Clinical trial NCT00551356: Lispro Mix 25 vs. Glargine in Type 2 Diabetics
Official title: Comparison of the Insulin Therapies: Insulin Lispro Low Mix (25%) and Insulin Glargine in Patients With Diabetes Mellitus Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes
Diabetic
Insulin
Humalog
Lantus
Glargine
Lispro
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-10-31
Enrollment: 53
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.

Detailed description: The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.

Eligibility criteria: Inclusion Criteria:

* Males or females who have type 2 diabetes between 1 and 10 years
* Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
* Have not been on insulin treatment within 3 months before entry into the study
* Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
* Have a body mass index below 40 kg/m²

Exclusion Criteria:

* Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
* Have a known allergy to insulin
* Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
* Have known proliferative retinopathy
* Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study

Primary outcomes:
measure: Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast
timeFrame: 16 weeks or end of study.
Secondary outcomes:
measure: Hemoglobin A1c measured at endpoint
timeFrame: 16 weeks or end of study.
measure: Change of hemoglobin A1c from baseline to endpoint
timeFrame: 16 weeks or end of study.
measure: Glycemic control as determined by self-monitored blood glucose concentrations
timeFrame: 16 weeks or end of study.
measure: The incidence and rate of self-reported hypoglycemic episodes
timeFrame: 16 weeks or end of study.
measure: Body mass index (BMI)
timeFrame: 16 weeks or end of study.
measure: Body weight
timeFrame: 16 weeks or end of study.
measure: Total Insulin Doses
timeFrame: 16 weeks or end of study.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: