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Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast

NCT ID: NCT00664534

Last Updated: 2011-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-11-30

Brief Summary

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This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glargine

Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)

Group Type ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type DRUG

patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks

Premixed Insulin Lispro

Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs

Group Type EXPERIMENTAL

Insulin Lispro Premix (mid-mixture and low-mixture)

Intervention Type DRUG

patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks

Interventions

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Insulin Glargine

patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks

Intervention Type DRUG

Insulin Lispro Premix (mid-mixture and low-mixture)

patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks

Intervention Type DRUG

Other Intervention Names

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LY275585

Eligibility Criteria

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Inclusion Criteria

* Diabetes Mellitus, Type 2
* have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione \[TZD\]) without insulin, for at least 90 days prior to Visit 1
* glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
* regularly consume a light breakfast (less than 15% of total daily calorie intake)
* capable and willing to follow the protocol
* give written consent

* have a body mass index greater than 40 kg/m\^2
* have a history of severe hypoglycemia in past 24 weeks
* are pregnant or may become pregnant
* women who are breastfeeding
* have significant cardiac disease
* have significant renal or liver disease
* undergoing therapy for a malignancy
* contraindications to study medications
* have an irregular sleep/wake cycle

Exclusion Criteria

* are taking a TZD whose country label does not allow in combination with insulin
Minimum Eligible Age

30 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Smiths Falls, Ontario, Canada

Site Status

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Alexandria, , Egypt

Site Status

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Bāb al Lūq, , Egypt

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Cairo, , Egypt

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Heliopolis, , Egypt

Site Status

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Ahmedabad, , India

Site Status

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Hyderabaad, , India

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Indore, , India

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Mumbai, , India

Site Status

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Coatzacoalcos, , Mexico

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Mexico City, , Mexico

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Aveiro, , Portugal

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Barreiro, , Portugal

Site Status

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Lisbon, , Portugal

Site Status

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Porto, , Portugal

Site Status

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Bucharest, , Romania

Site Status

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Craiova, , Romania

Site Status

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Galati, , Romania

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Iași, , Romania

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Alicante, , Spain

Site Status

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Badalona, , Spain

Site Status

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Madrid, , Spain

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Palma de Mallorca, , Spain

Site Status

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Santa Cruz de Tenerife, , Spain

Site Status

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Ankara, , Turkey (Türkiye)

Site Status

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Antalya, , Turkey (Türkiye)

Site Status

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Konya, , Turkey (Türkiye)

Site Status

Countries

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Brazil Saudi Arabia Canada Egypt India Mexico Portugal Romania Spain Turkey (Türkiye)

Other Identifiers

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F3Z-EW-S020

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2009/091/000609

Identifier Type: REGISTRY

Identifier Source: secondary_id

11806

Identifier Type: -

Identifier Source: org_study_id