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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04663282
Collaborator
(none)
179
Enrollment
33
Locations
2
Arms
16.7
Anticipated Duration (Months)
5.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: INS068 injection
  • Drug: Insulin Degludec
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
179 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
INS068 campared with Insulin degludec, both in Combination with One or Two Oral AntidiabeticsINS068 campared with Insulin degludec, both in Combination with One or Two Oral Antidiabetics
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Feb 4, 2021
Anticipated Primary Completion Date :
Jun 27, 2022
Anticipated Study Completion Date :
Jun 27, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c [Week 0 to Week 16]

    Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment

Secondary Outcome Measures

  1. Proportion of subjects reaching HbA1c targets [Week 0 to Week 16]

    HbA1c <7% or HbA1c ≤6.5%

  2. Change in FPG [Week 0 to Week 16]

    Change from baseline in FPG after 16 weeks of treatment

  3. 9-point SMPG profiles [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 [Week 0 to Week 16]

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

  5. Titration target [Week 0 to Week 16]

    Proportion of subjects and time reaching titration targets

  6. Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication [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 [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 [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 [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 [Week 0 to Week 16]

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

  11. Changes in Body Mass Index [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) [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 [Week 0 to Week 16]

    To evaluate PK of INS068

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Research Institute - Huntington Park Huntington Park California United States 90255
2 Clinical Trials Research Lincoln California United States 95648
3 Torrance Clinical Research Institute Inc Lomita California United States 90717
4 National Research Institute - Wilshire Los Angeles California United States 90057
5 ALL Medical Research, LLC Cooper City Florida United States 33024
6 New Generation of Medical Research Hialeah Florida United States 33016
7 Clinical Pharmacology of Miami, LLC Miami Florida United States 33014-3616
8 Progressive Medical Research Port Orange Florida United States 32127
9 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
10 Endocrinology Associates, Inc Columbus Ohio United States 43201
11 Juno Research, LL Houston Texas United States 77040
12 Juno Research, LLC - Medical Center Office Houston Texas United States 77054
13 Juno Research, LLC - Southwest Houston Site Houston Texas United States 77074
14 Endeavor Clinical Trials San Antonio Texas United States 78229
15 The Royal Melbourne Hospital Melbourne Victoria Australia 3050
16 Austin Health (Heidelberg Repatriation Hospital) Melbourne Victoria Australia 3081
17 Peking University People's Hospital Beijing Beijing China 100044
18 The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400010
19 Chongqing University Three Gorges Hospital Chongqing Chongqing China 404100
20 Hainan General Hospital Haikou Hainan China 570311
21 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China 050000
22 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450000
23 Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology Wuhan Hubei China 430030
24 Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu China 210008
25 Zhongda Hospital Affiliated to Southeast University Nanjing Jiangsu China 210009
26 Jiangxi Provincial People's Hospital Nanchang Jiangxi China 330006
27 Shengjing Hospital Of China Medical University Shenyang Liaoning China 110004
28 The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710004
29 Shanghai Xuhui District Central Hospital Shanghai Shanghai China 200031
30 Shanghai Putuo District Central Hospital Shanghai Shanghai China 200062
31 First Hospital of Shanxi Medical University Taiyuan Shanxi China 030001
32 West China Hospital,Sichuan University Chengdu Sichuan China 610000
33 Yibin Second People's Hospital Yibin Sichuan China 644000

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04663282
Other Study ID Numbers:
  • INS068-201
First Posted:
Dec 10, 2020
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin

Study Results

No Results Posted as of Jan 28, 2022