A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics

December 20, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

Evaluation of the Efficacy and Safety of INS068 Injection and Insulin Degludec Subcutaneous Injection Once Daily in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With One or Two Oral Antidiabetics (A Randomized, Open-Label, Two-Arm, Treat-to-Target, Parallel Controlled Trial)

The study is being conducted to evaluate the efficacy and safety of IND068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with one or two oral antidiabetics compared to insulin degludec QD for 16 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
179

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4064
        • Core Research Group Pty Ltd
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3081
        • Austin Health (Heidelberg Repatriation Hospital)
  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • The Second Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China, 404100
        • Chongqing University Three Gorges Hospital
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, China, 450000
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital Affiliated to Southeast University
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Shanghai Xuhui District Central Hospital
      • Shanghai, Shanghai, China, 200062
        • Shanghai Putuo District Central Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • First Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China Hospital，Sichuan University
      • Yibin, Sichuan, China, 644000
        • Yibin Second People's Hospital
  • United States
    • California
      • Huntington Park, California, United States, 90255
        • National Research Institute - Huntington Park
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
      • Lomita, California, United States, 90717
        • Torrance Clinical Research Institute Inc
      • Los Angeles, California, United States, 90057
        • National Research Institute - Wilshire
    • Florida
      • Cooper City, Florida, United States, 33024
        • ALL Medical Research, LLC
      • Hialeah, Florida, United States, 33016
        • New Generation of Medical Research
      • Miami, Florida, United States, 33014-3616
        • Clinical Pharmacology of Miami, LLC
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Endocrinology Associates, Inc
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
    • Texas
      • Houston, Texas, United States, 77040
        • Juno Research, LL
      • Houston, Texas, United States, 77074
        • Juno Research, LLC - Southwest Houston Site
      • Houston, Texas, United States, 77054
        • Juno Research, LLC - Medical Center Office
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that will not have been performed during normal management of the subject.)
  • Age is 18-75 years
  • Diagnosed with Type 2 diabetes (according to the diagnosis criteria applicable locally) for at least 3 months
  • Treatment with one or two oral anti-diabetic drug (OADs): metformin at astable daily dose of ≥ 1500 mg or maximum tolerated dose (at least 1000mg daily), with or without insulin secretagogue (SU or glinides) or DPP-4 inhibitors or SGLT-2 inhibitors or alpha-glucosidase inhibitors for at least 8 weeks at a stable dose. The dose(s) of OAD other than metformin should be minimum half of the daily maximal dose according to local labelling or maximum tolerated dose.
  • Insulin naïve. short-term insulin treatment (consecutive or cumulative treatment of ≤14 days) and insulin treatment for gestational diabetes are allowed.
  • HbA1c 7.0-10.0 % (53-85 mmol/mol) (both inclusive)
  • BMI 19-40 kg/m2 (both inclusive)

Exclusion Criteria:

  • Known or suspected allergy or intolerance to the active substance or to any of the excipients of the investigational medical products
  • Severe hypoglycemia during the previous 6 months.
  • Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months.
  • Cardiovascular disease within the last 12 months, defined as: stroke, decompensated heart failure (New York Heart Association [NYHA] class III or IV), myocardial infarction, or hospitalization for unstable angina pectoris or transient ischemic attack.
  • Diagnosis of malignant neoplasms (except basal cell or squamous cell skin cancer, polyps and in-situ carcinomas) within the last 5 years or increased risk of cancer or relapse of cancer.
  • Any antidiabetic medication other than permitted in the inclusion criteria or any weight-loss drug within the last 8 weeks..
  • Systemic or intra-articular corticosteroids treatment within the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: INS068
Intervention: Drug: INS068 injection
Drug: INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Active Comparator: IDeg
Intervention: Drug: insulin Degludec
Drug: Insulin Degludec
Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: Week 0 to Week 16
Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment
Week 0 to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects reaching HbA1c targets
Time Frame: Week 0 to Week 16
HbA1c <7% or HbA1c ≤6.5%
Week 0 to Week 16
Change in FPG
Time Frame: Week 0 to Week 16
Change from baseline in FPG after 16 weeks of treatment
Week 0 to Week 16
9-point SMPG profiles
Time Frame: Week 0 to Week 16
Mean plasma glucose, Postprandial and nocturnal increments, Fluctuation of 9-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Week 0 to Week 16
Pre-breakfast SMPG
Time Frame: Week 0 to Week 16
Mean plasma glucose, Within-subject variability of pre-breakfast SMPG.
Week 0 to Week 16
Titration target
Time Frame: Week 0 to Week 16
Proportion of subjects and time reaching titration targets
Week 0 to Week 16
Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication
Time Frame: Week 0 to Week 16
Classification of hypoglycaemia: Level 1(glucose level below 3.9 mmol/L), Level 2(glucose level below 3.0 mmol/L) and Level 3(Severe hypoglycemia, denotes severe cognitive impairment requiring external assistance for recovery).
Week 0 to Week 16
Numbers of injection site reactions
Time Frame: Week 0 to Week 16
The injection site reactions was assessed during the treatment period of 16 weeks.
Week 0 to Week 16
Frequency and severity of adverse events
Time Frame: Week 0 to Week 16 + 14 days follow-up
Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities, no or minimal medical treatment. Moderate: marked symptoms, interference with subject's daily activities，and medical treatment for alleviation without grave or permanent injury to the subject. . Severe: considerable interference with subject's daily activities， and intensive treatment and intervention needed.
Week 0 to Week 16 + 14 days follow-up
Anti-drug Antibodies: Anti-INS068 Antibodies
Time Frame: Week 0 to Week 16+14 days follow-up
Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported.
Week 0 to Week 16+14 days follow-up
Changes in Body Weight
Time Frame: Week 0 to Week 16
Change of body weight was evaluated from Week 0 to Week 16
Week 0 to Week 16
Changes in Body Mass Index
Time Frame: Week 0 to Week 16
Change of Body Mass Index was evaluated from Week 0 to Week 16
Week 0 to Week 16
Change in Health Related Quality of Life Questionnaire (SF -36)
Time Frame: Week 0 to Week 16
Change from baseline in scores of Health-Related Quality of Life Questionnaire after 16 weeks of treatment. The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score)
Week 0 to Week 16
Serum INS068 concentration
Time Frame: Week 0 to Week 16
To evaluate PK of INS068
Week 0 to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INS068-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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