From Baseline in Basal Insulin Dose Units Per Day | Baseline, Week 24 | Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LY2963016 Insulin naive participants started on 10 U LY2963016 given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue OAM. | 359 |
| Lantus® Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM. | 177 |
| Total | 536 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Non-Compliance with Study Drug | 0 | 3 |
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 14 | 8 |
Baseline characteristics
| Characteristic | Lantus® | Total | LY2963016 |
|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 8.9 | 58.7 years STANDARD_DEVIATION 9.4 | 58.3 years STANDARD_DEVIATION 9.6 |
| Baseline Hemoglobin A1c (HbA1c) | 8.39 Percentage of HbA1c STANDARD_DEVIATION 0.92 | 8.41 Percentage of HbA1c STANDARD_DEVIATION 1 | 8.42 Percentage of HbA1c STANDARD_DEVIATION 1.04 |
| Duration of Diabetes | 10.69 years STANDARD_DEVIATION 5.94 | 10.29 years STANDARD_DEVIATION 5.63 | 10.09 years STANDARD_DEVIATION 5.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 177 Participants | 536 Participants | 359 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 | 177 Participants | 536 Participants | 359 Participants |
| Sex: Female, Male Female | 79 Participants | 229 Participants | 150 Participants |
| Sex: Female, Male Male | 98 Participants | 307 Participants | 209 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 359 | 0 / 177 |
| other Total, other adverse events | 194 / 359 | 95 / 177 |
| serious Total, serious adverse events | 28 / 359 | 14 / 177 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment\*visit in the model.
Time frame: Baseline, Week 24
Population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline HbA1c value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2963016 | Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®) | -1.27 Percentage of HbA1c | Standard Error 0.043 |
| Lantus® | Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®) | -1.23 Percentage of HbA1c | Standard Error 0.062 |
p-value: 0.54595% CI: [-0.19, 0.1]Mixed Models Analysis
Secondary
Basal Insulin Dose Units Per Day
Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model.
Time frame: At Week 24
Population: All randomized participants who received at least one dose of study drug and had a baseline and at least one non-missing post-baseline basal Insulin dose value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2963016 | Basal Insulin Dose Units Per Day | 16.0 units per day (U/day) | Standard Error 0.43 |
| Lantus® | Basal Insulin Dose Units Per Day | 15.7 units per day (U/day) | Standard Error 0.61 |
p-value: 0.7595% CI: [-1.2, 1.7]Mixed Models Analysis
Secondary
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, 2 Hours After Evening Meal and Bed Time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model.
Time frame: Baseline, Week 24
Population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline SMBG value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2963016 | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | Before Mid-Day Meal Glucose | -43.2 milligrams per deciliter (mg/dL) | Standard Error 2.03 |
| LY2963016 | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | Before Evening Meal Glucose | -32.1 milligrams per deciliter (mg/dL) | Standard Error 2.21 |
| LY2963016 | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | 2 Hours After Morning Meal Glucose | -56.3 milligrams per deciliter (mg/dL) | Standard Error 2.34 |
| LY2963016 | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | 2 Hours After Evening Meal Glucose | -29.7 milligrams per deciliter (mg/dL) | Standard Error 2.46 |
| LY2963016 | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | 2 Hours After Mid-Day Meal Glucose | -31.0 milligrams per deciliter (mg/dL) | Standard Error 2.31 |
| LY2963016 | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | Bedtime Glucose | -31.6 milligrams per deciliter (mg/dL) | Standard Error 2.35 |
| LY2963016 | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | Before Morning Meal Glucose | -48.7 milligrams per deciliter (mg/dL) | Standard Error 1.09 |
| Lantus® | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | Bedtime Glucose | -33.0 milligrams per deciliter (mg/dL) | Standard Error 3.4 |
| Lantus® | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | Before Morning Meal Glucose | -49.7 milligrams per deciliter (mg/dL) | Standard Error 1.59 |
| Lantus® | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | 2 Hours After Morning Meal Glucose | -52.7 milligrams per deciliter (mg/dL) | Standard Error 3.39 |
| Lantus® | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | Before Mid-Day Meal Glucose | -39.9 milligrams per deciliter (mg/dL) | Standard Error 2.93 |
| Lantus® | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | 2 Hours After Mid-Day Meal Glucose | -35.9 milligrams per deciliter (mg/dL) | Standard Error 3.33 |
| Lantus® | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | Before Evening Meal Glucose | -33.0 milligrams per deciliter (mg/dL) | Standard Error 3.19 |
| Lantus® | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | 2 Hours After Evening Meal Glucose | -32.0 milligrams per deciliter (mg/dL) | Standard Error 3.55 |
Comparison: 2 Hours After Mid-Day Meal Glucosep-value: 0.2395% CI: [-3.1, 12.8]Mixed Models Analysis
Comparison: Before Evening Meal Glucosep-value: 0.81995% CI: [-6.7, 8.5]Mixed Models Analysis
Comparison: 2 Hours After Evening Meal Glucosep-value: 0.58895% CI: [-6.2, 10.9]Mixed Models Analysis
Comparison: Bedtime Glucosep-value: 0.73295% CI: [-6.7, 9.5]Mixed Models Analysis
Comparison: Before Morning Meal Glucosep-value: 0.60295% CI: [-2.8, 4.8]Mixed Models Analysis
Comparison: 2 Hours After Morning Meal Glucosep-value: 0.37395% CI: [-11.8, 4.4]Mixed Models Analysis
Comparison: Before Mid-Day Meal Glucosep-value: 0.35195% CI: [-10.3, 3.7]Mixed Models Analysis
Secondary
Change From Baseline in Basal Insulin Dose Units Per Day
Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model.
