A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

Conditions

Type 1 diabetes mellitus

Brief summary

Change from baseline to Month 24 in C-peptide AUC mean 0-120 min during a 2-hour MMTT, Change from baseline to Month 24 in HbA1c

Detailed description

Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) [evaluated from continuous glucose monitoring (CGM) data] between baseline and Month 24, Number of episodes per patient of severe hypoglycemia between baseline and Month 24, Number of episodes per patient of DKA between baseline and Month 24, Incidence of treatment-emergent adverse events (TEAEs), Incidence of injection site reactions, Physical examination findings, Vital signs (blood pressure [BP], heart rate [HR], and temperature), Clinical laboratory results (chemistry, hematology, and urine), Proportion of patients with a stimulated 90 min C-peptide level above 0.2 nmol/L (0.6 ng/ml) at Month 24, Proportion of patients with HbA1c <7 % (53 mmol/ mol) at Month 24, Change from baseline to Month 24 in exogenous insulin requirements based on total number of units of insulin per kilogram body weight per day, Change in number of severe hypoglycemic <3.0 mmol/L (<54 mg/dL) episodes per day [evaluated from CGM data] between baseline and Month 24

Related papers

No related papers found yet.

Interventions

DRUGDivisun 2000 IE tabletter

DRUGDiamyd

DRUGAlhydrogel®

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline to Month 24 in C-peptide AUC mean 0-120 min during a 2-hour MMTT, Change from baseline to Month 24 in HbA1c	—

Secondary

Measure	Time frame
Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) [evaluated from continuous glucose monitoring (CGM) data] between baseline and Month 24, Number of episodes per patient of severe hypoglycemia between baseline and Month 24, Number of episodes per patient of DKA between baseline and Month 24, Incidence of treatment-emergent adverse events (TEAEs), Incidence of injection site reactions, Physical examination findings, Vital signs (blood pressure [BP], heart rate [HR], and temperature), Clinical laboratory results (chemistry, hematology, and urine), Proportion of patients with a stimulated 90 min C-peptide level above 0.2 nmol/L (0.6 ng/ml) at Month 24, Proportion of patients with HbA1c <7 % (53 mmol/ mol) at Month 24, Change from baseline to Month 24 in exogenous insulin requirements based on total number of units of insulin per kilogram body weight per day, Change in number of severe hypoglycemic <3.0 mmol/L (<54 mg/dL) episodes per day [evaluated from CGM data]	—

Measure

Time frame

Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) [evaluated from continuous glucose monitoring (CGM) data] between baseline and Month 24, Number of episodes per patient of severe hypoglycemia between baseline and Month 24, Number of episodes per patient of DKA between baseline and Month 24, Incidence of treatment-emergent adverse events (TEAEs), Incidence of injection site reactions, Physical examination findings, Vital signs (blood pressure [BP], heart rate [HR], and temperature), Clinical laboratory results (chemistry, hematology, and urine), Proportion of patients with a stimulated 90 min C-peptide level above 0.2 nmol/L (0.6 ng/ml) at Month 24, Proportion of patients with HbA1c <7 % (53 mmol/ mol) at Month 24, Change from baseline to Month 24 in exogenous insulin requirements based on total number of units of insulin per kilogram body weight per day, Change in number of severe hypoglycemic <3.0 mmol/L (<54 mg/dL) episodes per day [evaluated from CGM data]

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Countries

Czechia, Estonia, Germany, Hungary, Netherlands, Poland, Spain, Sweden

Outcome results

None listed