The TRENT trial is designed to confirm the efficacy and safety of Gla-300 compared with IDeg-100 in insulin-naïve patient (participants who have not tried insulin) with Type 2 Diabetes Mellitus (T2DM) and renal impairment. It will test the hypothesis that Gla-300 is non-inferior to IDeg-100 with glucose control. If achieved, the trial will also test for the superiority of Gla-300 compared with IDeg-100 in Hemoglobin A1c (HbA1c) reduction, without an increased potential risk of hypoglycemia.
The trial will consist of the following periods: * A screening period of up to 2 weeks, * A 24-week, open-label treatment period, including a titration period and a maintenance period. * A 7-day, post-treatment, safety follow-up period after the last dose of the study drug or after premature/permanent discontinuation from study drug treatment. This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Insulin glargine 300 U/mL in the SoloStar pen, self-administered once daily for 24 weeks.
Insulin degludec 100 U/mL will be self- administered once daily for 24 weeks.
Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100)
Change in HbA1c was calculated by subtracting baseline value from Week 24 value and then mean values were calculated.
Time frame: Baseline to 24 weeks
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
Change in FPG was calculated by subtracting baseline value from the Week 24 value.
Time frame: Baseline to 24 weeks
Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24
Change in SMPG was calculated by subtracting baseline value from the Week 24 value.
Time frame: Baseline to 24 weeks
Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period
7-point SMPG profiles were measured at the following 7 points: pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.
Time frame: Baseline to 24 weeks
Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24
If a patient has a missing HbA1c value at Week 24, it is assumed that they did not reach the HbA1c target of \<7.0%. HbA1c value of 7.0% is equivalent to 53.0 mmol/mol.
Time frame: At week 24
Percentage of Participants With ≥1 Episode(s) of Confirmed Hypoglycemia Event (Cut-off Value 70 mg/dL and 54 mg/dL) During the 24-week Treatment Period.
Any event recorded with Yes as response to the question, "Was a glucose measurement obtained at the time of the event before countermeasure?" and a measurable glucose level of \<70 mg/dL. ADA (American Diabetes Association), Level 1 was defined as a measurable glucose concentration of \<70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L).
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Yuma Clinical Trials, LLC Site Number: 8400028
Yuma, Arizona, United States
American Clinical Trials Site Number: 8400014
Buena Park, California, United States
Clearview Medical Research LLC Site Number: 8400021
Canyon Country, California, United States
Torrance Clinical Research Institute Site Number: 8400003
Lomita, California, United States
Center for Endocrinology Diabetes and Metabolic Disorders (CEDMD) - CAR Site Number: 8400026
Santa Clarita, California, United States
San Fernando Valley Health Institute - ClinEdge - PPDS Site Number: 8400023
Van Nuys, California, United States
Chase Medical Research LLC Site Number: 8400007
Waterbury, Connecticut, United States
Innovative Research of West Florida Site Number: 8400016
Clearwater, Florida, United States
Evolution Clinical Trials Site number: 8400034
Hialeah Gardens, Florida, United States
Wellness Research Center Inc - Miami Site Number: 8400010
Miami, Florida, United States
...and 58 more locations
Time frame: Baseline to end of study (25 weeks)
Rate of Hypoglycemia Per Participant-year
Computed as: 365.25/12 × (number of episodes of hypoglycemia)/(number of days exposed in time window)
Time frame: Baseline to end of study (25 weeks)]
Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks)
Hypoglycemic events measured at the following intervals: Weeks 1-12 and Weeks 13-24.
Time frame: Baseline to end of study (25 weeks)
The 24-hour (All Time), Occurrence of Each Episode of Documented Hypoglycemia by Category, Presented by 2-hour Timeframe Over 24 Hours During the 24-week Treatment Period.
The time range for this outcome measure was 00:00 to 05:59, both inclusive. Hypoglycemia Categories \[(symptomatic, asymptomatic, severe) are defined per the American Diabetes Association/European Association for the Study of Diabetes hypoglycemia Classification\]
Time frame: Baseline to end of study (25 weeks)
Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs)
Adverse events (AEs) and serious adverse events (SAEs), including adverse events of special interest (AESIs), and other safety evaluations, including vital signs and body weight.
Time frame: Baseline to end of study (25 weeks)