Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: biphasic insulin aspart 30Subject-driven group (Experimental
: Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use will be given to
Sponsors
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1 (screening) Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1 (screening) 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 (screening) HbA1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit is allowed. The last sample will be conclusive) Body Mass Index (BMI) below or equal to 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)
Exclusion criteria
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 (screening) Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to 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 above or equal to 133 µmol/L (1.5 mg/dL) for males and above or equal to 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 higher or equal to 180 mmHg and/or diastolic blood pressure higher or equal to 100 mmHg) Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (glycosylated haemoglobin)Timepoint: Time frame: Week 0, week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting plasma glucose (FPG) (central laboratory values). Timepoint: Time frame: Week 0, week 20;Number of hypoglycaemic episodes. Timepoint: Time frame: from week 0 to week 20 ;Patient Reported Outcomes evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D). Timepoint: Time frame: Weeks 0, 4 and 20 | — |
Countries
Argentina, China, India, Poland, Turkey, United Kingdom
Contacts
Public ContactMr Avik Kumar Gosh
Novo Nordisk India Private Ltd.
Outcome results
None listed