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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. Hemoglobin A1c (HbA1c) at Interval Visits [ Time Frame: 12, 24, and 36 weeks ]
    Levels of HbA1c at 12 weeks and 24 weeks 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 ]
    Actual daily mean blood glucose levels at specified time points.

  4. Glycemic Variability [ Time Frame: Baseline, 12-24-36 weeks ]
    Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.

  5. Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia [ Time Frame: Baseline to 36 Weeks ]
    Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.

  6. 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) [ Time Frame: Baseline to 36 Weeks ]
    Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.

  7. Number of Patients With at Least One Severe Hypoglycemia Episode [ Time Frame: Baseline to 36 Weeks ]
    Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.

  8. Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial [ Time Frame: 36 Weeks ]
    Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.

  9. Endpoint Insulin Dose; Total, Basal, and Prandial [ Time Frame: 36 Weeks ]
    Total daily insulin dose (Units of insulin per day [U/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.

  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 ]
    Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
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

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
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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
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Malaga, Spain, 29010
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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):
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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00377858    
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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs