Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients

Recruitment & Eligibility

Inclusion Criteria

Diagnosed with type 2 diabetes for a minimum of 12 months prior to screening
Currently treated with a NPH insulin for at least 3 months prior to 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 screening
HbA1c between 7.0% and 10.0% (both inclusive). (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/m^2
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

Treatment with any thiazolidinedione (TZD) and Glucagon-like peptide-1 (GLP-1) receptor agonists or pramlintide within the last 3 months prior to 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 above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Known proliferative retinopathy or maculopathy requiring treatment

Study & Design

Arm && Interventions

Group	Intervention	Description
Subject-driven titration	biphasic insulin aspart 30	-
Investigator-driven titration	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline	Week 0, week 20	Change in HbA1c (%) from baseline to the end of the treatment period.

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline	Week 0, week 20	Change in FPG (laboratory values) from baseline to the end of the treatment period
Number of Hypoglycaemic Episodes During the Trial From Baseline	Week 20	The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L \[50 mg/dL\] or plasma glucose level 3.1 mmol/L \[56 mg/dL\]) during the trial.
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)	Week 0, week 20	Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0-100 scale with higher scores indicating a better health state.
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden	Week 0, week 20	Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included a subscale score -treatment burden. The scores were transformed to a 0-100 scale with higher scores indicating a better health state.

Recruitment & Eligibility