Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: In this 24-week, multicenter, parallel-group, randomized, treat-to-target study, 321 Chinese insulin-naïve subjects with poorly controlled type 2 diabetes (fasting blood glucose >or=7.8 mmol/l and A1C >or=7.5%) were randomized (1:1) to twice- or thrice-daily (BID and TID groups, respectively) BIAsp 30 without OADs. Initial insulin doses were based on fasting blood glucose at randomization. Insulin dose was adjusted with algorithm-controlled titration to achieve premeal blood glucose of 4.4-6.1 mmol/l. RESULTS: A1C decreased significantly in both groups (BID group -2.48 +/- 0.07%; TID group -2.81 +/- 0.07%). Thrice-daily BIAsp 30 showed superiority in A1C improvement (-0.33% [95% CI -0.53 to -0.13]; P < 0.01) and helped more subjects achieve A1C targets <7% (BID group 51.3% vs. TID group 65.8%; P < 0.01). Thrice-daily BIAsp 30 was more effective in subjects with baseline A1C >or=9% (<7%: BID group 41.5% vs. TID group 58.3%; P < 0.01). There was no significant difference in rates of overall and nocturnal major and minor hypoglycemia per subject year between groups. No significant differences in weight gain (BID group 3.87 +/- 0.28 kg; TID group 4.09 +/- 0.27 kg) and mean daily insulin doses (BID group 0.82 +/- 0.28 units/kg; TID group 0.86 +/- 0.34 units/kg) were observed. CONCLUSIONS:
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Authors | Wenying Yang, Qiuhe Ji, Dalong Zhu, Jinkui Yang, Lulu Chen, Zhimin Liu, Demin Yu, Li Yan |
Journal | Diabetes care
(Diabetes Care)
Vol. 31
Issue 5
Pg. 852-6
(May 2008)
ISSN: 1935-5548 [Electronic] United States |
PMID | 18268073
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biphasic Insulins
- Blood Glucose
- Hypoglycemic Agents
- Insulin
- insulin aspart, insulin aspart protamine drug combination 30:70
- Insulin, Isophane
- Insulin Aspart
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Topics |
- Administration, Oral
- Adolescent
- Adult
- Biphasic Insulins
- Blood Glucose
(metabolism)
- Blood Glucose Self-Monitoring
- Body Mass Index
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Drug Administration Schedule
- Drug Therapy, Combination
- Female
- Humans
- Hypoglycemia
(epidemiology)
- Hypoglycemic Agents
(administration & dosage, adverse effects, therapeutic use)
- Insulin
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Insulin Aspart
- Insulin, Isophane
- Male
- Middle Aged
- Safety
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