Type 2 Diabetes MellitusPhase 4CLASSICNCT03018938
A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus
A Phase 4 study testing Insulin Analog Mid Mixture and Basal Insulin Analog in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 32 sites in China.
Trial summary
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin Analog Mid Mixture and Basal Insulin Analog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 32 sitesChina
- Study dates
- 6 Feb 2017to 12 Jul 2019
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have type 2 diabetes as defined by World Health Organization (WHO) criteria
- are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
- most recent HbA1c value ≥7.5% within 12 weeks of study entry
- in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
- willing to start with insulin treatment
Who cannot join
- have a diagnosis of type 1 diabetes
- have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
- have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
- are pregnant or breastfeeding, or intend to become pregnant during the course of the study
- are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites
Beijing Huaxin Hospital
Beijing, Beijing Municipality, 100016
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044
Beijing LuHe Hospital Capital Medical University
Beijing, Tongzhou, 101149
Peking University International Hospital
Beijing, 102206
Beijing Hai Dian Hospital
Beijing
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003
China Meitan General Hospital
Chaoyang, Beijing Municipality, 100028
The Third Affiliated Hospital of Chengdu University of TCM
Chengdu, Sichuan, 610041
Beijing Yanhua hospital
Fangshan, Beijing Municipality, 102500
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
The 2nd Hospital of Lanzhou University
Lanzhou, Gansu, 730030
The 1st Affiliated Hospital of Henan Science and technology
Luoyang, Henan, 471003
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, 646000
Affiliated Hospital of North Sichuan Medical College
Nanchong, Shunqing, 637000
Nanjing TCM hospital
Nanjing, Jiangsu, 210001
Jiang Su Province Official Hospital
Nanjing, Jiangsu, 210024
Nanjing Jiangbei Hospital
Nanjing, Jiangsu, 210048
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211100
Tianjin First Central Hospital
Nankai, Tianjin Municipality, 300192
Ningbo First Hospital
Ningbo, Zhejiang, 315010
Qingdao Municipal Hospital
Qingdao, Shandong, 266071
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality, 200135
Shanghai Pudong New District Zhoupu Hospital
Shanghai, Shanghai Municipality, 201318
Shanghai Yangpu District Central Hospital
Shanghai, 200090
Shenzhen City People Hospital
Shenzhen, Guangdong, 518020
Taian City Central Hospital
Taian, Shandong, 271000
Taizhou City People Hospital
Taizhou, Jiangsu, 225300
Wuhan Union (Xiehe) Hospital
Wuhan, Hubei, 430022
The second People's hospital of Wuxi
Wuxi, Jiangsu, 214000
Xuzhou central Hospital
Xuzhou, Jiangsu, 221009
The 1st Hospital with Guangdong Pharmaceutical University
Yuexiu, Guangdong, 510080
People's Hospital of Henan Province
Zhengzhou, Henan, 450003
About this study
Official title: Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study)
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin Analog Mid Mixture, Basal Insulin Analog
- Keywords
- mid mixture insulin analog, basal insulin analog
- 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.
Insulin Analog Mid MixtureDrug
Administered SC
Basal Insulin AnalogDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Insulin Analog Mid Mixture | Experimental | Insulin analog mid mixture given subcutaneously (SC). Receives: Drug: Insulin Analog Mid Mixture |
| Basal Insulin Analog | Experimental | Basal insulin analog given SC. Receives: Drug: Basal Insulin Analog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
Measured: Baseline, 24 Weeks
Secondary outcomes (15)
Change From Baseline to Week 48 in HbA1c
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
Measured: Baseline, 48 Weeks
Percentage of Participants Who Achieve HbA1c <7% at Week 24
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: 24 Weeks
Percentage of Participants Who Achieve HbA1c <7% at Week 48
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: 48 Weeks
Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
Measured: Baseline, 24 Weeks
Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
Measured: Baseline, 48 Weeks
Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
Measured: Baseline, 24 Weeks
Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
Measured: Baseline, 48 Weeks
Total Daily Insulin Dose at Week 24 and 48
Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
Measured: 24 Weeks, 48 Weeks
Change From Baseline to Week 24 in Body Weight
LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
Measured: Baseline, 24 Weeks
Change From Baseline to Week 48 in Body Weight
LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
Measured: Baseline, 48 Weeks
Rate of Hypoglycemia at Week 24 and 48
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: 24 Weeks, 48 Weeks
Number of Participants With Insulin Treatment Change at Week 48
Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.
