Catalyst

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Tresiba demonstrates significantly lower rate of hypoglycaemia than insulin glargine in blinded phase 3b trial in people with type 2 diabetes; headline results of SWITCH 1 expected later in the first quarter of 2016

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Additional Information

Clinical Data
Primary Outcome Measures:
  • Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period [ Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of treatment emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic during the maintenance period [ Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) ] [ Designated as safety issue: No ]
  • Proportion of subjects with one or more severe hypoglycaemic episodes during the maintenance period [ Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events [ Time Frame: During 32 weeks of treatment for each treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 32, Week 64 ] [ Designated as safety issue: No ]
  • FPG (fasting plasma glucose) [ Time Frame: Week 32, Week 64 ] [ Designated as safety issue: No ]
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Catalyst Date
Occurred on:
Jan 29, 2016
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Related Keywords Hypoglycaemia, Insulin Glargine, Blinded Phase 3b Trial, Type 2 Diabetes, Insulin Degludec, Iglar, Ideg