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The COMPLETE T1D Trial: COMParison of Insulin Lispro Protamine Suspension and DETEmir in Type 1 Diabetes Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemi...

Update Il y a 4 ans
Reference: EUCTR2006-006375-21

The COMPLETE T1D Trial: COMParison of Insulin Lispro Protamine Suspension and DETEmir in Type 1 Diabetes Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients with Type 1 Diabetes

Woman and Man

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Extract

The primary objective of this study is to test the hypothesis that basal analog insulin lispro protamine suspension injected two times a day is noninferior to basal analog insulin detemir injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro injected three times a day. The noninferiority margin is 0.4%.

Inclusion criteria

  • Type 1 Diabetes

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