NCT00696657|CompletedPhase 2Results

A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

Investigation 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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN9535-18212007-003956-12

Study Type

interventional

Target

415

Locations

14 countries

Sites

Timeline

RegisteredJun 2008

StartedJun 2008

CompletionFeb 2009

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

415

participants targeted

Target at P75+ for phase_2 diabetes

Timeline

Completed

Started Jun 2008

Shorter than P25 for phase_2 diabetes

Geographic Reach

14 countries

Last participant's last visit for all outcomes

February 5, 2009

Completed

9.6 years until next milestone

Results Posted

Study results publicly available

September 12, 2018

Completed

Last Updated

August 14, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

June 11, 2008

Results QC Date

December 14, 2017

Last Update Submit

August 1, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c
Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.
After 12 weeks of treatment.

Secondary Outcomes (34)

Percentage of Subjects With an Adverse Events
After 12 weeks of treatment.
Percentage of Subjects With Hypoglycaemic Episode
After 12 weeks of treatment
Change From Baseline in ECG
Week 0, week 12.
Change From Baseline in Vital Signs (Pulse)
Week 0, week 12
Change From Baseline in Vital Signs (Blood Pressure; SBP)
Week 0, week 12
+29 more secondary outcomes

0.1 mg, once weekly, s.c. injection

Also known as: NN9535

placeboDRUG

0.1 mg, once weekly, s.c. injection

liraglutideDRUG

1.2 mg with titration, once daily, s.c. injection

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)
Body weight between 60 kg and 110 kg

You may not qualify if:

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
Recurrent major hypoglycaemia or hypoglycaemic unawareness
Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)

Contact the study team to confirm eligibility.