Clinical trial NCT00696657: A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: HbA1c
timeFrame: After 12 weeks of treatment.
Secondary outcomes:
measure: Percentage of Subjects With an Adverse Events
timeFrame: After 12 weeks of treatment.
measure: Percentage of Subjects With Hypoglycaemic Episode
timeFrame: After 12 weeks of treatment
measure: Change From Baseline in ECG
timeFrame: Week 0, week 12.
measure: Change From Baseline in Vital Signs (Pulse)
timeFrame: Week 0, week 12
measure: Change From Baseline in Vital Signs (Blood Pressure; SBP)
timeFrame: Week 0, week 12
measure: Change From Baseline in Vital Signs (Blood Pressure; DBP)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)
timeFrame: Week 0, week 12.
measure: Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
timeFrame: Week 0, week 12
measure: Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
timeFrame: Week 0, week 12
measure: Change From Baseline in Calcitonin
timeFrame: Week 0, week 12.
measure: Percentage of Subjects Developing Anti-semaglutide Antibodies
timeFrame: After 12 weeks of treatment
Other outcomes:
Locations:
city: Gratwein
country: Austria
facility: Novo Nordisk Investigational Site
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Innsbruck
country: Austria
facility: Novo Nordisk Investigational Site
city: Mödling
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Plovdiv
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Russe
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Varna
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Imatra
country: Finland
facility: Novo Nordisk Investigational Site
city: Mikkeli
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Tampere
country: Finland
facility: Novo Nordisk Investigational Site
city: Turku
country: Finland
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Former Serbia and Montenegro
facility: Novo Nordisk Investigational Site
city: Dommartin Les Toul
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: MONTPELLIER cedex 5
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Bad Lauterberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Falkensee
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: Marburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Pohlheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Gyula
country: Hungary
facility: Novo Nordisk Investigational Site
city: Pecs
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szekszárd
country: Hungary
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
city: Catanzaro
country: Italy
facility: Novo Nordisk Investigational Site
city: Chieti
country: Italy
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano (MI)
country: Italy
facility: Novo Nordisk Investigational Site
city: Napoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Perugia
country: Italy
facility: Novo Nordisk Investigational Site
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: Gijón
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Bern
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Genève 14
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Lausanne
country: Switzerland
facility: Novo Nordisk Investigational Site
city: St. Gallen
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Antalya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Addlestone
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bexhill-on-Sea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bradford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Guildford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hull
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Inverness
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Llanelli
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Trowbridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry B. (GCR, 1452), MD, PhD
role: STUDY_DIRECTOR
References:
citation: Nauck MA, Petrie JR, Sesti G, Mannucci E, Courreges JP, Lindegaard ML, Jensen CB, Atkin SL; Study 1821 Investigators. A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):231-41. doi: 10.2337/dc15-0165. Epub 2015 Sep 10.