To Evaluate the Response to Glucagon During Hypoglycemia

What Was Tested

This registered phase 1 trial tested Glucagon.

The purpose of this study is to evaluate the response to Glucagon versus the spontaneous hormonal response to low blood sugar levels in T2DM Patients treated with AZD1656 and Metformin.

It had two arms (groups): 1 (experimental) and 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 8 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Type II diabetes patients, female with non child-bearing potential.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: history of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease; signs of diabetic proliferative retinopathy or diabetic maculopathy, at screening or on an ophthalmological examination within 3 months from start of study; participating in another clinical study during the last 30 days prior to enrolment.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

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

It started in 2009-02 with completion listed for 2009-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: P-Glucose levels (time frame: Repeated sampling during the 24 hour period on day 5 and 8).

It also tracked 3 secondary outcomes, for example Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 8 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 Glucagon compound page, all human trials.