A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide and Insulin Glargine.

The other strategy is based on non-glucose dependent agents.

It had two arms (groups): Strategy A (Glucose-Dependent) (experimental) and Strategy B (Reference) (active comparator).

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.

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.

The registry classes the interventions as drug.

Who Took Part

192 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 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).

The full record lists 12 inclusion and 15 exclusion criteria; among the exclusions: have previously completed or withdrawn from this study.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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2014-02 with completion listed for 2015-10.

It ran at 34 sites in United States (16), Germany (7), United Kingdom (5), Austria (4) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy, Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia, Change From Baseline of Urinary Albumin to Creatinine Ratio, Change From Baseline in Body Mass Index (BMI) and Change From Baseline of Estimated Glomerular Filtration Rate (eGFR).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Glargine in 192 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page and the Insulin Glargine compound page, all human trials.