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Clinical Trials/EUCTR2008-002199-88-GB
EUCTR2008-002199-88-GB
Active, not recruiting
Phase 1

Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes A 56 week randomised, double-blind, placebo-controlled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period - SCALE™ - Diabetes

ovo Nordisk A/S0 sites0 target enrollmentStarted: November 5, 2008Last updated:
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ConditionsObesity and overweightMedDRA version: 14.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders
DrugsVictoza®

Overview

Phase
Phase 1
Status
Active, not recruiting
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •Informed consent obtained
  • •Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, SU, glitazone as single agent therapy or any combination of the previously mentioned compounds (metformin\+SU, metformin\+glitazone, SU\+glitazone, metformin\+SU\+glitazone)
  • •HbA1c 7\.0\-10\.0% (both inclusive)
  • •Body Mass Index (BMI) \= 27\.0 kg/m2
  • •Stable body weight
  • •Preceding failed dietary effort
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •Treatment with glucagon\-like peptide\-1 (GLP\-1\) receptor agonists, dipeptidyl peptidase\-4 (DPP\-4\) inhibitors or insulin within the last 3 months
  • •Known proliferative retinopathy or maculopathy
  • •History of acute or chronic pancreatitis
  • •Obesity induced by drug treatment
  • •Use of approved weight lowering pharmacotherapy
  • •Previous surgical treatment of obesity
  • •History of major depressive disorder or suicide attempt
  • •Uncontrolled hypertension (systolic blood pressure \= 160 mmHg and/or diastolic blood pressure \= 100 mmHg)
  • •Screening calcitonin \= 50 ng/L
  • •Familial or personal history of multiple endocrine neoplasia type 2 (MEN2\) or familial medullary thyroid carcinoma (FMTC)

Investigators

Similar Trials

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Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetesA 56 week randomised, double-blind, placebocontrolled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period - SCALE™ - DiabetesObesity and overweightMedDRA version: 14.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders
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