A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) in subjects with type 2 diabetes mellitus using two different titration algorithms

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 18.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-004625-25-CZ
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-27
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

1. Type 2 diabetes mellitus
2. Male or female =18 years of age
3. HbA1c 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
4. Stable daily treatment with metformin (=1500 mg or max tolerated dose) ± pioglitazone (=30 mg) for at least 90 days prior to screening
5. Body Mass Index (BMI) =40 kg/m^2
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 278
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 138

Exclusion Criteria

1. Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
2. Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
3. Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
4. Impaired liver function, defined as alanine aminotransferase (ALAT) =2.5 times upper normal range (UNR)
5. Impaired renal function defined as serum-creatinine =133 µmol/L ( =1.5 mg/dL) for males and =125 µmol/L ( =1.4 mg/dL) for females, or as defined according to local contraindications for metformin
6. Screening calcitonin =50 ng/L
7. Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
9. History of pancreatitis (acute or chronic)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified