Abstract | BACKGROUND: OBJECTIVE: METHODS: In this open-label, 16-week, parallel-group study, patients were randomized to 1 of 2 treatments: glyburide 15 mg/d (or up to the maximum daily dose) or Mix75/25. The Mix75/25 group was randomly subdivided into preprandial (immediately before breakfast and dinner) and postprandial (within 15 minutes after the start of breakfast and dinner) injection subgroups. The primary outcomes were glycemic control and rate of hypoglycemia. RESULTS: A total of 143 patients were randomized; 127 completed the study. The change in glycosylated hemoglobin (HbA(1c)) from baseline to end point was significantly greater with Mix75/25 than with glyburide (mean +/- SEM, -1.14% +/- 0.18% vs -0.36% +/- 0.15%, P = 0.001). HbA(1c) changes with preprandial and postprandial Mix75/25 were not significantly different (-1.20% +/- 0.26% vs -1.08% +/- 0.26%, P = 0.748). Fasting blood glucose (BG), 2-hour postprandial BG, and mean daily BG reductions were greater with Mix75/25 than with glyburide (P < 0.001); preprandial and postprandial Mix75/25 administration did not differ significantly with respect to any of these BG variables. The hypoglycemia rate increased with Mix75/25 by 0.17 +/- 0.02 episodes per patient per 30 days, but there was no change with glyburide (P = 0.077). Body weight increased by 1.02 +/- 0.35 kg with Mix75/25 and decreased by 0.85 +/- 0.18 kg with glyburide (P < 0.001). CONCLUSIONS:
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Authors | Matthias Herz, Bin Sun, Zvonko Milicevic, Pamella Erickson, Jozsef Fövènyi, Marek Grzywa, Terezie Pelikanova |
Journal | Clinical therapeutics
(Clin Ther)
Vol. 24
Issue 1
Pg. 73-86
(Jan 2002)
ISSN: 0149-2918 [Print] United States |
PMID | 11833837
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin
- Insulin Lispro
- Recombinant Proteins
- Glyburide
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Topics |
- Aged
- Aged, 80 and over
- Blood Glucose
(metabolism)
- Body Weight
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Double-Blind Method
- Female
- Follow-Up Studies
- Glyburide
(administration & dosage, adverse effects, therapeutic use)
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemia
(blood, chemically induced)
- Hypoglycemic Agents
(administration & dosage, adverse effects, therapeutic use)
- Insulin
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Insulin Lispro
- Male
- Middle Aged
- Patient Acceptance of Health Care
- Postprandial Period
(physiology)
- Recombinant Proteins
(therapeutic use)
- Treatment Outcome
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