EUCTR2011-001493-25-ES
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes tipo 2
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 420
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
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 ?mol/L (? 1\.4 mg/dL) for males and ? 110 ?mol/L (? 1\.3 mg/dL) for females, at end of treatment in NN1250\-3643
Outcomes
Primary Outcomes
Not specified
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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
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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-CZovo Nordisk A/S420