Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Exenatide and Insulin Glargine.

This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.

It had three arms (groups): insulin glargine + exenatide + metformin (experimental), Insulin glargine + sitagliptin + metformin (experimental) and insulin glargine + metformin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Thus, in the present study the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal insulin (insulin glargine) was investigated versus insulin glargine alone as active comparator in subjects with type 2 diabetes.

Preexisting metformin was continued, sulfonylureas, if any, were stopped.

The study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in period, a 4-week treatment period, and a follow-up visit.

There were weekly visits at the site and twice weekly telephone contacts.

Who Took Part

Enrollment: 48 actual participants took part.

It was open to people of any sex aged from 35 years up to 70 years.

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

Examples of who could join: Male or female subjects aged between 35 and 70 years, inclusive. Type 2 diabetes with duration \>6 months and \<10 years. If treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start. Written informed consent.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: history or presence of cancer or any clinically relevant diseases; chronic heart failure nyha class iii or iv, unstable angina pectoris or myocardial infarction within the previous 6 months; recurrent hypoglycemia.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

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 2008-01 with completion listed for 2008-09.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast (time frame: after 4 weeks of treatment).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide and Insulin Glargine in 48 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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