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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
179
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial
Change in HbA1c
Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment
Time frame: Week 0 to Week 16
Proportion of subjects reaching HbA1c targets
HbA1c \<7% or HbA1c ≤6.5%
Time frame: Week 0 to Week 16
Change in FPG
Change from baseline in FPG after 16 weeks of treatment
Time frame: Week 0 to Week 16
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.
Time frame: Week 0 to Week 16
Pre-breakfast SMPG
Mean plasma glucose, Within-subject variability of pre-breakfast SMPG.
Time frame: Week 0 to Week 16
Titration target
Proportion of subjects and time reaching titration targets
Time frame: Week 0 to Week 16
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).
Time frame: Week 0 to Week 16
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National Research Institute - Huntington Park
Huntington Park, California, United States
Clinical Trials Research
Lincoln, California, United States
Torrance Clinical Research Institute Inc
Lomita, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Endocrinology Associates, Inc
Columbus, Ohio, United States
...and 25 more locations
Numbers of injection site reactions
The injection site reactions was assessed during the treatment period of 16 weeks.
Time frame: Week 0 to Week 16
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.
Time frame: Week 0 to Week 16 + 14 days follow-up
Anti-drug Antibodies: Anti-INS068 Antibodies
Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported.
Time frame: Week 0 to Week 16+14 days follow-up
Changes in Body Weight
Change of body weight was evaluated from Week 0 to Week 16
Time frame: Week 0 to Week 16
Changes in Body Mass Index
Change of Body Mass Index was evaluated from Week 0 to Week 16
Time frame: 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)
Time frame: Week 0 to Week 16
Serum INS068 concentration
To evaluate PK of INS068
Time frame: Week 0 to Week 16