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临床试验/NCT00950599
NCT00950599已完成2 期

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-477118 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

AstraZeneca0 个研究点目标入组 423 人开始时间: 2003年5月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
AstraZeneca
入组人数
423
主要终点
Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 70 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Type 2 diabetes who are drug-naive
  • •Screening HbA1c ≥ 6.8% and ≤ 9.7%
  • •Screening fasting or random C-peptide > 0.5 ng/mL
  • •< 35 years old must be negative for anti-GAD antibodies
  • •Body Mass Index < 35 kg/m2

排除标准

  • •Symptoms of poorly controlled diabetes
  • •History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
  • •Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
  • •Significant cardiovascular history

研究组 & 干预措施

Saxagliptin (2.5 mg)

Experimental

干预措施: Saxagliptin (Drug)

Saxagliptin (5 mg)

Experimental

干预措施: Saxagliptin (Drug)

Saxagliptin (10 mg)

Experimental

干预措施: Saxagliptin (Drug)

Saxagliptin (20 mg)

Experimental

干预措施: Saxagliptin (Drug)

Saxagliptin (40 mg)

Experimental

干预措施: Saxagliptin (Drug)

Saxagliptin (100 mg)

Experimental

干预措施: Saxagliptin (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort

时间窗: Baseline, Week 12

Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.

Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort

时间窗: Baseline, Week 12

Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

次要结局

  • Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort(Baseline, Week 6)
  • Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort(Baseline, Week 6)
  • Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control(Week 4, Week 6)
  • Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort(up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations)
  • Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.(Baseline, Week 6)
  • Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 6)
  • Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort(Baseline, Week 12)
  • Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 14)
  • Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 10, Week 16)
  • Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 8, Week 14)
  • Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 10, Week 16)
  • Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 8, Week 14)
  • Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts(Baseline, Week 10, Week 16)
  • Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort(Baseline, Week 6)
  • Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.(Baseline, Week 6)
  • Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort(Baseline, Week 6)
  • Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort(Week 6)
  • Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort(up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations)
  • Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort(From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations)
  • Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort(From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

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