Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 192
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants may receive oral and injectable (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) therapies that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks. arm 2: Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according treatment algorithm. Treatment may last up to 72 weeks.

Interventions: intervention 1: Glimepiride intervention 2: Metformin intervention 3: Pioglitazone intervention 4: Acarbose intervention 5: Linagliptin intervention 6: Sitagliptin intervention 7: Liraglutide intervention 8: Insulin Glargine intervention 9: Exenatide once weekly (QW) intervention 10: Exenatide twice daily (BID)
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally intervention 5: Administered orally intervention 6: Administered orally intervention 7: Administered subcutaneously (SC) intervention 8: Administered SC intervention 9: Administered SC intervention 10: Administered SC

Protocol document: