Brief Summary

This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.

Trial Health

On Track

Trial Health Score

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

Enrollment

400

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Nov 2006

Typical duration for phase_3 diabetes

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

October 27, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed

2 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

March 12, 2010

Completed

Last Updated

March 8, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

October 27, 2006

Results QC Date

February 23, 2010

Last Update Submit

January 25, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
after 24 weeks of treatment

Secondary Outcomes (12)

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
after 52 weeks of treatment
Fasting Plasma Glucose After 24 Weeks of Treatment
after 24 weeks of treatment
Fasting Plasma Glucose After 52 Weeks of Treatment
after 52 weeks of treatment
Postprandial Glucose AUC After 24 Weeks of Treatment
after 24 weeks of treatment
Postprandial Glucose AUC After 52 Weeks of Treatment
after 52 weeks of treatment
+7 more secondary outcomes

Study Arms (2)

Liraglutide

EXPERIMENTAL

Liraglutide 0.9 mg + glibenclamide placebo

Drug: liraglutideDrug: placebo

Glibenclamide

ACTIVE COMPARATOR

Glibenclamide 1.25-2.5 mg + liraglutide placebo

Drug: glibenclamideDrug: placebo

Interventions

liraglutideDRUG

0.9 mg/day. Injected s.c. (under the skin) once daily.

Liraglutide

glibenclamideDRUG

1.25-2.5 mg tablet. Given orally once or twice daily.

Glibenclamide

placeboDRUG

liraglutide placebo. Injected s.c. (under the skin) once daily.

Glibenclamide

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks
HbA1c greater than or equal to 7.0% and less than 10.0%
BMI (Body Mass Index) less than 35 kg/m2

You may not qualify if:

Treatment with insulin within the last 12 weeks
Treatment with any drug that could interfere with the glucose level
Any serious medical condition
Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Novo Nordisk A/Slead

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Publications (4)

Seino Y, Rasmussen MF, Nishida T, Kaku K. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin. 2010 May;26(5):1013-22. doi: 10.1185/03007991003672551.
PMID: 20199137RESULT
Seino Y, Rasmussen MF, Clauson P, Kaku K. The once-daily human glucagon-like peptide-1 analog, liraglutide, improves beta-cell function in Japanese patients with type 2 diabetes. J Diabetes Investig. 2012 Aug 20;3(4):388-95. doi: 10.1111/j.2040-1124.2012.00193.x.
PMID: 24843595RESULT
Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
PMID: 23010561RESULT
Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.
PMID: 21209033DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

LiraglutideGlyburide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsSulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Results Point of Contact

Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S

Study Officials

Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 27, 2006

First Posted

October 30, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2007

Study Completion

May 1, 2008

Last Updated

March 8, 2017

Results First Posted

March 12, 2010

Record last verified: 2017-01

Locations

JP(1)

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Liraglutide

Glibenclamide

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Liraglutide

Glibenclamide

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations