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To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together

NCT ID: NCT00318461

Last Updated: 2017-03-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1091 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-11-30

Brief Summary

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This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

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Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes

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The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

NCT01618162

Diabetes Diabetes Mellitus, Type 2
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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

Study Groups

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Lira 0.6 + Met

Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

0.6 mg for s.c. (under the skin) injection.

metformin

Intervention Type DRUG

1.5-2.0 g tablets

placebo

Intervention Type DRUG

Glimepiride placebo 1 mg and 2 mg tablets

Lira 1.2 + Met

Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

1.5-2.0 g tablets

placebo

Intervention Type DRUG

Glimepiride placebo 1 mg and 2 mg tablets

liraglutide

Intervention Type DRUG

1.2 mg for s.c. (under the skin) injection

Lira 1.8 + Met

Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

1.5-2.0 g tablets

placebo

Intervention Type DRUG

Glimepiride placebo 1 mg and 2 mg tablets

liraglutide

Intervention Type DRUG

1.8 mg for s.c. (under the skin) injection

Met Mono

Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

1.5-2.0 g tablets

placebo

Intervention Type DRUG

Glimepiride placebo 1 mg and 2 mg tablets

placebo

Intervention Type DRUG

Liraglutide placebo 1-3 mL for s.c. (under the skin) injection

Met + Glim

Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

1.5-2.0 g tablets

glimepiride

Intervention Type DRUG

4 mg tablets

placebo

Intervention Type DRUG

Liraglutide placebo 1-3 mL for s.c. (under the skin) injection

Interventions

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liraglutide

0.6 mg for s.c. (under the skin) injection.

Intervention Type DRUG

metformin

1.5-2.0 g tablets

Intervention Type DRUG

glimepiride

4 mg tablets

Intervention Type DRUG

placebo

Glimepiride placebo 1 mg and 2 mg tablets

Intervention Type DRUG

placebo

Liraglutide placebo 1-3 mL for s.c. (under the skin) injection

Intervention Type DRUG

liraglutide

1.2 mg for s.c. (under the skin) injection

Intervention Type DRUG

liraglutide

1.8 mg for s.c. (under the skin) injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
* HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
* Body Mass Index (BMI) less than or equal 40 kg/m2

Exclusion Criteria

* Subjects treated with insulin within the last three months
* Subjects with any serious medical condition
* Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
* Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Bensheim, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Darmstadt, , Germany

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Diez, , Germany

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Dormagen, , Germany

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Dresden, , Germany

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Ciudad Autonoma de Bs As, , Argentina

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Ciudad Autónoma de Bs As, , Argentina

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Ciudad Autónoma de BsAs, , Argentina

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Junín, , Argentina

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Broadmeadow, New South Wales, Australia

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Penrith, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Daw Park, South Australia, Australia

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East Ringwood, Victoria, Australia

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Fremantle, Western Australia, Australia

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Adelaide, , Australia

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Adelaide, , Australia

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Auckland, , Australia

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Bankstown, , Australia

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Box Hill, , Australia

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Cairns, , Australia

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Camperdown, , Australia

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Christchurch, , Australia

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Clayton, , Australia

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Fitzroy, , Australia

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Garran, , Australia

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Hornsby, , Australia

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Malvern, , Australia

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Perth, , Australia

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Westmead, , Australia

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Woodville, , Australia

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Arlon, , Belgium

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Bonheiden, , Belgium

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Ghent, , Belgium

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Huy, , Belgium

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La Louvière, , Belgium

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Leuven, , Belgium

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Sofia, , Bulgaria

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Zagreb, , Croatia

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Aalborg, , Denmark

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Århus C, , Denmark

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Copenhagen, , Denmark

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Frederiksberg, , Denmark

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Herlev, , Denmark

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Hjørring, , Denmark

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Hvidovre, , Denmark

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København S, , Denmark

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Odense, , Denmark

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Viborg, , Denmark

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Aschaffenburg, , Germany

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Bad Heilbrunn, , Germany

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Bad Kreuznach, , Germany

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Bad Lauterberg im Harz, , Germany

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Bad Mergentheim, , Germany

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Bad Neuenahr-Ahrweiler, , Germany

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Großheirath, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Kutenholz-Mulsum, , Germany

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Marburg, , Germany

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Münster, , Germany

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Neuwied, , Germany

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Oberhausen, , Germany

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Pirna, , Germany

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Pohlheim, , Germany

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Rehlingen-Siersburg, , Germany

