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CompletedNCT03338010Updated May 25, 2021Results posted

A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus

A Phase 3 interventional study of LY2963016 and Lantus® in Type 2 Diabetes, sponsored by Eli Lilly and Company. Completed at 32 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-25.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
536
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Insulin glargine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
536 participants (actual)

Study arms

  • Experimental
    LY2963016

    Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the fasting blood glucose (FBG) ≤100 milligram per deciliter (mg/dL) (5.6 millimoles per litre \[mmol/L\]) while avoiding hypoglycemia. Participants were allowed to continue oral antihyperglycemic medication (OAM).

    Drug: LY2963016

  • Active comparator
    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.

    Drug: Lantus®

Interventions

  • DrugLY2963016

    Administered SC

  • DrugLantus®

    Administered SC

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Number of Participants With Detectable Anti-Glargine Antibodies

    Number of participants with detectable anti-glargine antibodies were reported.

    Time frame: Baseline through 24 weeks

  11. 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

06

Results

Posted May 25, 2021

Participant flow

Participant flow — Overall Study
MilestoneLY2963016Lantus®
Started359177
Received at least one dose of study drug359177
Completed336159
Not completed2318
Withdrew: Withdrawal by subject148
Withdrew: Lost to follow-up42
Withdrew: Adverse event32
Withdrew: Physician decision22
Withdrew: Non-compliance with study drug03
Withdrew: Protocol violation01

Outcome measures

PrimaryChange 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
Reported as:
Least squares mean · Percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)
Percentage of HbA1cLY2963016Lantus®
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)-1.27 ± 0.043-1.23 ± 0.062
Statistical analysis
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.545 · Ls mean difference: -0.05 · 95% CI -0.19 to 0.10
SecondaryChange 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
Reported as:
Least squares mean · Percentage of HbA1c
Change From Baseline in HbA1c (Lantus® to LY2963016)
Percentage of HbA1cLY2963016Lantus®
Change From Baseline in HbA1c (Lantus® to LY2963016)-1.27 ± 0.043-1.23 ± 0.062
Statistical analysis
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.545 · Ls mean difference: -0.05 · 95% CI -0.19 to 0.10
SecondaryChange 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
Reported as:
Least squares mean · milligrams per deciliter (mg/dL)
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
milligrams per deciliter (mg/dL)LY2963016Lantus®
Before Morning Meal Glucose-48.7 ± 1.09-49.7 ± 1.59
2 Hours After Morning Meal Glucose-56.3 ± 2.34-52.7 ± 3.39
Before Mid-Day Meal Glucose-43.2 ± 2.03-39.9 ± 2.93
2 Hours After Mid-Day Meal Glucose-31.0 ± 2.31-35.9 ± 3.33
Before Evening Meal Glucose-32.1 ± 2.21-33.0 ± 3.19
2 Hours After Evening Meal Glucose-29.7 ± 2.46-32.0 ± 3.55
Bedtime Glucose-31.6 ± 2.35-33.0 ± 3.40
Statistical analysis
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.602 · Ls mean difference: 1.0 · 95% CI -2.8 to 4.8
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.373 · Ls mean difference: -3.7 · 95% CI -11.8 to 4.4
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.351 · Ls mean difference: -3.3 · 95% CI -10.3 to 3.7
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.230 · Ls mean difference: 4.9 · 95% CI -3.1 to 12.8
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.819 · Ls mean difference: 0.9 · 95% CI -6.7 to 8.5
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.588 · Ls mean difference: 2.3 · 95% CI -6.2 to 10.9
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.732 · Ls mean difference: 1.4 · 95% CI -6.7 to 9.5
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With HbA1c <7% at Week 24
Percentage of participantsLY2963016Lantus®
Percentage of Participants With HbA1c <7% at Week 2443.744.9
Statistical analysis
  • LY2963016 vs Lantus® · Fisher Exact · p = 0.846
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants With HbA1c ≤6.5% at Week 24
Percentage of participantsLY2963016Lantus®
Percentage of Participants With HbA1c ≤6.5% at Week 2423.416.5
Statistical analysis
  • LY2963016 vs Lantus® · Fisher Exact · p = 0.098
SecondaryChange 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
Reported as:
Least squares mean · milligrams per deciliter (mg/dL)
Change From Baseline in Glycemic Variability of Fasting Blood Glucose
milligrams per deciliter (mg/dL)LY2963016Lantus®
Morning Pre-meal Standard Deviation-2.17 ± 0.606-2.49 ± 0.879
Daily Mean Standard Deviation-4.1 ± 0.85-4.5 ± 1.22
Statistical analysis
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.767 · Ls mean difference: 0.32 · 95% CI -1.78 to 2.42
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.781 · Ls mean difference: 0.4 · 95% CI -2.5 to 3.3
SecondaryBasal 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
Reported as:
Least squares mean · units per day (U/day)
Basal Insulin Dose Units Per Day
units per day (U/day)LY2963016Lantus®
Basal Insulin Dose Units Per Day16.0 ± 0.4315.7 ± 0.61
Statistical analysis
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.750 · Ls mean difference: 0.2 · 95% CI -1.2 to 1.7
SecondaryChange 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
Reported as:
Least squares mean · U/day
Change From Baseline in Basal Insulin Dose Units Per Day
U/dayLY2963016Lantus®
Change From Baseline in Basal Insulin Dose Units Per Day7.0 ± 0.436.8 ± 0.61
Statistical analysis
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.750 · Ls mean difference: 0.2 · 95% CI -1.2 to 1.7
SecondaryChange 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
Reported as:
Least squares mean · kilogram (kg)
Change From Baseline in Body Weight
kilogram (kg)LY2963016Lantus®
Change From Baseline in Body Weight1.1 ± 0.131.2 ± 0.19
Statistical analysis
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = <0.001 · Ls mean difference: -0.1 · 95% CI -0.6 to 0.3
SecondaryInsulin 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
Reported as:
Least squares mean · units on a scale
Insulin Treatment Satisfaction Questionnaire (ITSQ)
units on a scaleLY2963016Lantus®
IR89.36 ± 0.8090.31 ± 1.16
LF83.70 ± 1.0587.69 ± 1.52
HC89.07 ± 0.7990.86 ± 1.15
GC87.80 ± 0.8487.83 ± 1.21
IDD86.84 ± 0.8688.29 ± 1.24
ITSQ Overall Total87.32 ± 0.7588.99 ± 1.08
Statistical analysis
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.500 · Ls mean difference: -0.95 · 95% CI -3.72 to 1.82
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.031 · Ls mean difference: -3.99 · 95% CI -7.62 to -0.36
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.200 · Ls mean difference: -1.79 · 95% CI -4.53 to 0.95
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.988 · Ls mean difference: -0.02 · 95% CI -2.92 to 2.88
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.337 · Ls mean difference: -1.45 · 95% CI -4.41 to 1.51
  • LY2963016 vs Lantus® · Mixed Models Analysis · p = 0.205 · Ls mean difference: -1.67 · 95% CI -4.26 to 0.92
SecondaryNumber of Participants With Detectable Anti-Glargine Antibodies

