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

NCT00377858 | Completed Phase 4 Results

• 2 other identifiers: 10936F3Z-MC-IOOX
• Study Type: interventional
• Target: 484
• Locations: 7 countries
• Sites: 25

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes; type 2

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c) at 36 Week Endpoint

  Level of hemoglobin A1c at endpoint.

  36 weeks

Secondary Outcomes (11)

• Hemoglobin A1c (HbA1c) at Interval Visits

  12, 24, and 36 weeks

• Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint

  12-24-36 weeks

• 7-point Self-monitored Blood Glucose Profiles

  Baseline, 12-24-36 weeks

• Glycemic Variability

  Baseline, 12-24-36 weeks

• Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia

  Baseline to 36 Weeks

Study Arms (2)

Insulin Lispro Mid Mixture

EXPERIMENTAL

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

Drug: Insulin lispro mid mixture (MM)

Insulin Glargine

ACTIVE COMPARATOR

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

Drug: Insulin glargine

Interventions

Insulin lispro mid mixture (MM) DRUG

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

Also known as: Humalog, Mid Mix

Insulin Lispro Mid Mixture

Insulin glargine DRUG

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

Insulin Glargine

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (25)

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, 5035, Australia

Location

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.

Fitzroy, Victoria, 3065, Australia

Location

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Fremantle, Western Australia, 6160, Australia

Location

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London, Ontario, N6A 4L2, Canada

Location

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Granby, Quebec, J2G 1T7, Canada

Location

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Sherbrooke, Quebec, J1G 5K2, Canada

Location

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Regina, Saskatchewan, S4P 0W5, Canada

Location

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Mantes-la-Jolie, 78200, France

Location

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Menton, 06500, France

Location

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Pau, 64000, France

Location

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Poitiers, 86000, France

Location

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Toulouse, 31082, France

Location

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Chihuahua City, 31238, Mexico

Location

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Guadalajara, 44620, Mexico

Location

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Arkhangelsk, 163045, Russia

Location

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.

Moscow, 117036, Russia

Location

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.

Saint Petersburg, 193257, Russia

Location

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Goyang-Si/Kyunggi-Do, 410-719, South Korea

Location

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.

Kwangju, 501-757, South Korea

Location

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Seoul, 110-746, South Korea

Location

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Alicante, 03114, Spain

Location

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Almería, 04001, Spain

Location

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Barcelona, 08017, Spain

Location

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Bilbao, 48013, Spain

Location

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Málaga, 29010, Spain

Location

Related Publications (1)

• 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.

  PMID: 23489710 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Insulin Lispro; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2006
• First Posted: September 19, 2006
• Study Start: August 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 9, 2009
• Results First Posted: December 3, 2009

Record last verified: 2009-12

Locations

RU (3); ES (5); CA (4); KR (3); FR (5); AU (3); ME (2)