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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: placebo; Drug: semaglutide

• Registration Number: NCT02147431
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-21
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-26
• Primary Completion: 2015-05-20
• Study Completion: 2015-05-20
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Semaglutide	semaglutide	-

Primary Outcome Measures

Name	Time	Method
Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L))	After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

Secondary Outcome Measures

Name	Time	Method
Hypoglycaemic symptoms score	After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
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	After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
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	After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L	After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇹 Graz, Austria