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Saarbrücken, , Germany

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Speyer, , Germany

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Stuttgart, , Germany

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Sulzbach-Rosenberg, , Germany

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Budapest, , Hungary

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Gyula, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Szekszárd, , Hungary

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Hyderabad, Andhra Pradesh, India

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Dublin, , Ireland

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Waterford, , Ireland

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Bari, , Italy

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Catania, , Italy

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Florence, , Italy

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Milan, , Italy

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Sassari, , Italy

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Verona, , Italy

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Apeldoorn, , Netherlands

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Groningen, , Netherlands

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Rotterdam, , Netherlands

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Sliedrecht, , Netherlands

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Bekkestua, , Norway

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Bergen, , Norway

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Elverum, , Norway

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Gjøvik, , Norway

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Hamar, , Norway

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Kongsberg, , Norway

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Kongsvinger, , Norway

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Stavanger, , Norway

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Trondheim, , Norway

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Cluj-Napoca, Cluj, Romania

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Constanța, , Romania

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Iași, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Moldava nad Bodvou, , Slovakia

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Prešov, , Slovakia

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Trenčín, , Slovakia

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Durban, KwaZulu-Natal, South Africa

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Cape Town, Western Cape, South Africa

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Benoni, , South Africa

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A Coruña, , Spain

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Alcázar de San Juan, , Spain

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Almería, , Spain

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Barcelona, , Spain

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Bilbao, , Spain

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Cadiz, , Spain

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Girona, , Spain

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Granada, , Spain

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Málaga, , Spain

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Mérida, , Spain

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San Cristóbal de La Laguna, , Spain

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San Juan, , Spain

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Santa Cruz de Tenerife, , Spain

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Santander, , Spain

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Seville, , Spain

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Falun, , Sweden

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Karlstad, , Sweden

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Linköping, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Abergavenny, , United Kingdom

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Bath, , United Kingdom

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Bath, , United Kingdom

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Berkshire, , United Kingdom

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Cardiff, , United Kingdom

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Coventry, , United Kingdom

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Dundee, , United Kingdom

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East Horsley, , United Kingdom

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Frome, , United Kingdom

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Llanelli, , United Kingdom

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Oxford, , United Kingdom

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Plymouth, , United Kingdom

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Sheffield, , United Kingdom

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Sunbury-on-Thames, , United Kingdom

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Countries

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Argentina Australia Belgium Bulgaria Croatia Denmark Germany Hungary India Ireland Italy Netherlands Norway Romania Russia Slovakia South Africa Spain Sweden United Kingdom

References

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Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.

Reference Type RESULT
PMID: 18931095 (View on PubMed)

Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

Reference Type RESULT
PMID: 19245711 (View on PubMed)

Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997.

Reference Type RESULT
PMID: 19491535 (View on PubMed)

McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.

Reference Type RESULT
PMID: 19491536 (View on PubMed)

Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x.

Reference Type RESULT
PMID: 19878259 (View on PubMed)

Jendle J, Nauck MA, Matthews DR, Frid A, Hermansen K, During M, Zdravkovic M, Strauss BJ, Garber AJ; LEAD-2 and LEAD-3 Study Groups. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009 Dec;11(12):1163-72. doi: 10.1111/j.1463-1326.2009.01158.x.

Reference Type RESULT
PMID: 19930006 (View on PubMed)

Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

Reference Type RESULT
PMID: 21450987 (View on PubMed)

Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

Reference Type RESULT
PMID: 22055210 (View on PubMed)

Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.

Reference Type RESULT
PMID: 22193143 (View on PubMed)

Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

Reference Type RESULT
PMID: 21883806 (View on PubMed)

Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x.

Reference Type RESULT
PMID: 21883438 (View on PubMed)

Nauck M, Frid A, Hermansen K, Thomsen AB, During M, Shah N, Tankova T, Mitha I, Matthews DR. Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. Diabetes Obes Metab. 2013 Mar;15(3):204-12. doi: 10.1111/dom.12012. Epub 2012 Oct 11.

Reference Type RESULT
PMID: 22985213 (View on PubMed)

Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

Reference Type RESULT
PMID: 22862847 (View on PubMed)

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.

Reference Type RESULT
PMID: 23010561 (View on PubMed)

King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

Reference Type RESULT
PMID: 23186975 (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)

Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.

Reference Type DERIVED
PMID: 24561125 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21209033 (View on PubMed)

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN2211-1572

Identifier Type: -

Identifier Source: org_study_id

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