Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• semaglutide — DRUG
  Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.
• liraglutide — DRUG
  Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.
• placebo — DRUG
  Administered subcutaneously ( s.c., under the skin) once daily.

Study Details

This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes

Key Dates

Start date

Sep 21, 2015

Status verified

Jul 2019

Primary completion

Oct 13, 2016

Completion

Oct 13, 2016

Study Design

Enrollment

706 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide 0.05 mg/day
• Active Comparator: Liraglutide 0.3 mg/day
• Placebo Comparator: Placebo 50 µL
• Experimental: Semaglutide 0.05/0.1 mg/day
• Active Comparator: Liraglutide 0.3/0.6 mg/day
• Placebo Comparator: Placebo 50/100 µL
• Experimental: Semaglutide 0.05/0.1/0.2 mg/day
• Active Comparator: Liraglutide 0.3/0.6/1.2 mg/day
• Placebo Comparator: Placebo 50/100/200 µL
• Experimental: Semaglutide 0.05/0.1/0.2/0.3 mg/day
• Active Comparator: Liraglutide 0.3/0.6/1.2/1.8 mg/day
• Placebo Comparator: Placebo 50/100/200/300 µL
• Experimental: Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day

Primary Outcome Measure

Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]

Locations (84)

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