Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus (PUMP)
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|ClinicalTrials.gov Identifier: NCT00607087|
Recruitment Status : Completed
First Posted : February 5, 2008
Results First Posted : July 30, 2010
Last Update Posted : August 31, 2010
|Study Design||Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment|
Diabetes Mellitus, Type 1
Drug: Insulin glulisine
Drug: Insulin lispro
Drug: Insulin aspart
|Recruitment Details||Multicenter study: 44 active centers from 12 countries in Europe, USA and Asia Pacific region. Study Initiation date: January 8, 2008, Study Completion Date: June 15, 2009.|
359 participants screened; 289 randomized; 288 patients treated (1 patient not treated per physician's decision): 274 with insulin glulisine, 269 with insulin lispro, 266 with insulin aspart.
The safety population, (N=288 patients randomized and treated) is described in the participant flow and baseline characteristics.