EUCTR2012-004531-23-GB进行中（未招募）1 期
A 24-Week International, Multi-center, Randomized, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adult Subjects with Type 2 Diabetes who have Inadequate Glycemic Control with Diet and Exercise
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,736
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Subjects must be willing and able to give signed and dated written informed consent.
- •- Subjects with T2DM with inadequate glycemic control on diet and exercise alone (ie, treatment naive defined as no treatment with anti-diabetic antihyperglycemic medication within 90 days prior to enrollment and no more than a total of 14 days with the exception of insulin treatment for gestational diabetes and during periods of hospitalization), defined as central laboratory HbA1c >= 7.0% and <= 9.2% obtained at the screening visit. A cap of 70% of subjects with HbA1c >= 7.0 and <= 8.0% will be applied at screening. If central laboratory HbA1c = 6.9% at screening, a single central laboratory repeat HbA1c within 30 days is allowed.
- •Note: Enrollment of subjects into the randomized treatment period, will require HbA1c >= 7.0% and <= 9.2% at Week -1 of the study.
- •- FPG < 250 mg/dL (13.9 mmol/L).
- •- C-peptide >= 1.0 ng/mL (0.34 nmol/L) at enrollment visit.
- •- BMI =< 45.0 kg/m2 at the enrollment visit.
- •- Men and women, aged >= 18 years old at enrollment visit.
- •- Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in Appendix 1. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required.
- •The individual methods of contraception and duration should be determined in consultation with the investigator. OCBP must follow instructions for birth control when the half life of the investigational drug is less than 24 hours, contraception should be continued for a period of 30 days after the last dose of investigational product.
- •- Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
- •- Women must not be breastfeeding.
- •- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control when the half life of the investigational drug is less than 24 hours, contraception should be continued for a period of 90 days after the last dose of investigational product.
- •- Women who are not of childbearing potential and azoospermic men do not require contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 568
排除标准
- •- Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with >10% weight loss during last 3 months prior to Visit 1 or other signs and symptoms.
- •- History of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma.
- •- Severe uncontrolled hypertension defined as systolic blood pressure (SBP) >= 160 mmHg and/or diastolic blood pressure (DBP) >= 100 mmHg.
- •- Cardiovascular disease within 2 months of the screening visit[ie, myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, stroke or transient ischemic attack (TIA).
- •- Congestive heart failure as New York Heart Association (NYHA) class III or IV.
- •- History of unstable or rapidly progressing renal disease.
- •- Significant hepatic disease, including, but not limited to, chronic hepatitis and/or severe hepatic insufficiency, including subjects with ALT and/or AST > 3x ULN and or total bilirubin > 2 mg/dL.
- •- Moderate or severe impairment of renal function defined as eGFR < 60 mL/min/1.73m2 (estimated by MDRD).
- •- Serum creatinine >= 1.50 mg/dL (133 umol/L) for male subjects; serum creatinine >= 1.40 mg/dL (124 umol/L) for female subjects.
- •- Hemoglobin =< 11.0 g/dL (110 g/L) for men; hemoglobin =< 10.0 g/dL (100 g/L) for women.
- •- Abnormal free T4 values. Abnormal thyroid stimulating hormone (TSH) value at screening will be further evaluated by free T4. Subjects with abnormal free T4 values will be excluded.
- •- Positive for hepatitis B surface antigen
- •- Positive for anti-hepatitis C virus antibody.
- •- Creatine kinase CK >= 3X ULN.
- •- Contraindication to metformin as per local label/prescription information.
- •- Documented history of hepatotoxicity with any medication.
- •- Women who are pregnant.
- •- Prisoners or subjects who are involuntarily incarcerated.
- •- Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- •- Administration of any other investigational drug or participation in any interventional clinical studies within 30 days of planned screening to this study.
- •- Subject is a participating investigator, study coordinator, employee of an investigator or immediate family member of any of the aforementioned.
研究者
相似试验
进行中（未招募）
1 期
Phase 4: Investigational study to evaluate metformin XR monotherapy versus metformin IR monotherapy in subjects with type 2 diabetes.Type 2 Diabetes.MedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-004531-23-CZBristol-Myers Squibb International Corporation1,756
进行中（未招募）
1 期
Phase 4: Investigational study to evaluate metformin XR monotherapy versus metformin IR monotherapy in subjects with type 2 diabetes.Type 2 Diabetes.MedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-004531-23-HUBristol-Myers Squibb International Corporation1,048
进行中（未招募）
1 期
Phase 4: Investigational study to evaluate metformin XR monotherapy versus metformin IR monotherapy in subjects with type 2 diabetes.Type 2 Diabetes.MedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-004531-23-PLBristol-Myers Squibb International Corporation1,048
进行中（未招募）
1 期
Phase 4: Investigational study to evaluate metformin XR monotherapy versus metformin IR monotherapy in subjects with type 2 diabetes.Type 2 Diabetes.MedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-004531-23-DEBristol-Myers Squibb International Corporation1,756
进行中（未招募）
1 期
A comparison of treatment with Saxagliptin and Dapagliflozin against Insulin Glargine in Type 2 Diabetes patients whose current treatment of Metformin with or without Sulfonylurea Therapy is not adequate.Type 2 diabetes mellitus and inadequate glycemic control on a stable dose of metforminMedDRA version: 19.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861MedDRA version: 19.0Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000004861MedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2015-001702-33-HUAstraZeneca AB598