Skip to main content
OpenTrials
Completed

NCT Number: NCT04663282

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Core Research Group Pty Ltd, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INS068 injection

Drug

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

insulin degludec

Drug

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

Primary outcomes

  1. Change in HbA1c

    Time frame: Week 0 to Week 16

    Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment

Secondary outcomes

  1. Proportion of subjects reaching HbA1c targets

    Time frame: Week 0 to Week 16

    HbA1c <7% or HbA1c ≤6.5%

  2. Change in FPG

    Time frame: Week 0 to Week 16

    Change from baseline in FPG after 16 weeks of treatment

  3. 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.

  4. Pre-breakfast SMPG

    Time frame: Week 0 to Week 16

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

  5. Titration target

    Time frame: Week 0 to Week 16

    Proportion of subjects and time reaching titration targets

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. Changes in Body Weight

    Time frame: Week 0 to Week 16

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

  11. 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

  12. 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)

  13. Serum INS068 concentration

    Time frame: Week 0 to Week 16

    To evaluate PK of INS068

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2020
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.