Completed

Semaglutide and Liraglutide Dose Evaluation in Type 2 Diabetes Patients on Metformin or Diet Control

Study Aim

This study aims to evaluate the optimal dose of Semaglutide and Liraglutide in treating Type 2 Diabetes patients who are currently on Metformin or diet control, by observing changes in HbA1c levels over a 12-week period.

What is being tested

semaglutide

+ placebo

+ liraglutide

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: June 2008

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 3, 2008

Actual date on which the first participant was enrolled.

This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

Official TitleInvestigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial

NCT00696657

Principal SponsorNovo Nordisk A/S

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

415 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate

Body weight between 60 kg and 110 kg

Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months

Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months

HbA1c: 7.0-10.0 % (both inclusive)

6 exclusion criteria prevent from participating

Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months

Impaired liver or kidney function

Proliferative retinopathy or maculopathy requiring acute treatment

Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

14 intervention groups are designated in this study

42.857% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Experimental

Group 6

Experimental

Group 7

Placebo

Group 8

Placebo

Group 9

Placebo

Group 10

Placebo

Group 11

Placebo

Group 12

Placebo

Group 13

Experimental

Group 14

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 77 locations

Suspended

Novo Nordisk Investigational Site

Gratwein, AustriaOpen Novo Nordisk Investigational Site in Google Maps

Suspended

Novo Nordisk Investigational Site

Graz, Austria

Suspended

Novo Nordisk Investigational Site

Innsbruck, Austria

Suspended

Novo Nordisk Investigational Site

Mödling, Austria

Completed77 Study Centers