Trial Outcomes & Findings for A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment (NCT NCT01894568)
NCT ID: NCT01894568
Last Updated: 2019-03-15
Results Overview
Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein \[LDL-C\], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.
COMPLETED
PHASE3
388 participants
Baseline, Week 26
2019-03-15
Participant Flow
Participant milestones
| Measure |
Insulin Peglispro
Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks.
|
Insulin Glargine
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
196
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
192
|
196
|
|
Overall Study
COMPLETED
|
182
|
186
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Insulin Peglispro
Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks.
|
Insulin Glargine
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Protocol required discontinuation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment
Baseline characteristics by cohort
| Measure |
Insulin Peglispro
n=192 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=196 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
Total
n=388 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
141 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
192 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
388 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
103 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Baseline Hemoglobin A1c (HbA1c)
|
8.59 percent of HbA1c
STANDARD_DEVIATION 1.09 • n=5 Participants
|
8.48 percent of HbA1c
STANDARD_DEVIATION 0.85 • n=7 Participants
|
8.53 percent of HbA1c
STANDARD_DEVIATION 0.97 • n=5 Participants
|
|
Fasting Serum Glucose (FSG)
|
165.11 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 41.25 • n=5 Participants
|
166.64 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 36.81 • n=7 Participants
|
165.88 milligram per deciliter (mg/dL)
STANDARD_DEVIATION 39.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data
Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein \[LDL-C\], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.
Outcome measures
| Measure |
Insulin Peglispro
n=179 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=184 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)
|
-1.61 percent of HbA1c
Standard Error 0.06
|
-1.36 percent of HbA1c
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable HE data.
Hypoglycemia Events (HE) occurs when blood glucose level ≤ 70 milligram per deciliter (mg/dL) (\<3.9 micromoles per liter \[mmol/L\]). Nocturnal HE includes any total HE that occurred between bedtime and waking. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline total hypoglycemia event rate, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Outcome measures
| Measure |
Insulin Peglispro
n=192 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=196 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Total HE
|
1.28 Number of events per participant per 30d
Standard Error 0.23
|
1.21 Number of events per participant per 30d
Standard Error 0.23
|
|
30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Nocturnal HE
|
0.19 Number of events per participant per 30d
Standard Error 0.12
|
0.27 Number of events per participant per 30d
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Weeks 0 and 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable FSG data.
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and sulfonylurea \[SU\]/meglitinide use), visit, and treatment-by-visit interaction.
Outcome measures
| Measure |
Insulin Peglispro
n=191 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=194 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Fasting Serum Glucose (FSG)
Week 0
|
164.31 mg/dL
Standard Error 2.78
|
166.61 mg/dL
Standard Error 2.76
|
|
Fasting Serum Glucose (FSG)
Week 26
|
103.85 mg/dL
Standard Error 1.93
|
110.32 mg/dL
Standard Error 1.90
|
SECONDARY outcome
Timeframe: Weeks 0 and 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable FBG data.
LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.
Outcome measures
| Measure |
Insulin Peglispro
n=190 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=195 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Fasting Blood Glucose (FBG)
Week 0
|
159.53 mg/dL
Standard Error 2.51
|
161.19 mg/dL
Standard Error 2.48
|
|
Fasting Blood Glucose (FBG)
Week 26
|
108.39 mg/dL
Standard Error 1.58
|
108.22 mg/dL
Standard Error 1.55
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable body weight data.
LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.
Outcome measures
| Measure |
Insulin Peglispro
n=190 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=193 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline to Week 26 in Body Weight
|
1.06 Kilogram (kg)
Standard Error 0.16
|
1.57 Kilogram (kg)
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week 0 and Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable SMBG data.
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. The 9-point SMBG are measured at: Pre-morning meal, 2 hours(hr) post morning meal, pre-midday meal, 2 hr post midday meal, pre-evening meal, 2 hr post pre-evening meal, bedtime, 0300 hr, and pre-morning meal next day, and should be performed on 2 non-consecutive days.