Number of participants with detectable anti-glargine antibodies were reported.

Time frame:
Baseline through 24 weeks
Reported as:
Number · participants
Number of Participants With Detectable Anti-Glargine Antibodies
participantsLY2963016Lantus®
Number of Participants With Detectable Anti-Glargine Antibodies6931
Statistical analysis
  • LY2963016 vs Lantus® · Fisher Exact · p = 0.639
SecondaryRate 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
Reported as:
Least squares mean · events/participant/year
Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year)
events/participant/yearLY2963016Lantus®
Total hypoglycemia1.37 ± 0.2281.15 ± 0.280
Nocturnal Hypoglycemia0.47 ± 0.1320.39 ± 0.110
Statistical analysis
  • LY2963016 vs Lantus® · Wilcoxon (Mann-Whitney) · p = 0.143 · Relative ratio: 1.19 · 95% CI 0.74 to 1.92
  • LY2963016 vs Lantus® · Wilcoxon (Mann-Whitney) · p = 0.945 · Relative ratio: 1.22 · 95% CI 0.67 to 2.23

Adverse events

Collected over Baseline Up To 28 Weeks. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LY29630160/359 (0%)28/359 (7.8%)194/359 (54%)
Lantus®0/177 (0%)14/177 (7.9%)95/177 (53.7%)
Most frequent serious events
Showing 10 of 42
Most frequent serious events
EventLY2963016Lantus®
Cerebral infarctionNervous system disorders5/3592/177
PneumoniaInfections and infestations3/3591/177
AnaemiaBlood and lymphatic system disorders0/3591/177
Cardiac failure congestiveCardiac disorders0/3591/177
Coronary artery diseaseCardiac disorders1/3591/177
ColitisGastrointestinal disorders0/3591/177
Gastrointestinal polypGastrointestinal disorders0/3591/177
Large intestine polypGastrointestinal disorders1/3591/177
Hepatitis eInfections and infestations0/3591/177
Soft tissue infectionInfections and infestations1/3591/177
Most frequent other events
Showing 10 of 73
Most frequent other events
EventLY2963016Lantus®
Upper respiratory tract infectionInfections and infestations73/35932/177
Weight increasedInvestigations14/35911/177
HypertensionVascular disorders20/3597/177
Injection site painGeneral disorders15/3595/177
NasopharyngitisInfections and infestations8/3597/177
CoughRespiratory, thoracic and mediastinal disorders13/3595/177
BronchitisInfections and infestations3/3596/177
Diabetic neuropathyNervous system disorders1/3595/177
DiarrhoeaGastrointestinal disorders10/3594/177
ToothacheGastrointestinal disorders9/3591/177

