Type 1 DiabetesPhase 3NCT03338023
A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus
A Phase 3 study testing LY2963016, Lantus® and Insulin Lispro in people with Type 1 Diabetes, run by Eli Lilly and Company at 20 sites in China.
Trial summary
The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- LY2963016, Lantus® and Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 20 sitesChina
- Study dates
- 23 Mar 2018to 5 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have T1DM based on the disease diagnostic criteria (World Health Organization [WHO] Classification).
- Have duration of T1DM ≥1 year.
- Have HbA1c ≤11 %.
- Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening.
- Have a body mass index (BMI) ≤35 kilograms per meter squared.
Who cannot join
- Exposure to an insulin glargine other than Lantus® within previous 30 days.
- Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study.
- Have known hypersensitivity or allergy to any of the study insulins (Lantus® or insulin lispro) or to excipients of the study insulins.
- Are pregnant, intend to become pregnant during the course of the study.
- Women who are breastfeeding.
Show all 14Show fewer
- Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
- Have congestive heart failure Class III and IV.
- Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease.
- Have any active cancer.
- Have a history or diagnosis of human immunodeficiency virus (HIV) infection.
- Have presence of clinically significant gastrointestinal disease.
- Have a history of renal transplantation, or are currently receiving renal dialysis.
- Are receiving chronic systemic glucocorticoid therapy at pharmacological doses.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044
Peking Union Medical College Hospital
Beijing, 88798
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, 130041
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Dalian Med. Univ. No 2 Affiliate Hospital
Dalian, Liaoning, 116023
Guangdong Province People's Hospital
Guangzhou, Guangdong, 510080
The First Affiliated Hospital, Sun-Yat Sen University
Guangzhou, Guangdong, 510080
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034
The 1st Affiliated Hospital of Henan Science and technology
Luoyang, Henan, 471003
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Nanjing First Hospital
Nanjing, Jiangsu, 210012
The First Affiliated Hospital with Nanjing Medical Universit
Nanjing, Nanjing, 210029
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Shanghai Putuo District Center Hospital
Shanghai, 200062
Shantou University Medical College No.2 Affiliated Hospital
Shantou, Guangdong, 515041
Wu Han Tongji Hospital
Wuhan, Hubei, 430030
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001
About this study
Official title: A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog, LY2963016, to Lantus® in Combination With Mealtime Insulin Lispro in Adult Chinese Patients With Type 1 Diabetes Mellitus
The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM).
- Conditions
- Type 1 Diabetes
- Being tested
- LY2963016, Lantus®, Insulin Lispro
- Keywords
- Insulin Glargine
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2963016Drug
Administered SC
Lantus®Drug
Administered SC
Insulin LisproDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY2963016 + Insulin Lispro | Experimental | 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. Receives: Drug: LY2963016; Drug: Insulin Lispro |
| Lantus® + Insulin Lispro | Active comparator | 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. Receives: Drug: Lantus®; Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®)
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).
Measured: Baseline, Week 24
Secondary outcomes (12)
Change From Baseline in HbA1c (Lantus® Noninferior 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 using MMRM with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time*Treatment (Type III sum of squares).
Measured: Baseline, Week 24
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
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).
Measured: Baseline, Week 24
Percentage of Participants With HbA1c <7%
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Measured: Week 24
Percentage of Participants With HbA1c ≤6.5%
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Measured: Week 24
Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG
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).
Measured: Baseline, Week 24
Change From Baseline in Glycemic Variability of Fasting Blood Glucose
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).
Measured: Baseline, Week 24
Change From Baseline in Basal Insulin Dose
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.
Measured: Baseline, Week 24
Change From Baseline in Prandial Insulin Dose
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.
Measured: Baseline, Week 24
Change From Baseline in Body Weight
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.
Measured: Baseline, Week 24
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ)
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).
Measured: Baseline, Week 24
Number of Participants With Detectable Anti-Glargine Antibodies
Number of participants with detectable anti-glargine antibodies
Measured: Baseline through Week 24
Rate of Documented Symptomatic Hypoglycemia
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.
Measured: Baseline through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start23 Mar 2018
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338023
- Sponsor's protocol ID
- 16036
- Other IDs
- I4L-GH-ABES
- Status last verified
- 15 Apr 2020
- First submitted
- 7 Nov 2017
- Last updated
- 29 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and asigned data sharing agreement.
Publications
Yan X, Feng C, Lou Y, Zhou Z. Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (Lantus(R)): a Post Hoc Analysis of a Randomized, Open-Label, Phase 3 Trial. Diabetes Ther. 2022 Jun;13(6):1161-1174. doi: 10.1007/s13300-022-01262-8. Epub 2022 Apr 26.
PubMed 35471721
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog, LY2963016, to Lantus® in Combination With Mealtime Insulin Lispro in Adult Chinese Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03338023
- Acronym / sponsor ID
- 16036
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin Glargine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 29 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2963016 + Insulin Lispro | Experimental | Drug: LY2963016, Drug: Insulin LisproParticipants 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 | Active comparator | Drug: Lantus®, Drug: Insulin LisproParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have T1DM based on the disease diagnostic criteria (World Health Organization [WHO] Classification).
- Have duration of T1DM ≥1 year.
- Have HbA1c ≤11 %.
- Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening.
- Have a body mass index (BMI) ≤35 kilograms per meter squared.
Key exclusion criteria (14 listed)
- Exposure to an insulin glargine other than Lantus® within previous 30 days.
- Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study.
- Have known hypersensitivity or allergy to any of the study insulins (Lantus® or insulin lispro) or to excipients of the study insulins.
- Are pregnant, intend to become pregnant during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2963016Administered SC | Drug | LY2963016 + Insulin Lispro |
| Lantus®Administered SC | Drug | Lantus® + Insulin Lispro |
| Insulin LisproAdministered SC | Drug | LY2963016 + Insulin Lispro, Lantus® + Insulin Lispro |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®)
Time frame: Baseline, Week 24
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. 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).
12 secondary outcomes
Change From Baseline in HbA1c (Lantus® Noninferior to LY2963016)
Time frame: Baseline, Week 24
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
Time frame: Baseline, Week 24
Percentage of Participants With HbA1c <7%
Time frame: Week 24
Percentage of Participants With HbA1c ≤6.5%
Time frame: Week 24
Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG
Time frame: Baseline, Week 24
Change From Baseline in Glycemic Variability of Fasting Blood Glucose
Time frame: Baseline, Week 24
Change From Baseline in Basal Insulin Dose
Time frame: Baseline, Week 24
Change From Baseline in Prandial Insulin Dose
Time frame: Baseline, Week 24
Change From Baseline in Body Weight
Time frame: Baseline, Week 24
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ)
Time frame: Baseline, Week 24
Number of Participants With Detectable Anti-Glargine Antibodies
Time frame: Baseline through Week 24
Rate of Documented Symptomatic Hypoglycemia
Time frame: Baseline through Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35471721Yan X, Feng C, Lou Y, Zhou Z. Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (Lantus(R)): a Post Hoc Analysis of a Randomized, Open-Label, Phase 3 Trial. Diabetes Ther. 2022 Jun;13(6):1161-1174. doi: 10.1007/s13300-022-01262-8. Epub 2022 Apr 26.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and asigned data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY2963016, Lantus® and Insulin Lispro in people with Type 1 Diabetes, run by Eli Lilly and Company at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®) (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03338023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.