Outcome measures
| Measure |
Insulin Peglispro
n=188 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=192 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Morning Pre-meal Wk0
|
160.19 mg/dL
Standard Error 2.65
|
162.83 mg/dL
Standard Error 2.62
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Morning Pre-meal Wk26
|
108.24 mg/dL
Standard Error 1.68
|
108.71 mg/dL
Standard Error 1.65
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Morning Post-meal Wk0
|
237.19 mg/dL
Standard Error 4.26
|
233.37 mg/dL
Standard Error 4.21
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Morning Post-meal Wk26
|
176.97 mg/dL
Standard Error 3.31
|
176.93 mg/dL
Standard Error 3.23
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Mid-day Pre-meal Wk0
|
169.24 mg/dL
Standard Error 3.80
|
166.68 mg/dL
Standard Error 3.76
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Mid-day Pre-meal Wk26
|
122.01 mg/dL
Standard Error 2.56
|
122.85 mg/dL
Standard Error 2.50
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Mid-day Post-meal Wk0
|
224.22 mg/dL
Standard Error 4.23
|
226.11 mg/dL
Standard Error 4.21
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Mid-day Post-meal Wk26
|
182.32 mg/dL
Standard Error 3.26
|
183.88 mg/dL
Standard Error 3.18
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Evening Pre-meal Wk0
|
176.49 mg/dL
Standard Error 3.80
|
172.83 mg/dL
Standard Error 3.75
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Evening Pre-meal Wk26
|
131.65 mg/dL
Standard Error 3.08
|
135.55 mg/dL
Standard Error 2.99
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Evening Post-meal Wk0
|
219.45 mg/dL
Standard Error 4.20
|
219.54 mg/dL
Standard Error 4.16
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Evening Post-meal Wk26
|
176.23 mg/dL
Standard Error 3.37
|
182.80 mg/dL
Standard Error 3.26
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Bed Time Wk0
|
198.64 mg/dL
Standard Error 3.90
|
197.68 mg/dL
Standard Error 3.83
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Bed Time Wk26
|
153.41 mg/dL
Standard Error 2.95
|
161.44 mg/dL
Standard Error 2.87
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
0300 Hours (Hrs) Wk0
|
158.82 mg/dL
Standard Error 3.23
|
162.13 mg/dL
Standard Error 3.20
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
0300 Hrs Wk26
|
115.18 mg/dL
Standard Error 2.34
|
114.77 mg/dL
Standard Error 2.27
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Pre-morning Meal Next Day Wk0
|
156.28 mg/dL
Standard Error 2.57
|
159.96 mg/dL
Standard Error 2.55
|
|
9-Point Self-Monitored Blood Glucose (SMBG)
Pre-morning Meal Next Day Wk26
|
108.42 mg/dL
Standard Error 1.73
|
105.18 mg/dL
Standard Error 1.71
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data.
Percentage of participants with HbA1c ≤6.5% at Week 26 were made using a logistic regression model for endpoint used last observation carried forward (LOCF) method including treatment, baseline HbA1c value.
Outcome measures
| Measure |
Insulin Peglispro
n=191 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=194 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Percentage of Participants With HbA1c ≤6.5%
|
29.8 Percentage of participants
|
22.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable insulin dose and body weight data.
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide), visit, and treatment-by-visit interaction.
Outcome measures
| Measure |
Insulin Peglispro
n=191 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=195 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Insulin Dose Per Kilogram (kg) of Body Weight
|
0.26 units per kg
Standard Error 0.01
|
0.26 units per kg
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable insulin dose data.
Outcome measures
| Measure |
Insulin Peglispro
n=192 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=196 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose])
|
96.9 percentage of participants
|
97.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable laboratory data.
LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit, and treatment-by-visit interaction.
Outcome measures
| Measure |
Insulin Peglispro
n=192 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=196 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26
Cholesterol Wk26
|
175.76 mg/dL
Standard Error 1.65
|
177.90 mg/dL
Standard Error 1.63
|
|
Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26
HDL Wk26
|
51.64 mg/dL
Standard Error 0.49
|
52.99 mg/dL
Standard Error 0.48
|
|
Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26
Triglycerides Wk26
|
132.43 mg/dL
Standard Error 4.71
|
122.83 mg/dL
Standard Error 4.65
|
|
Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26
LDL Wk26
|
97.95 mg/dL
Standard Error 1.48
|
101.07 mg/dL
Standard Error 1.46
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable antibody data.
For participants with detectable anti-insulin peglispro antibody level, the percentage of participants with positive cross-react with endogenous insulin was summarized.
Outcome measures
| Measure |
Insulin Peglispro
n=192 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=196 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26
|
24.6 percentage of participants
|
32.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable EQ-5D data. Missing endpoints were imputed with last observation carried forward (LOCF).
The EuroQoL-5D-3L questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. Overall health state score was self-reported using a VAS marked on a scale of 0 to 100 (0 indicates worst imaginable health state and 100 indicates best imaginable health state. LS means were calculated using analysis of covariance (ANCOVA) for actual measures and changes from baseline at endpoint using LOCF method: adjusting for treatment, stratification factors (region, HbA1c and SU/meglitin.
Outcome measures
| Measure |
Insulin Peglispro
n=184 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=192 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26
Change from Baseline to Endpoint EQ-5D-3L Score
|
0.01 units on a scale
Standard Error 0.01
|
0.00 units on a scale
Standard Error 0.01
|
|
Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26
Change from Baseline VAS Health State Score
|
2.29 units on a scale
Standard Error 0.92
|
3.66 units on a scale
Standard Error 0.90
|
SECONDARY outcome
Timeframe: Week 4 and 26Population: All participants who were randomized and received at least 1 dose of study drug and have evaluable ITSQ data. Missing endpoints were imputed using last observation carried forward (LOCF).
