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

September 11, 2006
December 4, 2009
August 2006
September 2008   (final data collection date for primary outcome measure)
Hemoglobin A1c (HbA1c) at 36 Week Endpoint [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Hemoglobin A1c at endpoint (36 weeks)
Complete list of historical versions of study NCT00377858 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hemoglobin A1c at interval visits
  • the percentage of patients who achieved Hemoglobin A1c less than or equal to 6.5%, less than 7% and less than or equal to 7% at interval visits and endpoint
  • the 7-point self-monitored blood glucose profiles
  • insulin doses
  • number of injections per day
  • safety, as measured by incidence and rate of self-reported hypoglycemic episodes, incidence of severe hypoglycemia, weight change, and treatment emergent adverse events
Not Provided
Not Provided
 
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • Drug: Insulin glargine
    Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
  • Experimental: Insulin Lispro Mid Mixture
    Insulin lispro mid mixture (MM) up to three times a day (TID)
    Intervention: Drug: Insulin lispro mid mixture (MM)
  • Active Comparator: Insulin Glargine
    Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
    Intervention: Drug: Insulin glargine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
484
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   France,   Korea, Republic of,   Mexico,   Russian Federation,   Spain
 
NCT00377858
10936, F3Z-MC-IOOX
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP