Abstract | OBJECTIVE: BACKGROUND:
Insulin lispro Mix75/25 (Mix75/25) is the first available insulin formulation in which both the rapid-acting and basal components are insulin analogues. METHODS: This randomized, multicenter, double-blind, crossover study monitored patients' postprandial glucodynamic response to Mix75/25 and human insulin 70/30 (70/30) after a standard test meal. Eighty-four patients with type 2 diabetes participated in this study and were randomly assigned to 1 of 2 treatment sequence groups. Patients received an identical test meal on 4 occasions, completing 2 test meals for each treatment. Equal doses of Mix75/25 or 70/30 were administered 5 minutes before each of the 2 test meals, with doses individualized for each patient. Blood samples were collected for 4 hours after the meal for measurement of plasma glucose. From these plasma glucose measurements, fasting plasma glucose, 2-hour postprandial glucose (2pp), 2-hour postprandial glucose excursion (2pp(ex)), maximum glucose excursion (Gex(max)), the area under the glucose concentration versus time curve from 0 to 4 hours (AUC4), and the area under the glucose excursion versus time curve from 0 to 4 hours (AUCex4) were calculated. RESULTS: Because of significant differences in the baseline fasting plasma glucose levels between Mix75/25 and 70/30 (Mix75/25: 8.9+/-2.2 mmol/L [160.2+/-39.6 mg/dL]; 70/30: 8.6+/-1.9 mmol/L [154+/-34 mg/dL), analyses of the excursion parameters provide a truer comparison of the glucodynamic response between insulin formulations. Mix75/25 resulted in significantly lower values for 2pp(ex) (3.35+/-2.28 vs 4.13+/-2.26 mmol/L), Gex(max) (4.51+/-1.88 vs 5.19+/-1.98 mmol/L), and AUCex4 (8.01+/-7.02 vs 10.6+/-6.47 mmol x h/L) compared with 70/30. CONCLUSIONS:
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Authors | J K Malone, J R Woodworth, V Arora, H Yang, B N Campaigne, J P Hallé, J F Yale, L D Grossman |
Journal | Clinical therapeutics
(Clin Ther)
Vol. 22
Issue 2
Pg. 222-30
(Feb 2000)
ISSN: 0149-2918 [Print] United States |
PMID | 10743981
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Blood Glucose
- Hypoglycemic Agents
- Insulin
- Insulin Lispro
- Protamines
- neutral protamine lispro insulin
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Topics |
- Adult
- Aged
- Area Under Curve
- Blood Glucose
(drug effects)
- Cross-Sectional Studies
- Diabetes Mellitus, Type 2
(drug therapy)
- Double-Blind Method
- Female
- Humans
- Hypoglycemic Agents
(administration & dosage, pharmacokinetics, therapeutic use)
- Injections, Intravenous
- Insulin
(administration & dosage, analogs & derivatives, pharmacokinetics, therapeutic use)
- Insulin Lispro
- Male
- Middle Aged
- Postprandial Period
- Protamines
(administration & dosage, pharmacokinetics, therapeutic use)
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