A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-21

Study Completion Date

2015-05-20

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to investigate the effect of semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Semaglutide

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

2 periods of 12 weeks of once weekly dosing with multiple doses of semaglutide, for subcutaneous (s.c., under the skin) injection, escalated up to 1.0 mg semaglutide.

Each treatment period will be followed by a hypoglycaemic clamp

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

2 periods of 12 weeks of once weekly dosing, subcutaneous (s.c., under the skin) injection.

Each treatment period will be followed by a hypoglycaemic clamp.

Interventions

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semaglutide

2 periods of 12 weeks of once weekly dosing with multiple doses of semaglutide, for subcutaneous (s.c., under the skin) injection, escalated up to 1.0 mg semaglutide.

Each treatment period will be followed by a hypoglycaemic clamp

Intervention Type DRUG

placebo

2 periods of 12 weeks of once weekly dosing, subcutaneous (s.c., under the skin) injection.

Each treatment period will be followed by a hypoglycaemic clamp.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. Stable is defined as unchanged dose
* Male or female, age between18-64 years (both inclusive) at the time of signing informed consent
* Body Mass Index (BMI) between 20.0-35.0 kg/m\^2 (both inclusive)
* HbA1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive)

Exclusion Criteria

* Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. An exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Blood or plasma donation within the past month or more than 500 mL within the last 3 months prior to first semaglutide dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No