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Completed

NCT Number: NCT02147431

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

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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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

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

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.

Primary outcomes

  1. Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L))

    Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

Secondary outcomes

  1. Change in mean glucagon concentration from target level 5.5 mmol/L to 3.5 mmoL/L and from ambient plasma glucose to target levels 5.5 mmol/L, 3.5 mmol/L and nadir

    Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

  2. Change in mean concentrations of adrenaline, noradrenaline, cortisol and growth hormone from target level 5.5 mmol/L to 3.5 mmol/L and to nadir

    Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

  3. Hypoglycaemic symptoms score

    Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

  4. Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L

    Time frame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Single-centre, Double-blind, Cross-over Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counter-regulation Compared to Placebo in Subjects With Type 2 Diabetes

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 26, 2014
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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