Time frame: Baseline, Week 24
Population: All randomized participants who received at least one dose of study drug and had a baseline and at least one non-missing post-baseline basal Insulin dose value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2963016 | Change From Baseline in Basal Insulin Dose Units Per Day | 7.0 U/day | Standard Error 0.43 |
| Lantus® | Change From Baseline in Basal Insulin Dose Units Per Day | 6.8 U/day | Standard Error 0.61 |
p-value: 0.7595% CI: [-1.2, 1.7]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight
Change from baseline in body weight was evaluated. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model.
Time frame: Baseline, Week 24
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and at least one non-missing post-baseline body weight data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2963016 | Change From Baseline in Body Weight | 1.1 kilogram (kg) | Standard Error 0.13 |
| Lantus® | Change From Baseline in Body Weight | 1.2 kilogram (kg) | Standard Error 0.19 |
p-value: <0.00195% CI: [-0.6, 0.3]Mixed Models Analysis
Secondary
Change From Baseline in Glycemic Variability of Fasting Blood Glucose
Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning and daily pre-meal blood glucose value from the 7-point self-monitoring blood glucose \[SMBG\] profiles. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model.
Time frame: Baseline, Week 24
Population: All randomized participants who received at least one dose of study drug and had a baseline and at least one non-missing post-baseline SMBG value.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2963016 | Change From Baseline in Glycemic Variability of Fasting Blood Glucose | Daily Mean Standard Deviation | -4.1 milligrams per deciliter (mg/dL) | Standard Error 0.85 |
| LY2963016 | Change From Baseline in Glycemic Variability of Fasting Blood Glucose | Morning Pre-meal Standard Deviation | -2.17 milligrams per deciliter (mg/dL) | Standard Error 0.606 |
| Lantus® | Change From Baseline in Glycemic Variability of Fasting Blood Glucose | Morning Pre-meal Standard Deviation | -2.49 milligrams per deciliter (mg/dL) | Standard Error 0.879 |
| Lantus® | Change From Baseline in Glycemic Variability of Fasting Blood Glucose | Daily Mean Standard Deviation | -4.5 milligrams per deciliter (mg/dL) | Standard Error 1.22 |
Comparison: Morning Pre-meal Standard Deviationp-value: 0.76795% CI: [-1.78, 2.42]Mixed Models Analysis
Comparison: Daily Mean Standard Deviationp-value: 0.78195% CI: [-2.5, 3.3]Mixed Models Analysis
Secondary
Change From Baseline in HbA1c (Lantus® to LY2963016)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, treatment, visit and treatment\*visit in the model.
Time frame: Baseline, Week 24
Population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline HbA1c value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2963016 | Change From Baseline in HbA1c (Lantus® to LY2963016) | -1.27 Percentage of HbA1c | Standard Error 0.043 |
| Lantus® | Change From Baseline in HbA1c (Lantus® to LY2963016) | -1.23 Percentage of HbA1c | Standard Error 0.062 |
p-value: 0.54595% CI: [-0.19, 0.1]Mixed Models Analysis
Secondary
Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen \[(IR) 5 items: domain scores range (DSR) 5-35\], Lifestyle Flexibility \[(LF) 3 items: DSR 3-21\], Glycemic Control \[(GC) 3 items: DSR 3-21\], Hypoglycemic Control \[(HC) 5 items: DSR 5-35\], Insulin Delivery Device \[(IDD) 6 items: DSR 6-42\]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100\*\[(7-mean raw score)/6\]. Higher scores indicate better treatment satisfaction. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model.
