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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00377858
First received: September 11, 2006
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin lispro mid mixture (MM)
Drug: Insulin glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Hemoglobin A1c (HbA1c) at 36 Week Endpoint [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin A1c (HbA1c) at Interval Visits [ Time Frame: 12, 24, and 36 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 12-24-36 weeks ] [ Designated as safety issue: No ]
  • 7-point Self-monitored Blood Glucose Profiles [ Time Frame: Baseline, 12-24-36 weeks ] [ Designated as safety issue: No ]
  • Glycemic Variability [ Time Frame: Baseline, 12-24-36 weeks ] [ Designated as safety issue: No ]
  • Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia [ Time Frame: Baseline to 36 Weeks ] [ Designated as safety issue: Yes ]
  • 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) [ Time Frame: Baseline to 36 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients With at Least One Severe Hypoglycemia Episode [ Time Frame: Baseline to 36 Weeks ] [ Designated as safety issue: Yes ]
  • Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]
  • Endpoint Insulin Dose; Total, Basal, and Prandial [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]
  • Number of Insulin Injections Per Day [ Time Frame: Weeks 12, 24, 30, 36 ] [ Designated as safety issue: No ]
  • Change From Baseline in Absolute Body Weight at 36 Week Endpoint [ Time Frame: Baseline, 36 Weeks ] [ Designated as safety issue: No ]

Enrollment: 484
Study Start Date: August 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin Lispro Mid Mixture
Insulin lispro mid mixture (MM) up to three times a day (TID)
Drug: Insulin lispro mid mixture (MM)
Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
Other Names:
  • Humalog
  • Mid Mix
Active Comparator: Insulin Glargine
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
Drug: Insulin glargine
Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377858

Locations
Australia, South Australia
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, 5035
Australia, Victoria
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Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
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Fremantle, Western Australia, Australia, 6160
Canada, Ontario
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London, Ontario, Canada, N6A 4L2
Canada, Quebec
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Granby, Quebec, Canada, J2G 1T7
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Sherbrooke, Quebec, Canada, J1G 5K2
Canada, Saskatchewan
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Regina, Saskatchewan, Canada, S4P 0W5
France
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Mantes La Jolie, France, 78200
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Menton, France, 06500
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Pau, France, 64000
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Poitiers, France, 86000
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Toulouse, France, 31082
Korea, Republic of
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Goyang-Si/Kyunggi-Do, Korea, Republic of, 410-719
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Kwang Ju, Korea, Republic of, 501-757
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Seoul, Korea, Republic of, 110-746
Mexico
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Chihuahua, Mexico, 31238
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Guadalajara, Mexico, 44620
Russian Federation
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Arkhangelsk, Russian Federation, 163045
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Moscow, Russian Federation, 117036
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Saint Petersburg, Russian Federation, 193257
Spain
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Alicante, Spain, 03114
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Almeria, Spain, 04001
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Barcelona, Spain, 08017
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Bilbao, Spain, 48013
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.
Malaga, Spain, 29010
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00377858     History of Changes
Other Study ID Numbers: 10936, F3Z-MC-IOOX
Study First Received: September 11, 2006
Results First Received: September 16, 2009
Last Updated: December 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Eli Lilly and Company:
diabetes
type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin Lispro
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014