Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.
Interventions
DRUGHumalog Mix 50
DRUGHuman Insulin Mix 50:50
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women who have had either type 1 or type 2 diabetes (World Health Organization\[WHO\]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent. 2. Have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study. 3. Have an HbA1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at Visit 1. 4. Have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring. 5. Have given informed consent to participate in this study in accordance with local regulations.
Exclusion criteria
{1\] Have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study. \[2\] Receive a total daily dose of insulin \>2 units/kg. \[3\] Have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study. \[4\] Have a body mass index \>35 kg/m2. \[5\] Have serum creatinine \> the upper limit of normal (ULN), as determined by a local laboratory.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess hemoglobin A1c (HbA1c) values at baseline and after treatment with insulin lispro mix 50/50. | — |
| Assess HbA1c values at baseline and after treatment with human insulin mix 50/50. | — |
| The secondary objectives of the study are: | — |
| Effects on HbA1c values obtained at the end of each treatment period; | — |
| Effects on fasting blood glucose values obtained throughout the study; | — |
| To compare human insulin mix 50/50 with insulin lispro mix 50/50 with regard to | — |
Countries
China
Outcome results
None listed