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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00696657

First Posted: June 13, 2008

Last Update Posted: February 27, 2017

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Information provided by (Responsible Party):

Novo Nordisk A/S

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 Intervention Model: Parallel Assignment Masking: Double (Participant, 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:

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 ]

Secondary Outcome Measures:

Percentage of subjects with an adverse events [ Time Frame: after 12 weeks of treatment ]
Percentage of subjects with hypoglycaemic episode [ Time Frame: after 12 weeks of treatment ]
Change from baseline in ECG [ Time Frame: week 0, week 12 ]
Change from baseline in vital signs (Pulse) [ Time Frame: week 0, week 12 ]
Change from baseline in vital signs (blood pressure) [ Time Frame: week 0, week 12 ]
Change from baseline in standard safety laboratory parameters (haematology) [ Time Frame: week 0, week 12 ]
Change from baseline in standard safety laboratory parameters ( biochemistry) [ Time Frame: week 0, week 12 ]
Change from baseline in standard safety laboratory parameters (urinalysis) [ Time Frame: week 0, week 12 ]
Change from baseline in calcitonin [ Time Frame: week 0, week 12 ]
Percentage of subjects developing anti-semaglutide antibodies [ Time Frame: after 12 weeks of treatment ]


Enrollment:	415
Actual Study Start Date:	June 3, 2008
Study Completion Date:	February 5, 2009
Primary Completion Date:	February 5, 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: semaglutide 0.1 mg, once weekly, s.c. injection Other Name: NN9535
Experimental: B	Drug: semaglutide 0.2 mg, once weekly, s.c. injection Other Name: NN9535
Experimental: C	Drug: semaglutide 0.4 mg, once weekly, s.c. injection Other Name: NN9535
Experimental: D	Drug: semaglutide 0.8 mg, once weekly, s.c. injection Other Name: NN9535
Experimental: E	Drug: semaglutide 0.8 mg with titration, once weekly, s.c. injection Other Name: NN9535
Experimental: F	Drug: semaglutide 1.6 mg with titration, once weekly, s.c. injection Other Name: NN9535
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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696657

Show 77 Study Locations

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nauck MA, Petrie JR, Sesti G, Mannucci E, Courrèges 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.


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00696657 History of Changes
Other Study ID Numbers:	NN9535-1821 2007-003956-12 ( EudraCT Number )
First Submitted:	June 11, 2008
First Posted:	June 13, 2008
Last Update Posted:	February 27, 2017
Last Verified:	February 2017

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Liraglutide	Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

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