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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147431
• Other study ID #: NN9535-3684
• Secondary ID: 2013-002751-15U1
• Status: Completed
• Phase: Phase 1
• Start date: May 21, 2014
• Est. completion date: May 20, 2015

Study information

• Verified date: August 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 20, 2015
• Est. primary completion date: May 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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, c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Hypoglycaemic symptoms score		After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
Secondary	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)

External Links

•   Clinical Trials at Novo Nordisk