Background and aims: MEDIAS2 BOT+SIT+CT (More Diabetes Selfmanagement for People with type 2 diabetes on a Basal insulin supported Oral Therapy or on Supplementary Insulin Treatment with prandial insulin or Conventional Insulin Treatment with biphasic insulin) is a newly developed diabetes education and treatment programme for people with type 2 diabetes(PWD-T2) on a non-intensive insulin treatment regimen. The development of MEDIAS2 BOT+SIT+CT was based on self-management and empowerment theory. The efficacy of the newly developed intervention MEDIAS 2 BOT+SIT+CT (IG) was evaluated in a randomized trial with a six month follow-up period. The control group (CG) participated in an established education programme (Treatment- and education programme for type 2 diabetic patients with injection of prandial and/or basal insulin). The primary outcome of this study was the reduction of HbA1c. Materials and methods: Both interventions in IG and CG consisted of 6 lessons. At baseline and follow-up the HbA1c was measured in a central laboratory. Participants also completed questionnaires to measure diabetes distress, empowerment, diabetes knowledge and hypoglycaemia awareness. Results: 186 PWD-T2 participated in the study (IG vs. CG: age 63.0 ±8.4 vs. 63.2 ±7.6 yrs.; diabetes duration 11.5 ±5.7 vs. 11.4 ±7.0 yrs.; duration of insulin treatment 3.6 ±4.0 vs. 3.6 ±4.5 yrs.; HbA1c 8.0 ±1.3 vs. 7.9 ±1.2 %; respectively 63.9 ± 14.2 mmol/mol vs. 62.8 ± 13.1 mmol/mol; hypoglycaemia-unawareness score 2.0 ±1.0 vs. 2.1 ±0.9). There were no significant differences at baseline between IG and CG. HbA1c was significantly more reduced in IG compared to CG (-0.7 ±0.1 vs. -0.3 ±0.1 percentage Points, respectively -7.7 ±1.1 mmol/mol vs. 4.4 ±1.1 mmol/mol; p=.02). Hypoglycaemia awareness did not deteriorate in both groups (1.9 ±0.1 vs. 2.1 ±0.1 p=.276). Diabetes distress and empowerment improved in both groups, but there were no significant between group differences. Conclusion: Participation in the newly developed MEDIAS2 BOT+SIT+CT treatment and education programme led to a significant improvement of glycaemic control without a measurable increase in risk for hypoglycaemia. An important component of the newly developed MEDIAS2 BOT+SIT+CT was self-titration of insulin doses; this might have contributed to the positive impact of this programme on glycaemic control. In summary, MEDIAS2 BOT+SIT+CT has been proven as an effective treatment and education tool.