Type 2 diabetes MedDRA version: 14.0 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: NovoMix 30 FlexPen 100 U/ml suspension for injection in a pre-filled pen
Pharmaceutical Form: Suspension for injection in pre-filled pen
INN or Proposed INN: Insulin aspart
CAS Number: 116
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm efficacy of subject-driven titration of biphasic insulin aspart (BIAsp) 30 twice daily in terms of glycaemic control assessed by change in glucosylated haemoglobin (HbA1c). This is done by showing that subject-driven titration of BIAsp 30 is non-inferior to investigator-driven titration of BIAsp 30 with respect to glycaemic control, as measured by HbA1c after 20 weeks of treatment in subjects with type 2 diabetes inadequately controlled on basal insulin analogues.;Secondary Objective: - To assess and compare efficacy in terms of: - Fasting plasma glucose (FPG) values - 7-point Self Measured Plasma Glucose (SMPG) profile - To assess and compare safety and tolerability in terms of: - Hypoglycaemic episodes - Adverse events (AEs) - Clinical and laboratory assessments - Change in body weight - To assess time to plasma glucose (PG) target in terms of: 2-point Self Measured Plasma Glucose (SMPG) profile - To evaluate insulin dose - To assess diabetes treatment satisfaction - To assess healthcare resource utilization;Primary end point(s): Change in HbA1c from baseline to week 20/end of trial;Timepoint(s) of evaluation of this end point: from baseline to week 20/end of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Change in fasting plasma glucose (FPG) (central laboratory values) from baseline to week 20/end of trial 2- Number of hypoglycaemic episodes during the trial 3- Patient Reported Outcomes evaluated at baseline, at week 4 and at week 20/end of trial with: - Treatment-Related Impact Measures for Diabetes (TRIM-D);Timepoint(s) of evaluation of this end point: 1- from baseline to week 20/end of trial - during the trial - at baseline, at week 4 and at week 20/end of trial with: - Treatment-Related Impact Measures for Diabetes (TRIM-D) | — |
Countries
Argentina, China, India, Poland, Spain, Turkey, United Kingdom
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed