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Efficacy and safety of sitagliptin added to metformin and insulin compared with voglibose in patients with newly diagnosed type 2 diabetes
Shi, Chunhong; Zhang, Ru; Bai, Ran; Liu, Dan; Wang, Yongbo; Zhang, Xueyang; Wang, Hao; Du, Jianling.
  • Shi, Chunhong; Dalian Medical University. First Affiliated Hospital. Department of Endocrinology. Dalian. CN
  • Zhang, Ru; Dalian Medical University. First Affiliated Hospital. Department of Endocrinology. Dalian. CN
  • Bai, Ran; Dalian Medical University. First Affiliated Hospital. Department of Endocrinology. Dalian. CN
  • Liu, Dan; Dalian Medical University. First Affiliated Hospital. Department of Endocrinology. Dalian. CN
  • Wang, Yongbo; Dalian Medical University. First Affiliated Hospital. Department of Endocrinology. Dalian. CN
  • Zhang, Xueyang; Dalian Medical University. First Affiliated Hospital. Department of Endocrinology. Dalian. CN
  • Wang, Hao; Dalian Medical University. First Affiliated Hospital. Department of Endocrinology. Dalian. CN
  • Du, Jianling; Dalian Medical University. First Affiliated Hospital. Department of Endocrinology. Dalian. CN
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.
Subject(s)


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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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