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Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)

NCT ID: NCT00377858

Last Updated: 2009-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-09-30

Brief Summary

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A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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diabetes 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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Insulin Lispro Mid Mixture

Insulin lispro mid mixture (MM) up to three times a day (TID)

Group Type EXPERIMENTAL

Insulin lispro mid mixture (MM)

Intervention Type DRUG

Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks

Insulin Glargine

Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Group Type ACTIVE_COMPARATOR

Insulin glargine

Intervention Type DRUG

Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks

Interventions

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Insulin lispro mid mixture (MM)

Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks

Intervention Type DRUG

Insulin glargine

Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks

Intervention Type DRUG

Other Intervention Names

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Humalog Mid Mix

Eligibility Criteria

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Inclusion Criteria

* Have type 2 diabetes
* Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
* Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.

Exclusion Criteria

* Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
* Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
* Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
* Have a body mass index greater than 40 kg/m2.
* Have had more than one episode of severe hypoglycemia in the last24 weeks
* Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
* Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 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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Eli Lilly

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.

Keswick, South Australia, Australia

Site Status

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Fitzroy, Victoria, Australia

Site Status

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Fremantle, Western Australia, Australia

Site Status

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London, Ontario, Canada

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Granby, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Regina, Saskatchewan, Canada

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Mantes-la-Jolie, , France

Site Status

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Menton, , France

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Pau, , France

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Poitiers, , France

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Toulouse, , France

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Chihuahua City, , Mexico

Site Status

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Guadalajara, , Mexico

Site Status

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Arkhangelsk, , Russia

Site Status

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Moscow, , Russia

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Saint Petersburg, , Russia

Site Status

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Goyang-Si/Kyunggi-Do, , South Korea

Site Status

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Kwangju, , South Korea

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Seoul, , South Korea

Site Status

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Alicante, , Spain

Site Status

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Almería, , Spain

Site Status

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Barcelona, , Spain

Site Status

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Bilbao, , Spain

Site Status

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Málaga, , Spain

Site Status

Countries

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Greece India Australia Canada France Mexico Russia South Korea Spain

References

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Hayes RP, Curtis B, Ilag L, Nelson DR, Wong M, Funnell M. Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy. J Diabetes. 2013 Sep;5(3):358-67. doi: 10.1111/1753-0407.12037. Epub 2013 May 28.

Reference Type DERIVED
PMID: 23489710 (View on PubMed)

Other Identifiers

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F3Z-MC-IOOX

Identifier Type: -

Identifier Source: secondary_id

10936

Identifier Type: -

Identifier Source: org_study_id