Type 2 Diabetes
Conditions
Keywords
Diabetes, Diabetic, Insulin, Glargine, Lispro
Brief summary
The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.
Detailed description
The primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.
Interventions
DRUGLispro mix 75/25
Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
DRUGGlargine
SC injection, once-daily, given in conjunction with oral antidiabetic medications.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Have type 2 diabetes * Have inadequate overall glycemic control (hemoglobin A1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to Visit 1 * Have used: * single or multiple OAMs for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or * insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or * a combination of the above. * Are greater than or equal to 21 and less than 80 years of age * As determined by the investigator, are capable and willing to: * comply with their prescribed diet and medication regimen, * perform self blood glucose monitoring, * use the patient diary as required for this protocol, * participate in two 24 hour inpatient assessments
Exclusion criteria
* Have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study * Are currently treated with a meglitinide without sulfonylurea * Have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin * Have plasma creatinine greater than or equal to 1.5 mg/dL (for males) or greater than or equal to 1.4 mg/dL (for females) for patients who will be treated with metformin or; greater than 2 mg/dL for patients treated with other OAMs, as determined by a local laboratory * Have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period. | At end of treatment arm or 3 months. |
Secondary
| Measure | Time frame |
|---|---|
| 2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined | At end of treatment arm or 3 months. |
| Plasma glucose AUC excursions during a 24 hours when plasma glucose exceeds the following: greater than or equal to 7.5 mmol/L (135 mg/dL), greater than or equal to 7.8 mmol/L (140 mg/dL), and greater than or equal to 10.0 mmol/L (180 mg/dL) | At end of treatment arm or 3 months. |
| The number of patients with increased plasma glucose during the last 2 hours of each inpatient period | At end of treatment arm or 3 months. |
| HbA1c | At end of treatment arm or 3 months. |
| Concentration of plasma triglycerides and free fatty acids | At end of treatment arm or 3 months. |
| Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value | At end of treatment arm or 3 months. |
| Insulin dose and body weight | At end of treatment arm or 3 months. |
| The mean amplitude of glycemic excursion | At end of treatment arm or 3 months. |
Countries
United States
Outcome results
None listed