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)LY2963016Lantus®Total
Mean58.3 ± 9.659.5 ± 8.958.7 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)LY2963016Lantus®Total
Female15079229
Male20998307
Race (NIH/OMB)
Race (NIH/OMB)(Participants)LY2963016Lantus®Total
American Indian or Alaska Native000
Asian359177536
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)LY2963016Lantus®Total
China359177536
Baseline Hemoglobin A1c (HbA1c)
Baseline Hemoglobin A1c (HbA1c)(Percentage of HbA1c)LY2963016Lantus®Total
Mean8.42 ± 1.048.39 ± 0.928.41 ± 1.00
Duration of Diabetes
Duration of Diabetes(years)LY2963016Lantus®Total
Mean10.09 ± 5.4710.69 ± 5.9410.29 ± 5.63
07

Study locations

32 sites
  • Anhui Provincial Hospital
    Hefei, Anhui 230001, China
  • The First Affiliated Hospital of Lanzhou University
    Lanzhou, Gansu 730000, China
  • Shantou University Medical College No.2 Affiliated Hospital
    Shantou, Guang Dong Province 515041, China
  • Guangdong Province People's Hospital
    Guangzhou, Guangdong 510080, China
  • The First Affiliated Hospital, Sun-Yat Sen University
    Guangzhou, Guangdong 510080, China
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    Guangzhou, Guangdong 510120, China
  • The 1st Affiliated Hospital of Henan Science and technology
    Luoyang, Henan 471003, China
  • Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
    Wu Han, Hubei 430030, China
  • Wuhan Central Hospital
    Wuhan, Hubei 430014, China
  • The First People Hospital of Yueyang
    Yueyang, Hunan 414000, China
  • Changzhou No.2 People's Hospital
    Changzhou, Jiangsu 213003, China
  • The Affliated Jiangyin Hospital of Southeast University Medical College
    Jiangyin, Jiangsu 214400, China
  • Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
    Nanjing, Jiangsu 210008, China
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210011, China
  • Nanjing First Hospital
    Nanjing, Jiangsu 210012, China
  • Nanjing Jiangning Hospital
    Nanjing, Jiangsu 211199, China
  • Wuxi People's Hospital
    Wuxi, Jiangsu 214023, China
  • Xuzhou central Hospital
    Xuzhou, Jiangsu 221009, China
  • Affiliated Hospital of Jiangsu University
    Zhenjiang, Jiangsu 212001, China
  • No.2 Hospital Affiliated to Jilin University
    Changchun City, Jilin 130041, China
  • Siping central people's hospital
    Siping, Jilin 136000, China
  • Dalian Med. Univ. No 2 Affiliate Hospital
    Dalian, Liao Ning 116023, China
  • Shengjing Hospital of China Medical University
    Shenyang, Liaoning 110022, China
  • The First Affiliated Hospital with Nanjing Medical Universit
    Nanjing, Nanjing 210029, China
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia 750004, China
  • 1st affiliated Hospital of Shanxi Medical University
    Tai Yuan, Shan XI 030001, China
  • Jinan Central Hospital
    Jinan, Shandong 250013, China
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
  • Peking Union Medical College Hospital
    Beijing, 88798, China
  • Chongqing General Hospital
    Chongqing, 400013, China
  • Shanghai Putuo District Center Hospital
    Shanghai, 200062, China
  • Tianjin Medical University General Hospital
    Tianjin, 300052, China
08

References and documents

Study documents

  • Study protocol · Mar 2, 2017
  • Statistical analysis plan · May 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

09

Registry details

Key details

Study ID
NCT03338010
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 9, 2017
Start date
Mar 22, 2018
Primary completion
Mar 18, 2020
Completion
Mar 18, 2020
Results posted
May 25, 2021
Last update
May 25, 2021

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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