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Clinical Trials/EUCTR2011-001493-25-AT
EUCTR2011-001493-25-ATActive, not recruitingNot Applicable

A trial comparing the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec, both in combination with metformin, in subjects with type 2 diabetes qualifying for treatment intensification - BEGIN™: VICTOZA® ADD-O

ovo Nordisk A/S0 sites420 target enrollmentStarted: June 9, 2011Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
420
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- The subject must have completed the end of treatment visit of NN1250-3643 with IDeg OD + metformin.
  • •- Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 300
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

  • •- Participated in NN1250-3643 and treated with IGlar + metformin +/- DPP-IV inhibitor or IDeg + metformin + DPP-IV inhibitor
  • •- Previous treatment with glucacon like peptide 1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
  • •- Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times the upper limit of normal at end of treatment in NN1250-3643
  • •- Impaired renal function defined as serum-creatinine = 125 µmol/L (= 1.4 mg/dL) for males and = 110 µmol/L (= 1.3 mg/dL) for females, at end of treatment in NN1250-3643

Investigators

Similar Trials

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Not Applicable
A trial, in which subjects with type 2 diabetes, who qualify for treatment intensification, are given insulin degludec and, additionally, either liraglutide or insulin aspart, both in combination with metformin, with the largest meal. The purpose is to compare efficacy and safety of these two treatments.Type 2 diabetesMedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2011-001493-25-DEovo Nordisk A/S420
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A trial, in which subjects with type 2 diabetes, who qualify for treatment intensification, are given insulin degludec and, additionally, either liraglutide or insulin aspart, both in combination with metformin, with the largest meal. The purpose is to compare efficacy and safety of these two treatments.Diabetes tipo 2MedDRA version: 13.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2011-001493-25-ESovo Nordisk A/S420
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A trial, in which subjects with type 2 diabetes, who qualify for treatment intensification, are given insulin degludec and, additionally, either liraglutide or insulin aspart, both in combination with metformin, with the largest meal. The purpose is to compare efficacy and safety of these two treatments.
EUCTR2011-001493-25-DKovo Nordisk A/S420
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A trial, in which subjects with type 2 diabetes, who qualify for treatment intensification, are given insulin degludec and, additionally, either liraglutide or insulin aspart, both in combination with metformin, with the largest meal. The purpose is to compare efficacy and safety of these two treatments.Type 2 diabetesMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2011-001493-25-BEovo Nordisk A/S420
Active, not recruiting
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A trial, in which subjects with type 2 diabetes, who qualify for treatment intensification, are given insulin degludec and, additionally, either liraglutide or insulin aspart, both in combination with metformin, with the largest meal. The purpose is to compare efficacy and safety of these two treatments.Type 2 diabetesMedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2011-001493-25-CZovo Nordisk A/S420