A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: semaglutide Drug: placebo Drug: liraglutide	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

HbA1c [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects with an adverse events [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
Percentage of subjects with hypoglycaemic episode [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
Change from baseline in ECG [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
Change from baseline in vital signs (Pulse) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
Change from baseline in vital signs (blood pressure) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
Change from baseline in standard safety laboratory parameters (haematology) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
Change from baseline in standard safety laboratory parameters ( biochemistry) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
Change from baseline in standard safety laboratory parameters (urinalysis) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
Change from baseline in calcitonin [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
Percentage of subjects developing anti-semaglutide antibodies [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]


Enrollment:	415
Study Start Date:	June 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: semaglutide 0.1 mg, once weekly, s.c. injection
Experimental: B	Drug: semaglutide 0.2 mg, once weekly, s.c. injection
Experimental: C	Drug: semaglutide 0.4 mg, once weekly, s.c. injection
Experimental: D	Drug: semaglutide 0.8 mg, once weekly, s.c. injection
Experimental: E	Drug: semaglutide 0.8 mg with titration, once weekly, s.c. injection
Experimental: F	Drug: semaglutide 1.6 mg with titration, once weekly, s.c. injection
Placebo Comparator: G1	Drug: placebo 0.1 mg, once weekly, s.c. injection
Placebo Comparator: G2	Drug: placebo 0.2 mg, once weekly, s.c. injection
Placebo Comparator: G3	Drug: placebo 0.4 mg, once weekly, s.c. injection
Placebo Comparator: G4	Drug: placebo 0.8 mg with titration, once weekly, s.c. injection
Placebo Comparator: G5	Drug: placebo 0.8 mg with titration, once weekly, s.c. injection
Placebo Comparator: G6	Drug: placebo 1.6 mg, once weekly, s.c. injection
Experimental: H	Drug: liraglutide 1.2 mg with titration, once daily, s.c. injection
Experimental: I	Drug: liraglutide 1.8 mg with titration, once daily, s.c. injection

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696657

Locations


Bulgaria

Russe, Bulgaria, 7000
Finland

Turku, Finland, FI-20520
Former Serbia and Montenegro

Belgrade, Former Serbia and Montenegro, 11000
France

MONTPELLIER cedex 5, France, 34295
Germany

Pohlheim, Germany, 35415
Hungary

Budapest, Hungary, 1041
India

Chennai, Tamil Nadu, India, 600086
Italy

Chieti Scalo, Italy, 66100
Spain

Almería, Spain, 04001
Switzerland

Genève 14, Switzerland, 1211
Turkey

Istanbul, Turkey, 34390
United Kingdom

Bexhill-on-Sea, United Kingdom, TN39 4SP

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Christine B. Jensen, MD, PhD	Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00696657 History of Changes
Other Study ID Numbers:	NN9535-1821, 2007-003956-12
Study First Received:	June 11, 2008
Last Updated:	October 30, 2013
Health Authority:	Austria: Federal Ministry for Health and Women Bulgaria: Bulgarian Drug Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy India: Ministry of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Serbia: Medicines and Medical Devices Agency of Serbia South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Switzerland: Laws and standards Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Glucagon-Like Peptide 1 Liraglutide	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Incretins Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015