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

NCT ID: NCT00154401

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-10-31

Brief Summary

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This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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liraglutide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy
* Diet treated subjects: 7.5% \< HbA1c \< 10%
* Single oral drug therapy subjects: 7.0% \< HbA1c \< 9.5%
* Body Mass Index (BMI): max 40 kg/m\^2

Exclusion Criteria

* Subjects treated with thiazolidinediones or insulin
* Subjects with any serious medical conditions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Aalborg, , Denmark

Site Status

Novo Nordisk Investigational Site

Århus C, , Denmark

Site Status

Novo Nordisk Investigational Site

Copenhagen, , Denmark

Site Status

Novo Nordisk Investigational Site

Hellerup, , Denmark

Site Status

Novo Nordisk Investigational Site

Hvidovre, , Denmark

Site Status

Novo Nordisk Investigational Site

Kolding, , Denmark

Site Status

Novo Nordisk Investigational Site

København S, , Denmark

Site Status

Novo Nordisk Investigational Site

Køge, , Denmark

Site Status

Novo Nordisk Investigational Site

Antibes, , France

Site Status

Novo Nordisk Investigational Site

Dax, , France

Site Status

Novo Nordisk Investigational Site

La Rochelle, , France

Site Status

Novo Nordisk Investigational Site

Marseille, , France

Site Status

Novo Nordisk Investigational Site

Montpellier, , France

Site Status

Novo Nordisk Investigational Site

Mougins, , France

Site Status

Novo Nordisk Investigational Site

Narbonne, , France

Site Status

Novo Nordisk Investigational Site

Nevers, , France

Site Status

Novo Nordisk Investigational Site

Nîmes, , France

Site Status

Novo Nordisk Investigational Site

Pessac, , France

Site Status

Novo Nordisk Investigational Site

Rennes, , France

Site Status

Novo Nordisk Investigational Site

Vénissieux, , France

Site Status

Novo Nordisk Investigational Site

's-Hertogenbosch, , Netherlands

Site Status

Novo Nordisk Investigational Site

Amsterdam, , Netherlands

Site Status

Novo Nordisk Investigational Site

Apeldoorn, , Netherlands

Site Status

Novo Nordisk Investigational Site

Groningen, , Netherlands

Site Status

Novo Nordisk Investigational Site

Hengelo, , Netherlands

Site Status

Novo Nordisk Investigational Site

Sliedrecht, , Netherlands

Site Status

Novo Nordisk Investigational Site

The Hague, , Netherlands

Site Status

Novo Nordisk Investigational Site

Banská Bystrica, , Slovakia

Site Status

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Site Status

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Site Status

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Site Status

Novo Nordisk Investigational Site

Bratislava, , Slovakia

Site Status

Novo Nordisk Investigational Site

Košice, , Slovakia

Site Status

Novo Nordisk Investigational Site

Košice, , Slovakia

Site Status

Novo Nordisk Investigational Site

Košice, , Slovakia

Site Status

Novo Nordisk Investigational Site

Lučenec, , Slovakia

Site Status

Novo Nordisk Investigational Site

Prešov, , Slovakia

Site Status

Novo Nordisk Investigational Site

Šahy, , Slovakia

Site Status

Novo Nordisk Investigational Site

Žilina, , Slovakia

Site Status

Countries

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Denmark France Netherlands Slovakia

References

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Vilsboll T, Brock B, Perrild H, Levin K, Lervang HH, Kolendorf K, Krarup T, Schmitz O, Zdravkovic M, Le-Thi T, Madsbad S. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus. Diabet Med. 2008 Feb;25(2):152-6. doi: 10.1111/j.1464-5491.2007.02333.x. Epub 2008 Jan 14.

Reference Type RESULT
PMID: 18201212 (View on PubMed)

Courreges JP, Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Verhoeven R, Buganova I, Madsbad S. Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes. Diabet Med. 2008 Sep;25(9):1129-31. doi: 10.1111/j.1464-5491.2008.02484.x. No abstract available.

Reference Type RESULT
PMID: 19183322 (View on PubMed)

Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courreges JP, Verhoeven R, Buganova I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007 Jun;30(6):1608-10. doi: 10.2337/dc06-2593. Epub 2007 Mar 19. No abstract available.

Reference Type RESULT
PMID: 17372153 (View on PubMed)

Horowitz M, Vilsboll T, Zdravkovic M, Hammer M, Madsbad S. Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide. Diabetes Obes Metab. 2008 Jul;10(7):593-6. doi: 10.1111/j.1463-1326.2008.00861.x. Epub 2008 Apr 22. No abstract available.

Reference Type RESULT
PMID: 18435773 (View on PubMed)

Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.

Reference Type RESULT
PMID: 25504028 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN2211-1571

Identifier Type: -

Identifier Source: org_study_id

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