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

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

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Australia, South Australia | |
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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 | |
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Malaga, Spain, 29010 |
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 |
Additional Information:
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 |