Efficacy and safety of sitagliptin added to metformin and insulin compared with voglibose in patients with newly diagnosed type 2 diabetes
Clinics
;
74: e736, 2019. tab, graf
Article
in English
| LILACS
| ID: biblio-1001839
ABSTRACT
OBJECTIVE:
To assess the efficacy and safety of sitagliptin compared with voglibose added to combined metformin and insulin in patients with newly diagnosed type 2 diabetes (T2DM).METHODS:
In this 12-week prospective, randomized, parallel trial, 70 newly diagnosed T2DM patients with glycosylated hemoglobin (HbA1c) ≥9% and/or fasting plasma glucose (FPG) ≥11.1 mmol/L were randomized (11) to receive sitagliptin 100 mg per day + metformin + insulin glargine or voglibose 0.2 mg three times daily + metformin + insulin glargine. Change in HbA1c at week 12 was the primary endpoint.RESULTS:
The mean baseline HbA1c was 11.0% in the patients. The changes in HbA1c from baseline were -6.00% in the sitagliptin group and -3.58% in the voglibose group, and the between-group difference was -2.42% (95% CI -1.91 to -2.93, p=0.02). The differences in FPG and homeostatic model assessment of β-cell function (HOMA-β) and the change in body weight between groups from baseline were -2.95 mmol/L (p=0.04), 43.91 (p=0.01) and -2.23 kg (p=0.01), respectively. One patient (2.9%) in the sitagliptin group and three patients (8.6%) in the voglibose group exhibited hypoglycemia.CONCLUSIONS:
Sitagliptin added to combined metformin and insulin therapy showed greater efficacy and good safety regarding hypoglycemia in patients with newly diagnosed T2DM compared with voglibose.
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Diabetes Mellitus, Type 2
/
Sitagliptin Phosphate
/
Hypoglycemic Agents
/
Inositol
/
Metformin
Type of study:
Controlled clinical trial
/
Diagnostic study
/
Observational study
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
Language:
English
Journal:
Clinics
Journal subject:
Medicine
Year:
2019
Type:
Article
Affiliation country:
China
Institution/Affiliation country:
Dalian Medical University/CN
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