NCT00434954已完成3 期
Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Hemoglobin (HbA1c)
研究概览
简要总结
This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start
- •Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start
- •Have an HbA1c between 6.5% and 10.0%, inclusive
- •Have a body mass index (BMI) between 25 kg/m^2 and 40 kg/m^2, inclusive
排除标准
- •Have type 1 diabetes or known latent autoimmune diabetes in adults
- •Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start
- •Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)
- •Have used any prescription drug to promote weight loss within 3 months prior to study start
- •Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry
- •Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs
研究组 & 干预措施
Exenatide Twice Daily (BID)
Experimental
干预措施: exenatide twice daily (BID) (Drug)
Premixed Insulin Aspart Twice Daily (BID)
Active Comparator
干预措施: premixed insulin aspart twice daily (BID) (Drug)
结局指标
主要结局
Change in Glycosylated Hemoglobin (HbA1c)
时间窗: Baseline and 26 weeks
Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)
Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)
时间窗: 26 weeks
Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26
次要结局
- Percentage of Subjects Achieving HbA1c Target of < 6.5%(26 weeks)
- 7 Point Self-monitored Blood Glucose (SMBG) Profiles(Baseline and 26 weeks)
- Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)(26 weeks)
- Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)(Baseline and 26 weeks)
- Percentage of Subjects Achieving HbA1c Target of < 7.0%(26 weeks)
- Change in Body Weight(Baseline and 26 weeks)
- Patient Reported Outcomes: Quality of Life (SF-12)(Baseline and 26 weeks)
- Change in Body Mass Index (BMI)(Baseline and 26 weeks)
- Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)(26 weeks)
- Blood Lipid Levels(Baseline and 26 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS PatientsPolycystic Ovary SyndromeNCT04029272Peking Union Medical College Hospital80
已完成
4 期
Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 DiabetesType2 DiabetesNCT03297879Beijing Chao Yang Hospital230
已完成
4 期
Research of Exenatide for Overweight/Obese PCOS Patients With IGRPolycystic Ovary SyndromeOverweight and ObesityDisorder of Glucose RegulationNCT03352869RenJi Hospital183
已完成
4 期
The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-DiabetesImpaired Glucose ToleranceNCT00546728St. Paul Heart Clinic50
已完成
3 期
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and MetforminType 2 Diabetes MellitusNCT00324363AstraZeneca466