Trial Outcomes & Findings for A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus (NCT NCT03338023)

Last Updated: 2021-03-29

Results Overview

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated using mixed-effects model for repeated measures (MMRM) with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time\*Treatment (Type III sum of squares).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

272 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2021-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	LY2963016 + Insulin Lispro Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Overall Study STARTED	137	135
Overall Study Received at Least One Dose of Study Drug	137	135
Overall Study COMPLETED	128	125
Overall Study NOT COMPLETED	9	10

Reasons for withdrawal

Reasons for withdrawal
Measure	LY2963016 + Insulin Lispro Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Overall Study Withdrawal by Subject	3	4
Overall Study Protocol Violation	3	3
Overall Study Lost to Follow-up	2	1
Overall Study Physician Decision	1	2

Baseline Characteristics

A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LY2963016 + Insulin Lispro n=137 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=135 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Total n=272 Participants Total of all reporting groups
Age, Continuous	41.8 years STANDARD_DEVIATION 15.0 • n=5 Participants	41.4 years STANDARD_DEVIATION 13.8 • n=7 Participants	41.6 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	66 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	69 Participants n=7 Participants	129 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	137 Participants n=5 Participants	135 Participants n=7 Participants	272 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	137 Participants n=5 Participants	135 Participants n=7 Participants	272 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 China	137 Participants n=5 Participants	135 Participants n=7 Participants	272 Participants n=5 Participants
Hemoglobin A1c (HbA1c) at Baseline	7.90 Percentage of HbA1c STANDARD_DEVIATION 1.32 • n=5 Participants	7.85 Percentage of HbA1c STANDARD_DEVIATION 1.48 • n=7 Participants	7.88 Percentage of HbA1c STANDARD_DEVIATION 1.40 • n=5 Participants
Duration of Diabetes in years	10.29 years STANDARD_DEVIATION 9.53 • n=5 Participants	10.53 years STANDARD_DEVIATION 9.53 • n=7 Participants	10.41 years STANDARD_DEVIATION 9.51 • n=5 Participants
Body Mass Index (BMI)	21.90 kilogram per meter square (kg/m²) STANDARD_DEVIATION 2.54 • n=5 Participants	22.03 kilogram per meter square (kg/m²) STANDARD_DEVIATION 2.32 • n=7 Participants	21.96 kilogram per meter square (kg/m²) STANDARD_DEVIATION 2.43 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline HbA1c value.

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=127 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=125 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®)	-0.20 Percentage of HbA1c Standard Error 0.071	-0.08 Percentage of HbA1c Standard Error 0.071

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline HbA1c value.

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 using MMRM with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time\*Treatment (Type III sum of squares).

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=127 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=125 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Change From Baseline in HbA1c (Lantus® Noninferior to LY2963016)	-0.20 Percentage of HbA1c Standard Error 0.071	-0.08 Percentage of HbA1c Standard Error 0.071

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline SMBG value.

The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Before Morning Meal Glucose, 2 Hours After Morning Meal Glucose, Before Mid-Day Meal Glucose, 2 Hours After Mid-Day Meal Glucose, Before Evening Meal Glucose, Bedtime Glucose and 0300 Am Glucose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=127 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=124 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values Before Morning Meal Glucose	-7.2 milligrams per deciliter (mg/dL) Standard Error 3.64	-0.4 milligrams per deciliter (mg/dL) Standard Error 3.68
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values 2 Hours After Morning Meal Glucose	-10.6 milligrams per deciliter (mg/dL) Standard Error 4.77	-2.8 milligrams per deciliter (mg/dL) Standard Error 4.83
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values Before Mid-Day Meal Glucose	-4.6 milligrams per deciliter (mg/dL) Standard Error 4.13	8.5 milligrams per deciliter (mg/dL) Standard Error 4.21
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values 2 Hours After Mid-Day Meal Glucose	-1.6 milligrams per deciliter (mg/dL) Standard Error 4.76	1.9 milligrams per deciliter (mg/dL) Standard Error 4.76
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values Before Evening Meal Glucose	-6.2 milligrams per deciliter (mg/dL) Standard Error 4.78	4.8 milligrams per deciliter (mg/dL) Standard Error 4.85
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values Bedtime Glucose	-0.4 milligrams per deciliter (mg/dL) Standard Error 4.99	5.0 milligrams per deciliter (mg/dL) Standard Error 5.06
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values 0300 Am Glucose	-4.9 milligrams per deciliter (mg/dL) Standard Error 3.87	2.5 milligrams per deciliter (mg/dL) Standard Error 3.94

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants who received at least one dose of study drug and had baseline and postbaseline HbA1c value.

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=127 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=125 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Percentage of Participants With HbA1c <7%	30.7 percentage of participants	32.8 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants who received at least one dose of study drug and had baseline and postbaseline HbA1c value.

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=127 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=125 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Percentage of Participants With HbA1c ≤6.5%	15.7 percentage of participants	22.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline SMBG value.

