A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
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|ClinicalTrials.gov Identifier: NCT04663282|
Recruitment Status : Completed
First Posted : December 10, 2020
Last Update Posted : December 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: INS068 injection Drug: Insulin Degludec||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||179 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||INS068 campared with Insulin degludec, both in Combination with One or Two Oral Antidiabetics|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||February 4, 2021|
|Actual Primary Completion Date :||May 28, 2022|
|Actual Study Completion Date :||May 28, 2022|
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
- Change in HbA1c [ Time Frame: Week 0 to Week 16 ]Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment
- Proportion of subjects reaching HbA1c targets [ Time Frame: Week 0 to Week 16 ]HbA1c <7% or HbA1c ≤6.5%
- Change in FPG [ Time Frame: Week 0 to Week 16 ]Change from baseline in FPG after 16 weeks of treatment
- 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.
- Pre-breakfast SMPG [ Time Frame: Week 0 to Week 16 ]Mean plasma glucose, Within-subject variability of pre-breakfast SMPG.
- Titration target [ Time Frame: Week 0 to Week 16 ]Proportion of subjects and time reaching titration targets
- 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).
- 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.
- 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.
- 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.
- Changes in Body Weight [ Time Frame: Week 0 to Week 16 ]Change of body weight was evaluated from 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
- 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)
- Serum INS068 concentration [ Time Frame: Week 0 to Week 16 ]To evaluate PK of INS068
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663282
|Responsible Party:||Jiangsu HengRui Medicine Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||December 10, 2020 Key Record Dates|
|Last Update Posted:||December 21, 2022|
|Last Verified:||January 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs