A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Glimepiride; Metformin; Pioglitazone; Acarbose; Linagliptin; Sitagliptin; Liraglutide; Insulin Glargine; Exenatide once weekly (QW); Exenatide twice daily (BID)
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally; Administered orally; Administered orally; Administered subcutaneously (SC); Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Metformin; Insulin Glargine; Pioglitazone; Sitagliptin Phosphate; Liraglutide; Exenatide; Glimepiride; Linagliptin; Acarbose
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T2DM based on a history and clinical impression that is consistent with the World
             Health Organization (WHO) Classification of Diabetes

          -  Have a Clinical Frailty Scale (CFS) score of 4 or above or Total Illness Burden Index
             (TIBI) score of 5 or above as assessed at screening

          -  Have an A1c >7.3% and <10.9% at study entry and are not achieving desired glycemic
             control as evidenced by A1c measurement at least 0.4% higher than individualized
             treatment target set at screening.

          -  Have been treated for at least 3 months prior to the study entry with any of the
             following treatment options:

               -  Diet/exercise only (only if they have known contraindications to metformin
                  treatment)

               -  Any dose of sulfonylurea

               -  Effective or maximally-tolerated doses of metformin, dipeptidyl-peptidase-4
                  (DPP-4) inhibitor, thiazolidinedione, or acarbose used in monotherapy or in dual
                  combination. The following doses are considered to be effective:

                    -  at least 1500 mg of metformin per day

                    -  At least 30 mg of pioglitazone per day

                    -  At least 4 mg of rosiglitazone per day

                    -  At least 75 mg of acarbose per day

                    -  Any marketed dose of DPP-4 inhibitor

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving an investigational product or
             nonapproved use of a drug or device (other than the investigational product used in
             this study), or concurrently enrolled in any other type of medical research judged not
             to be scientifically or medically compatible with this study

          -  Have participated, within the last 60 days in a clinical trial involving an
             investigational product other than the investigational product used in this study. If
             the previous investigational product has a long half-life, 3 months or 5 half-lives
             (whichever is longer) should have passed

          -  Have previously completed or withdrawn from this study. This exclusion criterion does
             not apply to participants who are rescreened prior to randomization

          -  At study entry, have contraindications to sulfonylurea, insulin, or GLP-1 RA

          -  Have a history of pancreatitis, a personal or family history of medullary thyroid
             carcinoma, or have Multiple Endocrine Neoplasia syndrome type 2

          -  Have taken any injectable glucose-lowering agent, miglitol, meglitinide,
             Sodium/Glucose cotransporter-2 inhibitor, or other antihyperglycemia treatment that is
             not listed in the fourth inclusion criterion for more than 10 days within 3 months
             prior to the study entry

          -  In the opinion of investigator should have an individualized A1c target set at 8% or
             higher

          -  Have a body mass index (BMI) greater than 45 kg/m^2

          -  Have had more than 1 episode of severe hypoglycemia within 24 weeks prior to the study

          -  Have cardiac disease with functional status that is Class III or IV according to the
             New York Heart Association Cardiac Disease Classification

          -  Have an estimated glomerular filtration rate (eGFR) <30 milliliter/minute/1.73 m^2
             (mL/min/1.73 m^2) or advanced renal disease including history of renal transplantation
             or currently receiving renal dialysis

          -  Have obvious clinical signs or symptoms or laboratory evidence of liver disease
             (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 2.5 times the
             upper limit of the reference range)

          -  Receive current therapy for a malignancy, other than basal-cell or squamous-cell skin
             cancer

          -  Received systemic glucocorticoids within the 3 months prior to entry for more than 14
             consecutive days

          -  Have any other condition that precludes the participant from following and completing
             the study