Trial Information

Summary: A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine.

Status: Completed

Protocol Number: RD000000275

Sponsor: Disetronic Medical Systems AG

Company Division: Diagnostic

Official Scientific Title: Comparison between CSII with multiple basal Lispro infusion rates and MDI with Lispro and Glargine.

Brief Summary: This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin Lispro with that obtained by multiple daily injections of insulin Lispro and Glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.

Study Phase: N/A

Study Design / Study Details:

• Purpose:
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Crossover
• Endpoints: Efficacy

Study Type:

Condition: Diabetes Mellitus, Type 1

Intervention Type: Device

Intervention Name:

Primary Outcome:

Key Secondary Outcomes:

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 60 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2003

Trial Registration Date: 04/23/2007

Date Last Updated: 04/26/2007

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:35:49 PM