The Insulin Treatment Satisfaction Questionnaire is a validated instrument containing 22 items that assessed treatment satisfaction for participants with diabetes on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means was achieved using a MMRM model for post-baseline measures with stratification factors (country, HbA1c, and SU/meglitinide use) treatment, visit, treatment-by-visit as fixed effects. ITSQ was assessed at Week 4 (baseline) and Week 26.
Outcome measures
| Measure |
Insulin Peglispro
n=188 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=192 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
ITSQ Wk4
|
74.13 units on a scale
Standard Error 1.04
|
75.94 units on a scale
Standard Error 1.03
|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
ITSQ Wk26
|
78.73 units on a scale
Standard Error 1.06
|
78.29 units on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable LBSS data.
LBSS is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 5 - always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range 0 to 132). Higher total scores reflect greater fear of hypoglycemia. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. LBSS was assessed during screening visit (baseline) and again at Week 26.
Outcome measures
| Measure |
Insulin Peglispro
n=184 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=192 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
|
1.51 units on a scale
Standard Error 0.69
|
1.62 units on a scale
Standard Error 0.68
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who were randomized and had at least 1 dose of study drug and had evaluable FBG data.
Intra-participant variability of Fasting Blood Glucose (FBG), which was measured by Self Monitored Blood Glucose (SMBG), was assessed by the standard deviation of the FBG measurement at the Week 26 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Outcome measures
| Measure |
Insulin Peglispro
n=179 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=185 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Intra-Participant Variability of the Fasting Blood Glucose (FBG)
|
14.97 mg/dL
Standard Error 0.76
|
15.12 mg/dL
Standard Error 0.75
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data.
Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months.LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Outcome measures
| Measure |
Insulin Peglispro
n=191 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=194 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c)
|
-1.43 percent of HbA1c
Standard Error 0.05
|
-1.22 percent of HbA1c
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data.
HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Outcome measures
| Measure |
Insulin Peglispro
n=191 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=194 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Percent Hemoglobin A1c at Week 26
|
6.92 percent of HbA1c
Standard Error 0.06
|
7.17 percent of HbA1c
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: All participants who were randomized and received at least 1 dose of study drug and had evaluable HE data.
Percentage of participants with hypoglycemic events (total or nocturnal) to Week 26 based on BG Threshold 70mg/dL.
Outcome measures
| Measure |
Insulin Peglispro
n=192 Participants
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=196 Participants
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)
Nocturnal Hypoglycemia BG 70mg/dL
|
26.6 percentage of participants
|
29.6 percentage of participants
|
|
Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)
Total Hypoglycemia BG 70mg/dL
|
77.1 percentage of participants
|
76.5 percentage of participants
|
Adverse Events
Insulin Peglispro
Insulin Glargine
Serious adverse events
| Measure |
Insulin Peglispro
n=192 participants at risk
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=196 participants at risk
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/192
|
0.51%
1/196 • Number of events 1
|
|
Eye disorders
Glaucoma
|
1.0%
2/192 • Number of events 2
|
0.00%
0/196
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Infections and infestations
Diverticulitis
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Infections and infestations
Pneumonia
|
0.00%
0/192
|
0.51%
1/196 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/192
|
0.51%
1/196 • Number of events 1
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/192
|
1.0%
2/196 • Number of events 2
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/192
|
0.51%
1/196 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Surgical and medical procedures
Fracture treatment
|
0.00%
0/192
|
0.51%
1/196 • Number of events 1
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
|
Surgical and medical procedures
Suprapubic prostatectomy
|
0.52%
1/192 • Number of events 1
|
0.00%
0/196
|
Other adverse events
| Measure |
Insulin Peglispro
n=192 participants at risk
Insulin Peglispro administered SC once daily for 26 weeks.
|
Insulin Glargine
n=196 participants at risk
Insulin Glargine administered SC once daily for 26 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.1%
4/192 • Number of events 4
|
0.51%
1/196 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.1%
6/192 • Number of events 7
|
0.51%
1/196 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
2.1%
4/192 • Number of events 4
|
2.0%
4/196 • Number of events 5
|
|
Infections and infestations
Gastroenteritis
|
2.1%
4/192 • Number of events 5
|
0.51%
1/196 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
18.2%
35/192 • Number of events 46
|
14.8%
29/196 • Number of events 40
|
|
Infections and infestations
Pharyngitis
|
4.2%
8/192 • Number of events 8
|
1.5%
3/196 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
5/192 • Number of events 7
|
0.51%
1/196 • Number of events 1
|
|
Investigations
Weight increased
|
3.1%
6/192 • Number of events 6
|
3.1%
6/196 • Number of events 6
|
|
Nervous system disorders
Headache
|
3.1%
6/192 • Number of events 7
|
1.0%
2/196 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place