Clinical trial NCT02147431: A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L))
timeFrame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Secondary outcomes:
measure: 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
timeFrame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
measure: 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
timeFrame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
measure: Hypoglycaemic symptoms score
timeFrame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
measure: Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L
timeFrame: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Korsatko S, Jensen L, Brunner M, Sach-Friedl S, Tarp MD, Holst AG, Heller SR, Pieber TR. Effect of once-weekly semaglutide on the counterregulatory response to hypoglycaemia in people with type 2 diabetes: A randomized, placebo-controlled, double-blind, crossover trial. Diabetes Obes Metab. 2018 Nov;20(11):2565-2573. doi: 10.1111/dom.13422. Epub 2018 Jul 16.