A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.

What Was Tested

This registered phase 1 trial tested Exenatide.

To explore the mechanism of action of ranolazine as a potential treatment for type 2 diabetes mellitus (T2DM).

It had two arms (groups): Placebo, Ranolazine, Exenatide (active comparator) and Ranolazine, Placebo, Exenatide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Males and females, 18 to 65 years old, inclusive. Documented history of T2DM for ≥5 years. Body mass index (BMI) 20.0 to 40.0 kg/m2, inclusive, at Screening. Stable treatment (≥ 12 weeks) with metformin alone, a sulfonylurea alone, a meglitinide alone, or a combination of metformin with either a sulfonylurea or a meglitinide. Fasting glucose within specific ranges, at Screening and after 14 +/-2 days of wash-out from prior oral anti-diabetic agents.

The full record lists 10 inclusion and 28 exclusion criteria; among the exclusions: history of type 1 diabetes mellitus or secondary forms of diabetes; history of acute diabetes complications; uncontrolled hypertension.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

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

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

In this single-blind Exenatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2013-04 with completion listed for 2013-09.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the concentration-time curve (AUC) of plasma glucagon during the standard meal test (SMT) (time frame: Days 5, 10, and 14).

It also tracked 9 secondary outcomes, for example Plasma glucose, serum insulin, and serum C-peptide AUCs during the SMT, Collapse under Acetaminophen PK, Area under the plasma acetaminophen concentration-time curve from time 0 to 240 min (AUC0-240 min), Trough plasma ranolazine concentrations (Ctrough), Apparent elimination half-life (t1/2) of ranolazine and Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 24 people.

Its size is small, so on its own it can only give an early look.

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

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