Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin 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
  Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.
• placebo — DRUG
  Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Study Details

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.

Key Dates

Start date

Dec 1, 2014

Status verified

May 2019

Primary completion

Nov 21, 2015

Completion

Nov 21, 2015

Study Design

Enrollment

397 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide 0.5 mg/Week
• Experimental: Semaglutide 1.0 mg/Week
• Placebo Comparator: Semaglutide Placebo 0.5 mg/Week
• Placebo Comparator: Semaglutide Placebo 1.0 mg/Week

Primary Outcome Measure

Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 30 ]

Locations (72)

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