Bachiller En Ciencias Y Letras

Global results: outcomes of the
A1chieve observational study

Home et al, Diabetes Res Clin Pract, 2011 In Press

A1chieve global results
Presentation structure

• Study design
• Populationcharacteristics
• Global and by pre-study therapy
• Results by allocated insulin type
• Results by regional distribution

A1chieve study overview and design
• Observational study of peoplewith T2DM starting
insulin analogues in routine clinical practice
• Non-interventional
• Insulin chosen by investigator

• Other clinical care and insulins provided as in routine
clinical practiceA1chieve study overview and design
• Observational study of people with T2DM starting
insulin analogues in routine clinical practice

Start a study
insulin
• Biphasic insulin
aspart 30
•Insulin detemir
• Insulin aspart

BASELINE
Week 0

•

INTERIM
Week 12

FINAL
Week 24

Study objectives
•

Primary: number of attributed adverse drug
reactions (includes majorhypoglycaemia)

•

Secondary: other safety and effectiveness
measures

A1chieve: glucose-lowering therapies
before and during the study
1. Insulin naïve
• OGLDs
• No therapy

2. Insulin users
•±OGLDs

Pre-study
therapy

1. Insulin detemir (Levemir) ± OGLDs
2. Biphasic insulin aspart (NovoMix) ±
OGLDs
3. Basal + aspart (NovoRapid) ± OGLDs
4. Insulin aspart (NovoRapid) ± OGLDs
5.Others ± OGLDs
Baseline
therapy

Baseline
0 wk

Interim
therapy

End of trial
therapy

Interim
12 wk

OGLDs, oral glucose-lowering drugs

Final
24 wk

A1chieve global resultsPresentation structure

• Study design
• Population characteristics
• Global and by pre-study therapy
• Results by allocated insulin type
• Results by regional distribution

Audience responsequestion (1)
• In A1chieve, what was the mean diabetes duration at
baseline in people on OGLDs alone vs. insulin ±
OGLDs?

1.

OGLDs
alone
2.6 years vs.

insulin
±OGLDs
4.5 years

2....