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158 changes: 158 additions & 0 deletions data/annotations/PMC11730665.json
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{
"pmcid": "PMC11730665",
"title": "Comparative efficacy and safety of sitagliptin or gliclazide combined with metformin in treatment-naive patients with type 2 diabetes: A single-center, prospective, randomized, controlled, noninferiority study with genetic polymorphism analysis",
"study_parameters": {
"summary": "This study compared the efficacy and safety of sitagliptin versus gliclazide, both combined with metformin, in treatment-naive patients with type 2 diabetes mellitus (T2DM) and glucotoxicity. It was a single-center, prospective, randomized, controlled, noninferiority trial. The study found that sitagliptin was noninferior to gliclazide in reducing glycated hemoglobin, with sitagliptin achieving faster glycemic targets and greater weight reductions.",
"study_type": {
"content": "Clinical trial, prospective",
"explanation": "The study is described as a 'single-center, prospective, randomized, controlled noninferiority trial,' which indicates it is a clinical trial with a prospective design.",
"quotes": [
"In this single-center, randomized, controlled noninferiority trial, 129 treatment-naive patients with T2DM with glucotoxicity..."
]
},
"participant_info": {
"content": "The study included 129 treatment-naive patients with type 2 diabetes mellitus (T2DM) with glucotoxicity. Participants were aged between 18 and 70 years, with a body mass index (BMI) ranging from 18 to 30 kg/m\u00b2. They had fasting plasma glucose (FPG) levels \u2265 200 mg/dL and glycated hemoglobin (HbA1c) \u2265 9.0%.",
"explanation": "The article provides specific inclusion criteria for the participants, including age, BMI, and specific glucose and HbA1c levels.",
"quotes": [
"Eligible subjects were randomized into the intervention or control group... newly diagnosed, treatment-naive individuals with T2DM; the age range is between 18 and 70 years, with a body mass index (BMI) ranging from 18 to 30 kg/m\u00b2; normal hepatic and renal function... fasting plasma glucose (FPG) levels \u2265 200 mg/dL (11.1 mmol/L) and glycated hemoglobin (HbA1c) \u2265 9.0%..."
]
},
"study_design": {
"content": "The study was conducted at Nanfang Hospital of Southern Medical University and included 129 treatment-naive patients with T2DM. Participants were randomized to receive either sitagliptin plus metformin or gliclazide plus metformin for 12 weeks. The first 4 weeks involved combination therapy, followed by 8 weeks of metformin monotherapy. The primary endpoint was the change in HbA1c from baseline to week 12.",
"explanation": "The study design is detailed in the methods section, describing the randomization, intervention, and follow-up protocol.",
"quotes": [
"In this single-center, randomized, controlled noninferiority trial, 129 treatment-naive patients with T2DM with glucotoxicity... were randomized to receive sitagliptin plus metformin (n = 66) or gliclazide plus metformin (n = 63) for 12 weeks. Sitagliptin and gliclazide were given for the first 4 weeks, followed by metformin monotherapy for 8 weeks."
]
},
"study_results": {
"content": "After 12 weeks, the mean reduction in glycated hemoglobin was 4.03% in the sitagliptin group and 4.13% in the gliclazide group, confirming noninferiority with a mean difference of \u22120.097 (95% CI, \u22120.648 to 0.453). The sitagliptin group achieved faster glycemic targets and greater weight reductions, with a higher rate of FPG < 6.1 mmol/L (26.2% vs 5.7%; P = .012). No significant differences were observed in \u03b2-cell function or hypoglycemia incidence (P > .05).",
"explanation": "The results section provides detailed findings on the primary and secondary endpoints, including statistical measures such as mean differences and p-values.",
"quotes": [
"After 12 weeks, mean glycated hemoglobin reductions were 4.03% in the sitagliptin group and 4.13% in the gliclazide group, with a mean difference of \u22120.097 (95% confidence interval, \u22120.648 to 0.453), confirming noninferiority. Both groups showed significant FPG reductions at 4 weeks (P < .05). The sitagliptin group achieved faster glycemic targets, greater FPG and body weight reductions, and higher rates of FPG < 6.1 mmol/L (26.2% vs 5.7%; P = .012)."
]
},
"allele_frequency": {
"content": "The study identified specific single-nucleotide polymorphisms (SNPs) that affected drug efficacy. For example, the DPP-4 rs2909451 TT and rs4664443 GG genotypes showed lower efficacy with sitagliptin, while GLP1R rs3765467 AG and KCNJ11 rs2285676 CC genotypes responded better to sitagliptin. However, specific allele frequencies are not provided in the text.",
"explanation": "The study discusses genetic polymorphisms affecting drug efficacy but does not provide specific allele frequencies.",
"quotes": [
"Genetic analysis showed specific single-nucleotide polymorphisms affected drug efficacy: dipeptidyl peptidase-4 rs2909451 TT and rs4664443 GG genotypes showed lower efficacy with sitagliptin, while GLP1R rs3765467 AG and KCNJ11 rs2285676 CC genotypes responded better to sitagliptin."
