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

Sponsor
Novo Nordisk A/S
Study ID
NCT02147431
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 21, 2014
Status verified
Aug 2018
Primary completion
May 20, 2015
Completion
May 20, 2015

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

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) ]

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