A Study on the Effect of 2 Pen Devices on HbA1c

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: HumaPen Luxura; Device: HumaPen Memoir; Drug: Insulin Lispro; Drug: Huminsulin Regular

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985712

12704

H9D-SB-ITAE (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function.

Enrollment: 263 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus
• receiving at least 3 prandial injections per day with short-acting or analogue insulin

Exclusion criteria

• Insulin pump therapy
• receiving pre-mixed insulin preparations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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263 participants in 2 patient groups

HumaPen Luxura

Experimental group

Description:

Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks

Treatment:

Device: HumaPen Luxura

Drug: Huminsulin Regular

Drug: Insulin Lispro

HumaPen Memoir

Experimental group

Description:

Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

Treatment:

Drug: Huminsulin Regular

Drug: Insulin Lispro

Device: HumaPen Memoir