The main purpose of this study is to compare the benefits and risks associated with the use of 2 treatment strategies to lower blood sugar in participants aged 65 and older with T2DM. One strategy is based on the use of oral and injectable medications that only reduce blood sugar (glucose) when it is high. The other strategy is based on non-glucose dependent agents. The trial will last up to 72 weeks for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Administered orally
Administered orally
Administered orally
Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia
Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c \> upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c \> upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose \<3.0 mmol/L. Success is defined as lacking of failure.
Time frame: Baseline to last participant visit (up to 72 weeks)
Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy
Time frame: Baseline to last participant visit (up to 72 weeks)
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Time frame: Baseline to last participant visit (up to 72 weeks)
Change From Baseline of Urinary Albumin to Creatinine Ratio
The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease.
Time frame: Baseline, Week 72
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 72
Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)
The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.
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Administered orally
Administered orally
Administered orally
Administered subcutaneously (SC)
Administered SC
Administered SC
Administered SC
Suncoast Research Group, LLC
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Florida Hospital
Orlando, Florida, United States
Athens Primary Care
Athens, Georgia, United States
Herman Clinical Research, LLC
Suwanee, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Iderc, P.L.C.
Des Moines, Iowa, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Mercy Health Research
St Louis, Missouri, United States
...and 24 more locations
Time frame: Baseline, Week 72