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Trial · Interventional

CompletedPhase 2Registry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
177 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
4 countries

Denmark, France, Netherlands, Slovakia

Start
Jan 2005
Primary completion
Oct 2005
Completion
Oct 2005
First posted
12 Sept 2005 (estimated)
Last update posted
25 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006
  1. Ph 2

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

    NCT00154401

    Jan 2005 to Oct 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. HbA1c

    Time frame · after 14 weeks treatment

Secondary outcomes(3)
  1. Body weight after 14 weeks.

  2. Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.

  3. Safety and tolerability

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

8 results

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.

Vilsbøll et al. 2008Diabetic medicine : a journal of the British Diabetic Associationcited by 167

PMID 18201212DOI 10.1111/j.1464-5491.2007.02333.xPUB-18201212

Full text at the publisher8 results

More studies

4 studies on this page

Indexing hint: Meta-analysis (pooled) · 2015

Corrected

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.

Jensen et al. 2015Diabetes carecited by 45

PMID 25504028DOI 10.2337/dc13-1210PUB-25504028

Rights unknown

Indexing hint: Randomized controlled trial · 2008

Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide.

Horowitz et al. 2008Diabetes, obesity & metabolismcited by 21

PMID 18435773DOI 10.1111/j.1463-1326.2008.00861.xPUB-18435773

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2008

Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes.

Courrèges et al. 2008Diabetic medicine : a journal of the British Diabetic Associationcited by 139

PMID 19183322PMC2592347DOI 10.1111/j.1464-5491.2008.02484.xPUB-19183322

CC BY
Download PDF

Indexing hint: Randomized controlled trial · 2007

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.

Vilsbøll et al. 2007Diabetes carecited by 335

PMID 17372153DOI 10.2337/dc06-2593PUB-17372153

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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