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Clinical Trials/EUCTR2011-001493-25-AT
EUCTR2011-001493-25-AT
Active, not recruiting
Not 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 enrollmentJune 9, 2011
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DrugsVictozaNovoRapid

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ovo Nordisk A/S
Enrollment
420
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 9, 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
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 disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2011-001493-25-DEovo Nordisk A/S420
Active, not recruiting
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.Diabetes tipo 2MedDRA version: 13.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2011-001493-25-ESovo Nordisk A/S420
Active, not recruiting
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.
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 disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2011-001493-25-BEovo Nordisk A/S420
Active, not recruiting
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: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2011-001493-25-CZovo Nordisk A/S420