NCT00751114已完成4 期
Superiority Study of Insulin Glargine Over Sitagliptin in Insulin-naïve Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- HbA1c: Change From Baseline to Study Endpoint
研究概览
简要总结
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period.
Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on:
- HbA1c level
- Fasting Plasma Glucose (FPG)
- 7-point plasma glucose (PG) profiles
- Percentage of patients with HbA1c <7% and <6.5%
Safety objectives consisted of:
- Hypoglycemia occurrence
- Body weight
- Overall safety
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With type 2 diabetes diagnosed for at least 6 months,
- •Not previously treated with insulin,
- •On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2 months
- •HbA1c ≥ 7 and < 11 %,
- •Body Mass Index (BMI) between 25 and 45 kg/m² inclusively,
- •Ability and willingness to perform plasma glucose (PG) monitoring using the Sponsor-provided PG meter and to complete the patient diary,
- •Signed informed consent obtained prior any study procedures,
- •Willingness and ability to comply with the study protocol.
排除标准
- •Treatment with oral antidiabetic drugs other than metformin within the last 3 months,
- •Previous treatment with the combination of metformin + sulfonylurea for more than 1 year,
- •Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonists or DiPeptidyl Peptidase (DPP) IV inhibitors,
- •FPG (assessed by central laboratory measurement) ≥ 280 mg/dL (15.4 mmol/L),
- •Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake...),
- •Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
- •In-patient care,
- •Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry),
- •Impaired renal function: serum creatinine ≥ 1.5 mg/dL (≥ 133µmol/L) or ≥ 1.4 mg/dL (≥ 124 µmol/L) in men and women, respectively,
- •History of sensitivity to the study drugs or to drugs with a similar chemical structure,
- •Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 3 x upper limit of normal range,
- •Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatment during the study that are not permitted during the study (exception: in case of chronic adrenal insufficiency, systemic glucosteroids are accepted only if the disease is stable and the treatment dose stable for at least 3 months before study entry),
- •Alcohol or drug abuse within the last year,
- •Night shift worker,
- •Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
- •Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant) within the last 3 months,
- •Participation in another clinical trial within the month prior to visit 1,
- •History of pancreatitis.
研究组 & 干预措施
Insulin Glargine
Experimental
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L).
干预措施: Insulin Glargine (Drug)
Insulin Glargine
Experimental
Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L).
干预措施: Metformin (Drug)
Sitagliptin
Active Comparator
Dose of 100 mg once a day administered with or without food.
干预措施: Sitagliptin (Drug)
Sitagliptin
Active Comparator
Dose of 100 mg once a day administered with or without food.
干预措施: Metformin (Drug)
结局指标
主要结局
HbA1c: Change From Baseline to Study Endpoint
时间窗: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.
次要结局
- HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint(study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14)
- HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint(study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14)
- Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint(baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value)
- 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint(baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14)
- Insulin Dose in the Insulin Glargine Group(visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value)
- Lipid Profile: Change From Baseline to Study Endpoint(baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14)
- Change in Body Weight From Baseline to Study Endpoint(baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value)
- Number of Patients With at Least One Episode of Symptomatic Hypoglycemia(During the treatment phase (24 weeks) plus 7 days after last dose)
- Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia(During the treatment phase (24 weeks) plus 7 days after last dose)
研究者
研究点 (1)
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Superiority study of insulin glargine over sitagliptin in insulin-naïve patients with type 2 diabetes treated with metformin and not adequately controlled - EASIEType 2 diabetes treated with metformin and not adequately controlledMedDRA version: 9.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlEUCTR2008-000516-32-PTsanofi aventis Groupe530