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The Switch Study: Albiglutide vs Lispro in T2DM
NCT02229227Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2014
- Primary completion
- Jul 2017
- Countries
- 14
- Sponsor
- GSK
- Modality
- Fc-Fusion Proteins
- Drugs
- albiglutide
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, open-label trial of albiglutide in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by GSK. Primary endpoint: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 weeks. Started Nov 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Albiglutide + Insulin Glargine
Albiglutide 30mg (uptitrated to 50mg) + Insulin Glargine. Insulin Lispro discontinued at Week 4.
Insulin Glargine + Insulin Lispro
Continued basal-bolus insulin regimen.
03
Who it enrols
Adults with T2DM, HbA1c 7.0-9.0%, on basal-bolus insulin for >=3 months, BMI <=40 kg/m^2. Excludes severe renal/liver disease, recent CV events, and use of other non-insulin antidiabetics (except metformin).
04
Endpoints
Primary
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Secondary
Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro
Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia
Change From Baseline in Body Weight
Total Daily Insulin Dose
Change From Baseline in Fasting Plasma Glucose (FPG)
05
Results
Primary endpoints met
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