search
Back to results

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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INS068 injection
Insulin Degludec
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Research Institute - Huntington Park
  • Clinical Trials Research
  • Torrance Clinical Research Institute Inc
  • National Research Institute - Wilshire
  • ALL Medical Research, LLC
  • New Generation of Medical Research
  • Clinical Pharmacology of Miami, LLC
  • Progressive Medical Research
  • Iowa Diabetes and Endocrinology Research Center
  • Endocrinology Associates, Inc
  • Prestige Clinical Research
  • Juno Research, LL
  • Juno Research, LLC - Medical Center Office
  • Juno Research, LLC - Southwest Houston Site
  • Endeavor Clinical Trials
  • Core Research Group Pty Ltd
  • The Royal Melbourne Hospital
  • Austin Health (Heidelberg Repatriation Hospital)
  • Peking University People's Hospital
  • The Second Affiliated Hospital of Chongqing Medical University
  • Chongqing University Three Gorges Hospital
  • Hainan General Hospital
  • The Second Hospital of Hebei Medical University
  • The First Affiliated Hospital of Zhengzhou University
  • Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology
  • Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
  • Zhongda Hospital Affiliated to Southeast University
  • Jiangxi Provincial People's Hospital
  • Shengjing Hospital Of China Medical University
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Shanghai Xuhui District Central Hospital
  • Shanghai Putuo District Central Hospital
  • First Hospital of Shanxi Medical University
  • West China Hospital,Sichuan University
  • Yibin Second People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

INS068

IDeg

Arm Description

Intervention: Drug: INS068 injection

Intervention: Drug: insulin Degludec

Outcomes

Primary Outcome Measures

Change in HbA1c
Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment

Secondary Outcome Measures

Proportion of subjects reaching HbA1c targets
HbA1c <7% or HbA1c ≤6.5%
Change in FPG
Change from baseline in FPG after 16 weeks of treatment
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.
Pre-breakfast SMPG
Mean plasma glucose, Within-subject variability of pre-breakfast SMPG.
Titration target
Proportion of subjects and time reaching titration targets
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).
Numbers of injection site reactions
The injection site reactions was assessed during the treatment period of 16 weeks.
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.
Anti-drug Antibodies: Anti-INS068 Antibodies
Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported.
Changes in Body Weight
Change of body weight was evaluated from Week 0 to Week 16
Changes in Body Mass Index
Change of Body Mass Index was evaluated from Week 0 to Week 16
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)
Serum INS068 concentration
To evaluate PK of INS068

Full Information

First Posted
December 2, 2020
Last Updated
December 20, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04663282
Brief Title
A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
May 28, 2022 (Actual)
Study Completion Date
May 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
INS068 campared with Insulin degludec, both in Combination with One or Two Oral Antidiabetics
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INS068
Arm Type
Experimental
Arm Description
Intervention: Drug: INS068 injection
Arm Title
IDeg
Arm Type
Active Comparator
Arm Description
Intervention: Drug: insulin Degludec
Intervention Type
Drug
Intervention Name(s)
INS068 injection
Intervention Description
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec
Intervention Description
Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment
Time Frame
Week 0 to Week 16
Secondary Outcome Measure Information:
Title
Proportion of subjects reaching HbA1c targets
Description
HbA1c <7% or HbA1c ≤6.5%
Time Frame
Week 0 to Week 16
Title
Change in FPG
Description
Change from baseline in FPG after 16 weeks of treatment
Time Frame
Week 0 to Week 16
Title
9-point SMPG profiles
Description
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.
Time Frame
Week 0 to Week 16
Title
Pre-breakfast SMPG
Description
Mean plasma glucose, Within-subject variability of pre-breakfast SMPG.
Time Frame
Week 0 to Week 16
Title
Titration target
Description
Proportion of subjects and time reaching titration targets
Time Frame
Week 0 to Week 16
Title
Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication
Description
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).
Time Frame
Week 0 to Week 16
Title
Numbers of injection site reactions
Description
The injection site reactions was assessed during the treatment period of 16 weeks.
Time Frame
Week 0 to Week 16
Title
Frequency and severity of adverse events
Description
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.
Time Frame
Week 0 to Week 16 + 14 days follow-up
Title
Anti-drug Antibodies: Anti-INS068 Antibodies
Description
Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported.
Time Frame
Week 0 to Week 16+14 days follow-up
Title
Changes in Body Weight
Description
Change of body weight was evaluated from Week 0 to Week 16
Time Frame
Week 0 to Week 16
Title
Changes in Body Mass Index
Description
Change of Body Mass Index was evaluated from Week 0 to Week 16
Time Frame
Week 0 to Week 16
Title
Change in Health Related Quality of Life Questionnaire (SF -36)
Description
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)
Time Frame
Week 0 to Week 16
Title
Serum INS068 concentration
Description
To evaluate PK of INS068
Time Frame
Week 0 to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Torrance Clinical Research Institute Inc
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
ALL Medical Research, LLC
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
New Generation of Medical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Clinical Pharmacology of Miami, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33014-3616
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Endocrinology Associates, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Juno Research, LL
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Juno Research, LLC - Medical Center Office
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Juno Research, LLC - Southwest Houston Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Core Research Group Pty Ltd
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Austin Health (Heidelberg Repatriation Hospital)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
Chongqing University Three Gorges Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404100
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Zhongda Hospital Affiliated to Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Shengjing Hospital Of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Name
Shanghai Xuhui District Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Shanghai Putuo District Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
Yibin Second People's Hospital
City
Yibin
State/Province
Sichuan
ZIP/Postal Code
644000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs