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Type 2 DiabetesPhase 2NCT04663282

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

A Phase 2 study testing INS068 injection and Insulin Degludec in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 35 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
INS068 injection and Insulin Degludec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
35 sitesin 3 countries
Study dates
4 Feb 2021to 28 May 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

35 sites in 3 countries.

35 sites in 3 countries

China17 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610000

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404100

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Affiliated to Southeast University

    Nanjing, Jiangsu, 210009

  • Shanghai Xuhui District Central Hospital

    Shanghai, Shanghai Municipality, 200031

  • Shanghai Putuo District Central Hospital

    Shanghai, Shanghai Municipality, 200062

  • Shengjing Hospital Of China Medical University

    Shenyang, Liaoning, 110004

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology

    Wuhan, Hubei, 430030

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

  • Yibin Second People's Hospital

    Yibin, Sichuan, 644000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

Other trials in China

United States15 sites

  • Endocrinology Associates, Inc

    Columbus, Ohio, 43201

  • ALL Medical Research, LLC

    Cooper City, Florida, 33024

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • New Generation of Medical Research

    Hialeah, Florida, 33016

  • Juno Research, LL

    Houston, Texas, 77040

  • Juno Research, LLC - Medical Center Office

    Houston, Texas, 77054

  • Juno Research, LLC - Southwest Houston Site

    Houston, Texas, 77074

  • National Research Institute - Huntington Park

    Huntington Park, California, 90255

  • Clinical Trials Research

    Lincoln, California, 95648

  • Torrance Clinical Research Institute Inc

    Lomita, California, 90717

  • National Research Institute - Wilshire

    Los Angeles, California, 90057

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida, 33014-3616

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Endeavor Clinical Trials

    San Antonio, Texas, 78229

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

Other trials in United States

Australia3 sites

  • Core Research Group Pty Ltd

    Brisbane, Queensland, 4064

  • The Royal Melbourne Hospital

    Melbourne, Victoria, 3050

  • Austin Health (Heidelberg Repatriation Hospital)

    Melbourne, Victoria, 3081

Other trials in Australia

About this study

Official title: 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.

Conditions
Type 2 Diabetes
Being tested
INS068 injection, Insulin Degludec
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.

  • INS068 injectionDrug

    INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial

  • Insulin DegludecDrug

    Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial

Study groups in NCT04663282
Study groupRoleWhat they receive
INS068ExperimentalIntervention: Drug: INS068 injection
Receives: Drug: INS068 injection
IDegActive comparatorIntervention: Drug: insulin Degludec
Receives: Drug: Insulin Degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment

    Measured: Week 0 to Week 16

Secondary outcomes (13)

  1. Proportion of subjects reaching HbA1c targets

    HbA1c <7% or HbA1c ≤6.5%

    Measured: Week 0 to Week 16

  2. Change in FPG

    Change from baseline in FPG after 16 weeks of treatment

    Measured: Week 0 to Week 16

  3. 9-point SMPG profiles

    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.

    Measured: Week 0 to Week 16

  4. Pre-breakfast SMPG

    Mean plasma glucose, Within-subject variability of pre-breakfast SMPG.

    Measured: Week 0 to Week 16

  5. Titration target

    Proportion of subjects and time reaching titration targets

    Measured: Week 0 to Week 16

  6. Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication

    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).

    Measured: Week 0 to Week 16

  7. Numbers of injection site reactions

    The injection site reactions was assessed during the treatment period of 16 weeks.

    Measured: Week 0 to Week 16

  8. Frequency and severity of adverse events

    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.

    Measured: Week 0 to Week 16 + 14 days follow-up

  9. Anti-drug Antibodies: Anti-INS068 Antibodies

    Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported.

    Measured: Week 0 to Week 16+14 days follow-up

  10. Changes in Body Weight

    Change of body weight was evaluated from Week 0 to Week 16

    Measured: Week 0 to Week 16

  11. Changes in Body Mass Index

    Change of Body Mass Index was evaluated from Week 0 to Week 16

    Measured: Week 0 to Week 16

  12. Change in Health Related Quality of Life Questionnaire (SF -36)

    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)

    Measured: Week 0 to Week 16

  13. Serum INS068 concentration

    To evaluate PK of INS068

    Measured: Week 0 to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2020
  2. Study start4 Feb 2021
  3. Primary completion28 May 2022
  4. Study completion28 May 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
INS068 campared with Insulin degludec, both in Combination with One or Two Oral Antidiabetics
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04663282
Sponsor's protocol ID
INS068-201
Status last verified
Jan 2022
First submitted
2 Dec 2020
Last updated
21 Dec 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INS068 injection and Insulin Degludec in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 35 sites in 3 countries.

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 7 inclusion and 7 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 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in China, United States, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in HbA1c (time frame: Week 0 to Week 16). 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 NCT04663282.

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 21 Dec 2022.

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