- Discontinuation: Defined as stopping insulin treatment for 30 days or more.
- Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.
- Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group
- Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.
Measured: Baseline through 48 Weeks
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
Measured: 24 Weeks
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
Measured: 48 Weeks
Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.
Measured: Baseline, 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start6 Feb 2017
- Primary completion19 Feb 2019
- Study completion12 Jul 2019
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 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 814 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
- NCT03018938
- Sponsor's protocol ID
- 16507
- Other IDs
- F3Z-GH-IOQR
- Acronym
- CLASSIC
- Status last verified
- 15 Aug 2019
- First submitted
- 11 Jan 2017
- Last updated
- 18 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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.
Publications
Zeng T, Yuan H, Ren J, Li Y, Hou J, Du L, Zhu J, Chen L, Ji L. A Pragmatic Study of Basal and Mid-Mixture Insulins as Starter Insulins in Chinese Patients With Type 2 Diabetes: Observations From Long-Term, Real-World Experience. Diabetes Ther. 2021 Mar;12(3):931-941. doi: 10.1007/s13300-021-01007-z. Epub 2021 Feb 22.
PubMed 33616875
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study)
- ClinicalTrials.gov ID
- NCT03018938
- Acronym / sponsor ID
- CLASSIC / 16507
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- mid mixture insulin analog, basal insulin analog
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Posted 18 Mar 2020
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 the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Analog Mid Mixture | Experimental | Drug: Insulin Analog Mid MixtureInsulin analog mid mixture given subcutaneously (SC). |
| Basal Insulin Analog | Experimental | Drug: Basal Insulin AnalogBasal insulin analog given SC. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have type 2 diabetes as defined by World Health Organization (WHO) criteria
- are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
- most recent HbA1c value ≥7.5% within 12 weeks of study entry
- in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
- willing to start with insulin treatment
Key exclusion criteria (5 listed)
- have a diagnosis of type 1 diabetes
- have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
- have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
- are pregnant or breastfeeding, or intend to become pregnant during the course of the study
- are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
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 |
|---|---|---|
| Insulin Analog Mid MixtureAdministered SC | Drug | Insulin Analog Mid Mixture |
| Basal Insulin AnalogAdministered SC | Drug | Basal Insulin Analog |
Primary outcome
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 24 Weeks
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
15 secondary outcomes
Change From Baseline to Week 48 in HbA1c
Time frame: Baseline, 48 Weeks
Percentage of Participants Who Achieve HbA1c <7% at Week 24
Time frame: 24 Weeks
Percentage of Participants Who Achieve HbA1c <7% at Week 48
Time frame: 48 Weeks
Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
Time frame: Baseline, 24 Weeks
Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
Time frame: Baseline, 48 Weeks
Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Time frame: Baseline, 24 Weeks
Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Time frame: Baseline, 48 Weeks
Total Daily Insulin Dose at Week 24 and 48
Time frame: 24 Weeks, 48 Weeks
Change From Baseline to Week 24 in Body Weight
Time frame: Baseline, 24 Weeks
Change From Baseline to Week 48 in Body Weight
Time frame: Baseline, 48 Weeks
Rate of Hypoglycemia at Week 24 and 48
Time frame: 24 Weeks, 48 Weeks
Number of Participants With Insulin Treatment Change at Week 48
Time frame: Baseline through 48 Weeks
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
Time frame: 24 Weeks
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
Time frame: 48 Weeks
Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
Time frame: Baseline, 48 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33616875Zeng T, Yuan H, Ren J, Li Y, Hou J, Du L, Zhu J, Chen L, Ji L. A Pragmatic Study of Basal and Mid-Mixture Insulins as Starter Insulins in Chinese Patients With Type 2 Diabetes: Observations From Long-Term, Real-World Experience. Diabetes Ther. 2021 Mar;12(3):931-941. doi: 10.1007/s13300-021-01007-z. Epub 2021 Feb 22.
- 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.
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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
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Analog Mid Mixture and Basal Insulin Analog in people with Type 2 Diabetes Mellitus, 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 5 inclusion and 5 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 18 Mar 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 18 Mar 2020). 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 to Week 24 in Hemoglobin A1c (HbA1c) (time frame: Baseline, 24 Weeks). 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 NCT03018938, 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 18 Mar 2020.