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

A study of patients with type 2 diabetes who are not controlled 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.

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

Conditions

Type 2 Diabetes

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Hemoglobin A1c at endpoint (36 weeks)

Secondary Outcome Measures:

• 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

Study Start

August 2006; Expected completion: April 2008

Eligibility & Criteria

• Ages Eligible for Study: 30 Years – 80 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• Have type 2 diabetes
• Have been receiving oral antihyperglycemic medications 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

Total Enrolment

502

Contact Details

Australian Locations:

• Miranda, New South Wales, 2228, Australia; Recruiting
• Keswick, South Australia, 5035, Australia; Recruiting
• Fitzroy, Victoria, 3065, Australia; Recruiting
• Fremantle, Western Australia, 6160, Australia; Recruiting

For more information, refer to Lilly Clinical Trial Registry