Type 2 DiabetesPhase 3NCT03338010
A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus
A Phase 3 study testing LY2963016 and Lantus® in people with Type 2 Diabetes, run by Eli Lilly and Company at 32 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- LY2963016 and Lantus®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 32 sitesChina
- Study dates
- 22 Mar 2018to 18 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 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites
Peking Union Medical College Hospital
Beijing, 88798
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, 130041
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Chongqing General Hospital
Chongqing, 400013
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
Anhui Provincial Hospital
Hefei, Anhui, 230001
The Affliated Jiangyin Hospital of Southeast University Medical College
Jiangyin, Jiangsu, 214400
Jinan Central Hospital
Jinan, Shandong, 250013
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000
The 1st Affiliated Hospital of Henan Science and technology
Luoyang, Henan, 471003
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
Nanjing, Jiangsu, 210008
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Nanjing First Hospital
Nanjing, Jiangsu, 210012
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211199
The First Affiliated Hospital with Nanjing Medical Universit
Nanjing, Nanjing, 210029
Shanghai Putuo District Center Hospital
Shanghai, 200062
Shantou University Medical College No.2 Affiliated Hospital
Shantou, Guangdong, 515041
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110022
Siping central people's hospital
Siping, Jilin, 136000
1st affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Tianjin Medical University General Hospital
Tianjin, 300052
Wuhan Central Hospital
Wuhan, Hubei, 430014
Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
Wuhan, Hubei, 430030
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Xuzhou central Hospital
Xuzhou, Jiangsu, 221009
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
The First People Hospital of Yueyang
Yueyang, Hunan, 414000
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 Adult Chinese Patients With Type 2 Diabetes Mellitus
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.
- Conditions
- Type 2 Diabetes
- Being tested
- LY2963016, Lantus®
- Keywords
- Insulin glargine
- Medical subject headings
- Diabetes Mellitus, Type 2
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
| Study group | Role | What they receive |
|---|---|---|
| LY2963016 | Experimental | 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). Receives: Drug: LY2963016 |
| Lantus® | Active comparator | 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. Receives: Drug: Lantus® |
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 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.
Measured: Baseline, Week 24
Secondary outcomes (11)
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.
Measured: Baseline, Week 24
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.
Measured: Baseline, Week 24
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.
Measured: Week 24
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.
Measured: Week 24
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.
Measured: Baseline, Week 24
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.
Measured: At Week 24
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.
Measured: Baseline, Week 24
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.
Measured: Baseline, Week 24
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.
Measured: At Week 24
Number of Participants With Detectable Anti-Glargine Antibodies
Number of participants with detectable anti-glargine antibodies were reported.
Measured: Baseline through 24 weeks
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.
Measured: Baseline through 24 weeks
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 start22 Mar 2018
- Primary completion18 Mar 2020
- Study completion18 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.
- Other trials for Type 2 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
- 536 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
- NCT03338010
- Sponsor's protocol ID
- 16037
- Other IDs
- I4L-GH-ABET
- Status last verified
- May 2021
- First submitted
- 7 Nov 2017
- Last updated
- 25 May 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 a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 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 Adult Chinese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03338010
- Acronym / sponsor ID
- 16037
- Conditions
- Type 2 Diabetes
- Keywords
- Insulin glargine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 25 May 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2963016 | Experimental | Drug: LY2963016Insulin 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). |
| Lantus® | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
| Lantus®Administered SC | Drug | Lantus® |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)
Time frame: Baseline, Week 24
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment*visit in the model.
11 secondary outcomes
Change From Baseline in HbA1c (Lantus® 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% at Week 24
Time frame: Week 24
Percentage of Participants With HbA1c ≤6.5% at Week 24
Time frame: Week 24
Change From Baseline in Glycemic Variability of Fasting Blood Glucose
Time frame: Baseline, Week 24
Basal Insulin Dose Units Per Day
Time frame: At Week 24
Change From Baseline in Basal Insulin Dose Units Per Day
Time frame: Baseline, Week 24
Change From Baseline in Body Weight
Time frame: Baseline, Week 24
Insulin Treatment Satisfaction Questionnaire (ITSQ)
Time frame: At Week 24
Number of Participants With Detectable Anti-Glargine Antibodies
Time frame: Baseline through 24 weeks
Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year)
Time frame: Baseline through 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 a signed data sharing agreement.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
32 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 and Lantus® in people with Type 2 Diabetes, run by Eli Lilly and Company at 32 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 4 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 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 25 May 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 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?
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 25 May 2021.