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Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial.

Ji L, Li H, Guo X, Li Y, Hu R, Zhu Z - PLoS ONE (2013)

Bottom Line: Other endpoints included comparisons of metformin's effects on fasting plasma glucose (FPG), lipid levels and body weight.FPG levels decreased similarly over time in all BMI groups (P = 0.461) and changes from baseline in high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) did not differ significantly among BMI groups at week 16 (P = 0.143 and 0.451, respectively).Baseline BMI had no impact on glycemic control, weight change or other efficacy measures with metformin monotherapy.

View Article: PubMed Central - PubMed

Affiliation: Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China. jiln@bjmu.edu.cn

ABSTRACT

Background: Differences exist between treatment recommendations regarding the choice of metformin as first-line therapy for type 2 diabetes patients according to body mass index (BMI). This study compared the efficacy of metformin monotherapy among normal-weight, overweight, and obese patients with newly diagnosed type 2 diabetes.

Methods: In this prospective, multicenter, open-label study in China, patients aged 23-77 years were enrolled 1∶1:1 according to baseline BMI: normal-weight (BMI 18.5-23.9 kg/m(2); n = 125); overweight (BMI 24.0-27.9 kg/m(2); n = 122) or obese (BMI ≥28 kg/m(2); n = 124). Extended-release metformin was administered for 16 weeks (500 mg/day, up-titrated weekly to a maximum 2,000 mg/day). The primary efficacy endpoint was the effect of baseline BMI on glycemic control with metformin monotherapy, measured as the change from baseline in glycosylated hemoglobin (HbA1c) at week 16 compared among BMI groups using ANCOVA. Other endpoints included comparisons of metformin's effects on fasting plasma glucose (FPG), lipid levels and body weight.

Results: Mean HbA1c decreases at week 16, adjusted for baseline values, were -1.84%, -1.78% and -1.78% in normal-weight, overweight and obese patients, (P = 0.664); body weight decreased by 2.4%, 3.9% and 3.5%, respectively. FPG levels decreased similarly over time in all BMI groups (P = 0.461) and changes from baseline in high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) did not differ significantly among BMI groups at week 16 (P = 0.143 and 0.451, respectively).

Conclusions: Baseline BMI had no impact on glycemic control, weight change or other efficacy measures with metformin monotherapy. These data suggest that normal-weight type 2 diabetes patients would derive the same benefits from first-line treatment with metformin as overweight and obese patients, and are not at increased risk of excess weight loss.

Trial registration: ClinicalTrials.gov NCT00778622.

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CONSORT flow diagram of patient disposition.BMI, body mass index.
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pone-0057222-g001: CONSORT flow diagram of patient disposition.BMI, body mass index.

Mentions: This study (NCT00778622) was conducted at 20 hospitals in China between 19 November 2009 and 15 March 2011. A total of 371 patients aged 23−77 years were enrolled (Fig. 1). All these patients, who took at least one dose of study medication, were included in the safety analysis set or population; 334 patients who took one dose of study medication and had at least one post-baseline HbA1c assessment were included in the full analysis set (FAS) population. ‘Treatment failure’ was cited as a reason for study discontinuation by two participants (Fig. 1), in accordance with the study protocol, which stated that patients had to discontinue study treatment if FPG levels were >10.0 mmol/L (>180 mg/dL) at visits at week 4 or afterwards (week 8, week 12), and if this was confirmed by a repeated measurement one week later.


Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial.

Ji L, Li H, Guo X, Li Y, Hu R, Zhu Z - PLoS ONE (2013)

CONSORT flow diagram of patient disposition.BMI, body mass index.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3585309&req=5

pone-0057222-g001: CONSORT flow diagram of patient disposition.BMI, body mass index.
Mentions: This study (NCT00778622) was conducted at 20 hospitals in China between 19 November 2009 and 15 March 2011. A total of 371 patients aged 23−77 years were enrolled (Fig. 1). All these patients, who took at least one dose of study medication, were included in the safety analysis set or population; 334 patients who took one dose of study medication and had at least one post-baseline HbA1c assessment were included in the full analysis set (FAS) population. ‘Treatment failure’ was cited as a reason for study discontinuation by two participants (Fig. 1), in accordance with the study protocol, which stated that patients had to discontinue study treatment if FPG levels were >10.0 mmol/L (>180 mg/dL) at visits at week 4 or afterwards (week 8, week 12), and if this was confirmed by a repeated measurement one week later.

Bottom Line: Other endpoints included comparisons of metformin's effects on fasting plasma glucose (FPG), lipid levels and body weight.FPG levels decreased similarly over time in all BMI groups (P = 0.461) and changes from baseline in high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) did not differ significantly among BMI groups at week 16 (P = 0.143 and 0.451, respectively).Baseline BMI had no impact on glycemic control, weight change or other efficacy measures with metformin monotherapy.

View Article: PubMed Central - PubMed

Affiliation: Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China. jiln@bjmu.edu.cn

ABSTRACT

Background: Differences exist between treatment recommendations regarding the choice of metformin as first-line therapy for type 2 diabetes patients according to body mass index (BMI). This study compared the efficacy of metformin monotherapy among normal-weight, overweight, and obese patients with newly diagnosed type 2 diabetes.

Methods: In this prospective, multicenter, open-label study in China, patients aged 23-77 years were enrolled 1∶1:1 according to baseline BMI: normal-weight (BMI 18.5-23.9 kg/m(2); n = 125); overweight (BMI 24.0-27.9 kg/m(2); n = 122) or obese (BMI ≥28 kg/m(2); n = 124). Extended-release metformin was administered for 16 weeks (500 mg/day, up-titrated weekly to a maximum 2,000 mg/day). The primary efficacy endpoint was the effect of baseline BMI on glycemic control with metformin monotherapy, measured as the change from baseline in glycosylated hemoglobin (HbA1c) at week 16 compared among BMI groups using ANCOVA. Other endpoints included comparisons of metformin's effects on fasting plasma glucose (FPG), lipid levels and body weight.

Results: Mean HbA1c decreases at week 16, adjusted for baseline values, were -1.84%, -1.78% and -1.78% in normal-weight, overweight and obese patients, (P = 0.664); body weight decreased by 2.4%, 3.9% and 3.5%, respectively. FPG levels decreased similarly over time in all BMI groups (P = 0.461) and changes from baseline in high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) did not differ significantly among BMI groups at week 16 (P = 0.143 and 0.451, respectively).

Conclusions: Baseline BMI had no impact on glycemic control, weight change or other efficacy measures with metformin monotherapy. These data suggest that normal-weight type 2 diabetes patients would derive the same benefits from first-line treatment with metformin as overweight and obese patients, and are not at increased risk of excess weight loss.

Trial registration: ClinicalTrials.gov NCT00778622.

Show MeSH
Related in: MedlinePlus