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

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ClinicalTrials.gov Identifier: NCT00377858
Recruitment Status : Completed
First Posted : September 19, 2006
Results First Posted : December 3, 2009
Last Update Posted : December 9, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin A1c (HbA1c) at 36 Week Endpoint [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. Hemoglobin A1c (HbA1c) at Interval Visits [ Time Frame: 12, 24, and 36 weeks ]
  2. 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 ]
  3. 7-point Self-monitored Blood Glucose Profiles [ Time Frame: Baseline, 12-24-36 weeks ]
  4. Glycemic Variability [ Time Frame: Baseline, 12-24-36 weeks ]
  5. Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia [ Time Frame: Baseline to 36 Weeks ]
  6. 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) [ Time Frame: Baseline to 36 Weeks ]
  7. Number of Patients With at Least One Severe Hypoglycemia Episode [ Time Frame: Baseline to 36 Weeks ]
  8. Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial [ Time Frame: 36 Weeks ]
  9. Endpoint Insulin Dose; Total, Basal, and Prandial [ Time Frame: 36 Weeks ]
  10. Number of Insulin Injections Per Day [ Time Frame: Weeks 12, 24, 30, 36 ]
  11. Change From Baseline in Absolute Body Weight at 36 Week Endpoint [ Time Frame: Baseline, 36 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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.
Menton, France, 06500
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Pau, France, 64000
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.
Poitiers, France, 86000
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.
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
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.
Seoul, Korea, Republic of, 110-746
Mexico
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.
Chihuahua, Mexico, 31238
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.
Guadalajara, Mexico, 44620
Russian Federation
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.
Arkhangelsk, Russian Federation, 163045
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, Russian Federation, 117036
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, Russian Federation, 193257
Spain
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.
Alicante, Spain, 03114
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.
Almeria, Spain, 04001
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.
Barcelona, Spain, 08017
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.
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

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
First Posted: September 19, 2006    Key Record Dates
Results First Posted: December 3, 2009
Last Update Posted: December 9, 2009
Last Verified: December 2009

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
 Insulin
Insulin Glargine
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs