Clinical Development

Researcher Investigator Initiated studies, for type 1	2009	2009	2013
Phase & Country	Phase II, USA and Canada	Phase II, Sweden	Phase II, Sweden
Aim	Intervention	Prevention	Combination, intervention
Participants	Type 1 diabetes patients	Children at high risk	Type 1 diabetes patients
Age, years	3-45	>4	10-18
Number of patients	N=145	N=50	N=60
Trial period	Trial period: 12 months Follow-up: 12 months Completed	Trial period: 3 years Follow-up: 2 years Ongoing	Trial period: 6 months Follow-up: 24 months Ongoing, recruiting
Purpose	Safety and efficacy	Safety and efficacy	Safety and efficacy

Diamyd® for type 1	2004	2008	2008
Phase & Country	Phase IIb, Sweden	Phase III, Europe	Phase III, USA
Participants	Type 1 diabetes patients	Type 1 diabetes patients	Type 1 diabetes patients
Age, years	10-18	10-20	10-20
Number of patients	N=70	N=320	N=320
Trial period	Trial period: 15 months Follow-up: 15 months Completed	Trial period: 15 months Follow-up: 15 months Closed	Trial period: 15 months Follow-up: 15 months Closed
Purpose	Safety and efficacy	Safety and efficacy	Safety and efficacy

Diamyd® for LADA	2000	2004
Phase & Country	Phase IIa, Sweden	Phase IIb, Sweden
Participants	LADA patients	LADA patients
Age, years	30-70	30-70
Number of patients	N=47	N=160
Trial period	Trial period: 6 months Follow-up: 5 years Completed	Trial period: 18 months Follow-up: 12 months Completed
Purpose	Dose-finding, safety and efficacy	Safety

Diamyd® Drug Substance	1995	1999
Phase & Country	Skin prick test, Sweden	Phase I, UK
Participants	Type 1 diabetes patients and healthy individuals	Healthy individuals
Age, years	Adolescents	24-45
Number of patients	N=15	N=24
Trial period	28 days	10 weeks
Purpose	Safety	Safety and tolerability