Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve 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 (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
• insulin glargine — DRUG
  Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.

Study Details

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

Key Dates

Start date

Aug 4, 2014

Status verified

May 2019

Primary completion

Sep 3, 2015

Completion

Sep 3, 2015

Study Design

Enrollment

1,089 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide 0.5 mg/week
• Experimental: Semaglutide 1.0 mg/week
• Active Comparator: Insulin glargine

Primary Outcome Measure

Change in HbA1c From Baseline [ Time Frame: Week 0, week 30 ]

Locations (136)

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