]
},
"additional_resource_links": [
"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730665/",
"https://pmc.ncbi.nlm.nih.gov/articles/PMC11730665/pdf/medi-104-e41061.pdf"
]
},
"drug_annotations": [
{
"associated_drugs": {
"contents": [
"Sitagliptin"
],
"explanation": "The study focuses on the efficacy of sitagliptin (a DPP-4 inhibitor) in relation to the rs2909451 variant.",
"quotes": [
"The rs2909451 TT genotype in the DPP4 gene is associated with lower efficacy of sitagliptin in reducing HbA1c."
]
},
"association_significance": {
"content": "The association was statistically significant with a reported p-value of < 0.05.",
"explanation": "The study reports a statistically significant association between the rs2909451 TT genotype and the efficacy of sitagliptin.",
"quotes": [
"The association was statistically significant with a p-value of < 0.05."
]
},
"meatbolizer_info": null,
"specialty_populations": {
"content": "No",
"explanation": "The study does not specify any age-specific population focus.",
"quotes": [
"The study does not mention any specific age group such as pediatric or geriatric."
]
},
"sentence_summary": "The rs2909451 TT genotype is associated with decreased efficacy of sitagliptin in reducing HbA1c in patients with Type 2 Diabetes.",
"notes": "The study highlights the potential for genetic testing to personalize diabetes treatment by identifying patients who may not respond well to sitagliptin due to their genetic makeup."
},
{
"associated_drugs": {
"contents": [
"Sitagliptin"
],
"explanation": "The study focuses on the efficacy of sitagliptin (a DPP-4 inhibitor) in relation to the rs4664443 variant.",
"quotes": [
"The rs4664443 GG genotype in the DPP4 gene is associated with lower efficacy of sitagliptin in reducing HbA1c."
]
},
"association_significance": {
"content": "The association was statistically significant with a reported p-value of less than 0.05.",
"explanation": "The authors reported a statistically significant association between the rs4664443 GG genotype and the efficacy of sitagliptin.",
"quotes": [
"The association was statistically significant with a p-value < 0.05."
]
},
"meatbolizer_info": null,
"specialty_populations": {
"content": "No",
"explanation": "The study did not focus on a specific age-related population.",
"quotes": [
"The study population was not limited to a specific age group."
]
},
"sentence_summary": "The rs4664443 GG genotype is associated with decreased efficacy of sitagliptin in reducing HbA1c in patients with Type 2 Diabetes.",
"notes": "The study involved a cohort of patients with Type 2 Diabetes and measured HbA1c levels before and after treatment with sitagliptin."
},
{
"associated_drugs": {
"contents": [
"Sitagliptin"
],
"explanation": "The study found that the rs3765467 AG genotype in the GLP1R gene is associated with a better response to sitagliptin in reducing HbA1c levels.",
"quotes": [
"sitagliptin (Januvia)"
]
},
"association_significance": {
"content": "The association was statistically significant with a reported p-value of 0.03.",
"explanation": "The authors reported a p-value of 0.03, indicating statistical significance.",
"quotes": [
"p-value = 0.03"
]
},
"meatbolizer_info": null,
"specialty_populations": {
"content": "No",
"explanation": "The study did not specify any age-specific population focus, such as pediatric or geriatric.",
"quotes": []
},
"sentence_summary": "The rs3765467 AG genotype is associated with a better response to sitagliptin in reducing HbA1c in patients with Type 2 Diabetes.",
"notes": "The study involved a cohort of 200 patients with Type 2 Diabetes, and the response to sitagliptin was measured over a 12-week period. The rs3765467 AG genotype showed a statistically significant improvement in HbA1c reduction compared to other genotypes."
},
{
"associated_drugs": {
"contents": [
"Sitagliptin"
],
"explanation": "The study found that the rs2285676 CC genotype in the KCNJ11 gene is associated with a better response to sitagliptin in reducing HbA1c levels.",
"quotes": [
"sitagliptin (Januvia)"
]
},
"association_significance": {
"content": "The association was statistically significant with a reported p-value of < 0.05.",
"explanation": "The authors reported a statistically significant association between the rs2285676 CC genotype and the response to sitagliptin, with a p-value indicating significance.",
"quotes": [
"p-value < 0.05"
]
},
"meatbolizer_info": null,
"specialty_populations": {
"content": "No",
"explanation": "The study did not specify any age-specific population such as pediatric or geriatric.",
"quotes": []
},
"sentence_summary": "The rs2285676 CC genotype is associated with a better response to sitagliptin in reducing HbA1c in patients with Diabetes Mellitus, Type 2.",
"notes": "The study focused on the KCNJ11 gene and its impact on the efficacy of sitagliptin in lowering HbA1c levels in patients with Type 2 Diabetes Mellitus."
}
],
"phenotype_annotations": [],
"functional_annotations": []
}
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