A 20 weeks randomised, multinational, open labelled,2 parallel group comparison of biphasic insulin aspart (BIAsp) 30 in combination with metformin in subjects with type 2 diabetes, which is inadequately controlled on basal insulin analogues. One treatment group use twice daily titration of biphasic insulin aspart 30 driven by the subject, the other group use twice daily titration of biphasic insulin aspart 30 driven by the investigator. Both groups combine their treatment with metformin.

• Conditions: Type 2 diabetes; MedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.0Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2010-024303-27-GB
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-26
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

- Male or female, age =18
- Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1
- Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1
- Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg
metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The
metformin treatment must have been stable for at least 2 months prior to Visit 1
- HbA1c = 7.0% and =10.0%. (One re-test within one week of screening visit is allowed. The last
sample will be conclusive.)
- Body Mass Index (BMI) = 40.0 kg/m2
- Able and willing to eat at least 2 main meals each day during the trial
- Able and willing to adhere to the protocol including compliance with performance of self
measured plasma glucose (SMPG), injection regimen and titrating themselves according to the
protocol
- Experience in performing self measured plasma glucose (SMPG)
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

- Treatment with any thiazolidinedione (TZD) and Glucagon-like peptide-1 (GLP-1) receptor
agonists or pramlintide within the last 3 months prior to Visit 1
- Impaired hepatic function defined as alanine aminotransferase (ALAT)= 2.5 times upper
referenced limit. (One re-test within one week of screening visit is allowed. The last sample will
be conclusive.)
- Impaired kidney function with serum creatinine = 133 µmol/L (1.5 mg/dL) for males and = 124
µmol/L (1.4 mg/dL) for females. (One re-test within one week of screening visit is allowed. The
last sample will be conclusive.)
- Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic
blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg)
- Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human
preparations) or bolus insulin. Previous use of pre-mixed or bolus insulin products is allowed only in case of hospitalisation or a severe condition requiring intermittent use of premixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (Visit 1)

Study & Design

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