Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: There were 284 NIDDM patients (20-82 years of age) whose glycemic control while on a diet was judged stable but was judged unsatisfactory (fasting plasma glucose [FPG] > or = 8.3 mmol/l) when entered into a multicenter and double-blind study with parallel groups study. They were randomly allocated into two groups, the troglitazone group (the T group: 400 mg/day p.o.) and the placebo group (the P group), and were treated with test drugs for 12 weeks. RESULTS: We evaluated efficacy in 136 patients of the T group and 126 patients of the P group. There was no significant difference in any of baseline characteristics between the T and P groups. In the T group, FPG and HbA1c decreased significantly after treatment (before versus after, FPG 10.1 +/- 1.6 vs. 8.8 +/- 1.9 mmol/l, P < 0.001; HbA1c: 8.6 +/- 1.5 vs 8.1 +/- 1.7%, P < 0.001). FPG and HbA1c did not change after treatment in the P group (before versus after, FPG 10.1 +/- 1.8 vs. 9.9 +/- 2.1 mmol/l; HbA1c 8.5 +/- 1.5 vs. 8.6 +/- 1.6%). Of 136 patients in the T group, 62 (45.6%) were classified as responders. Serum triglyceride level also decreased in the T group but not in the P group. Body weight increased slightly only in the T group. There were no differences in changes in blood pressure between the two groups. No serious adverse events occurred in either group. CONCLUSIONS:
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Authors | Y Iwamoto, K Kosaka, T Kuzuya, Y Akanuma, Y Shigeta, T Kaneko |
Journal | Diabetes care
(Diabetes Care)
Vol. 19
Issue 2
Pg. 151-6
(Feb 1996)
ISSN: 0149-5992 [Print] United States |
PMID | 8718436
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Chromans
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Placebos
- Thiazoles
- Thiazolidinediones
- Triglycerides
- Cholesterol
- Troglitazone
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Blood Pressure
- Body Weight
- Cholesterol
(blood)
- Chromans
(adverse effects, therapeutic use)
- Diabetes Mellitus, Type 2
(blood, diet therapy, drug therapy)
- Diet, Diabetic
- Double-Blind Method
- Female
- Glycated Hemoglobin
(analysis)
- Humans
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Placebos
- Thiazoles
(adverse effects, therapeutic use)
- Thiazolidinediones
- Triglycerides
(blood)
- Troglitazone
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