Time frame: At Week 24
Population: All randomized participants who received at least 1 dose of study drug and had evaluable ITSQ data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2963016 | Insulin Treatment Satisfaction Questionnaire (ITSQ) | GC | 87.80 units on a scale | Standard Error 0.84 |
| LY2963016 | Insulin Treatment Satisfaction Questionnaire (ITSQ) | HC | 89.07 units on a scale | Standard Error 0.79 |
| LY2963016 | Insulin Treatment Satisfaction Questionnaire (ITSQ) | IDD | 86.84 units on a scale | Standard Error 0.86 |
| LY2963016 | Insulin Treatment Satisfaction Questionnaire (ITSQ) | ITSQ Overall Total | 87.32 units on a scale | Standard Error 0.75 |
| LY2963016 | Insulin Treatment Satisfaction Questionnaire (ITSQ) | IR | 89.36 units on a scale | Standard Error 0.8 |
| LY2963016 | Insulin Treatment Satisfaction Questionnaire (ITSQ) | LF | 83.70 units on a scale | Standard Error 1.05 |
| Lantus® | Insulin Treatment Satisfaction Questionnaire (ITSQ) | IR | 90.31 units on a scale | Standard Error 1.16 |
| Lantus® | Insulin Treatment Satisfaction Questionnaire (ITSQ) | ITSQ Overall Total | 88.99 units on a scale | Standard Error 1.08 |
| Lantus® | Insulin Treatment Satisfaction Questionnaire (ITSQ) | HC | 90.86 units on a scale | Standard Error 1.15 |
| Lantus® | Insulin Treatment Satisfaction Questionnaire (ITSQ) | GC | 87.83 units on a scale | Standard Error 1.21 |
| Lantus® | Insulin Treatment Satisfaction Questionnaire (ITSQ) | LF | 87.69 units on a scale | Standard Error 1.52 |
| Lantus® | Insulin Treatment Satisfaction Questionnaire (ITSQ) | IDD | 88.29 units on a scale | Standard Error 1.24 |
Comparison: Inconvenience of Regimen Transformed Scorep-value: 0.595% CI: [-3.72, 1.82]Mixed Models Analysis
Comparison: Lifestyle Flexibility Transformed Scorep-value: 0.03195% CI: [-7.62, -0.36]Mixed Models Analysis
Comparison: Hypoglycemic Control Transformed Scorep-value: 0.295% CI: [-4.53, 0.95]Mixed Models Analysis
Comparison: Glycemic Control Transformed Scorep-value: 0.98895% CI: [-2.92, 2.88]Mixed Models Analysis
Comparison: Insulin Delivery Device Satisfaction Transformed Scorep-value: 0.33795% CI: [-4.41, 1.51]Mixed Models Analysis
Comparison: ITSQ Overall Totalp-value: 0.20595% CI: [-4.26, 0.92]Mixed Models Analysis
Secondary
Number of Participants With Detectable Anti-Glargine Antibodies
Number of participants with detectable anti-glargine antibodies were reported.
Time frame: Baseline through 24 weeks
Population: All randomized participants who received at least 1 dose of study drug. Only participants with detected insulin antibody levels at baseline and at least one non-missing post-baseline were included in analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LY2963016 | Number of Participants With Detectable Anti-Glargine Antibodies | 69 participants |
| Lantus® | Number of Participants With Detectable Anti-Glargine Antibodies | 31 participants |
p-value: 0.639Fisher Exact
Secondary
Percentage of Participants With HbA1c ≤6.5% at Week 24
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Time frame: Week 24
Population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline HbA1c value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LY2963016 | Percentage of Participants With HbA1c ≤6.5% at Week 24 | 23.4 Percentage of participants |
| Lantus® | Percentage of Participants With HbA1c ≤6.5% at Week 24 | 16.5 Percentage of participants |
p-value: 0.098Fisher Exact
Secondary
Percentage of Participants With HbA1c <7% at Week 24
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Time frame: Week 24
Population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one non-missing post-baseline HbA1c value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LY2963016 | Percentage of Participants With HbA1c <7% at Week 24 | 43.7 Percentage of participants |
| Lantus® | Percentage of Participants With HbA1c <7% at Week 24 | 44.9 Percentage of participants |
p-value: 0.846Fisher Exact
Secondary
Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year)
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 (participant's treatment duration/365.25) as an offset variable. A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking.
Time frame: Baseline through 24 weeks
Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and at least one non-missing post-baseline hypoglycemic event.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2963016 | Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year) | Total hypoglycemia | 1.37 events/participant/year | Standard Error 0.228 |
| LY2963016 | Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year) | Nocturnal Hypoglycemia | 0.47 events/participant/year | Standard Error 0.132 |
| Lantus® | Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year) | Total hypoglycemia | 1.15 events/participant/year | Standard Error 0.28 |
| Lantus® | Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year) | Nocturnal Hypoglycemia | 0.39 events/participant/year | Standard Error 0.11 |
p-value: 0.14395% CI: [0.74, 1.92]Wilcoxon (Mann-Whitney)
p-value: 0.94595% CI: [0.67, 2.23]Wilcoxon (Mann-Whitney)