Change From Baseline in Intrapatient blood glucose (BG). LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=122 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=119 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG	-2.9 mg/dL Standard Error 1.33	-2.6 mg/dL Standard Error 1.34

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline SMBG value.

Change From Baseline in Glycemic Variability of Fasting Blood Glucose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=122 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=119 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Change From Baseline in Glycemic Variability of Fasting Blood Glucose Morning Pre-meal Standard Deviation	-9.0 mg/dL Standard Error 2.53	-5.5 mg/dL Standard Error 2.56
Change From Baseline in Glycemic Variability of Fasting Blood Glucose Daily Mean Standard Deviation	-10.4 mg/dL Standard Error 1.69	-8.6 mg/dL Standard Error 1.71

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline Basal Insulin dose value.

Change from baseline in basal insulin dose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=129 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=127 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Change From Baseline in Basal Insulin Dose	0.7 Units per Day (U/day) Standard Error 0.33	1.5 Units per Day (U/day) Standard Error 0.33

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline Prandial Insulin dose value.

Prandial Insulin Dose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=129 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=127 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Change From Baseline in Prandial Insulin Dose	0.2 U/day Standard Error 0.49	1.4 U/day Standard Error 0.50

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline weight value.

Change from baseline in body weight. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=128 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=125 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Change From Baseline in Body Weight	0.8 kilograms (kg) Standard Error 0.21	0.9 kilograms (kg) Standard Error 0.22

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline ITSQ score.

The ITSQ is a validated 22-item questionnaire that was used to assess treatment satisfaction. Items were measured on a 7-point scale, with lower scores reflecting better outcomes. In addition to an overall score, scores were also obtained for 5 domains, including inconvenience of regimen, lifestyle flexibility, glycemic control, hypoglycemic control, and insulin delivery device. Raw domain and overall scores were transformed on a scale from 0 to 100, where a higher score indicated better treatment satisfaction. LS mean was calculated using ANCOVA with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment (Type III sum of squares).

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=130 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=131 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) ITSQ Inconvenience of Regimen Transformed Score	3.5 score on a scale Standard Error 1.30	3.8 score on a scale Standard Error 1.29
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) ITSQ Lifestyle Flexibility Transformed Score	1.3 score on a scale Standard Error 1.86	2.0 score on a scale Standard Error 1.86
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) ITSQ Hypoglycemic Control Transformed Score	3.2 score on a scale Standard Error 1.39	3.8 score on a scale Standard Error 1.38
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) ITSQ Glycemic Control Transformed Score	6.9 score on a scale Standard Error 1.64	6.0 score on a scale Standard Error 1.64
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) ITSQ Insulin Delivery Device Satisfaction Transformed Score	3.3 score on a scale Standard Error 1.26	2.9 score on a scale Standard Error 1.26
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) ITSQ Total Transformed Score	3.3 score on a scale Standard Error 1.10	4.1 score on a scale Standard Error 1.10

SECONDARY outcome

Timeframe: Baseline through Week 24

Population: All participants who received at least one dose of study drug.Only participants with detected or non-detected insulin antibody levels at baseline and post-baseline were included in analysis.

Number of participants with detectable anti-glargine antibodies

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=136 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=134 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Number of Participants With Detectable Anti-Glargine Antibodies Detectable Anti-Glargine Antibodies	76 Participants	68 Participants
Number of Participants With Detectable Anti-Glargine Antibodies Detectable Cross Reactive Insulin Antibodies	67 Participants	58 Participants
Number of Participants With Detectable Anti-Glargine Antibodies Treatment Emergent Antibody Response (TEAR)	42 Participants	35 Participants

SECONDARY outcome

Timeframe: Baseline through Week 24

Population: All randomized participants who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	LY2963016 + Insulin Lispro n=137 Participants Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=135 Participants Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Rate of Documented Symptomatic Hypoglycemia	12.6 events/participant/year Standard Error 2.42	14.0 events/participant/year Standard Error 2.64

Adverse Events

LY2963016 + Insulin Lispro

Serious events: 9 serious events

Other events: 84 other events

Deaths: 0 deaths

Lantus® + Insulin Lispro

Serious events: 8 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	LY2963016 + Insulin Lispro n=137 participants at risk Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.	Lantus® + Insulin Lispro n=135 participants at risk Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
Cardiac disorders Coronary artery disease	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/135 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Diabetic retinopathy	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/135 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diabetic gastroenteropathy	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/135 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/135 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/135 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/137 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.5% 2/135 • Number of events 2 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pulmonary tuberculosis	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/135 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tonsillitis	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/135 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/137 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/137 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	1.5% 2/137 • Number of events 2 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 3/135 • Number of events 4 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Diabetic neuropathy	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/135 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hypoglycaemic coma	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/135 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Nephritis	0.00% 0/137 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Perinephritis	0.00% 0/137 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Ureterolithiasis	0.73% 1/137 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Ovarian disorder	1.3% 1/77 • Number of events 1 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/66 • Baseline Up To 28 Weeks All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.