CTRI/2010/091/000098已完成3 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF DUTOGLIPTIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS ON BACKGROUND TREATMENT WITH PIOGLITAZONE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion and exclusion criteria for participant selection, including age and sex.
- •Age 18 to 85
- •To be eligible to participate in the study, patients must meet the following criteria:
- •At the Screening Visit (Visit 1):
- •1.Be able to understand and provide written informed consent before participating in any study-related procedures
- •2.Be male or female outpatients 18 to 85 years of age, inclusive
- •3.Be willing to return for all clinic visits and complete all study-related procedures, including self-monitoring of blood glucose
- •4.Have a body mass index of 20 to 48 kg/m2
- •5.Have stable weight, with no more than a 7% gain or loss in the previous 3 months
- •6.Be diagnosed with T2DM at least 3 months before the screening visit ( visit1).Verification of diagnosis should be made by obtaining documentation or written confirmation from the physician treating the patients?s diabetes.
- •7.If taking a medication(s) for hypertension (including a diuretic), be taking a stable dose for at least 4 weeks before study start
- •8.If taking a medication(s) other than an antidiabetic that might affect blood glucose level, be taking a stable dose for at least 4 weeks before study start
- •9.Have a thyroid-stimulating hormone level on laboratory testing at screening that is within the reference range provided by the central laboratory. If the patient is taking thyroid hormone, the dose must have been stable for at least 6 weeks before study start
- •10.Be willing to discontinue, for the duration of the study, all herbal medication taken for the treatment of diabetes
- •11.Have a fasting serum C-peptide > 0.26 nmol/L ( > 0.8 ng/mL; > 260 pmol/L) on laboratory testing at screening
- •12.Female patients must not be pregnant, not planning to become pregnant during the course of the study, and not lactating. Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test on laboratory testing at screening
- •13. If of childbearing potential ( or having partner(s) of childbearing potential), must be willing to use an adequate method of contraception and not become pregnant (or have partner[s] become pregnant) for the duration of the study. Adequate contraceptive methods include, but are not limited to, oral contraceptives (stable use for 2 or more cycles before screening); intrauterine devices; Depo Provera; Norplant System implants; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam, or jelly; and abstinence.
- •14.Have an HbA1c level >= 7.0% and <= 10.0%
- •15.Be drug-treatment naïve, or treated with a stable dose of pioglitazone or rosiglitazone, or treated with a stable dose of any other oral hypoglycemic agent (OHA) as monotherapy at the time of the Screening Visit (Visit 1):
- •â??Drug-treatment naïve means never having received an OHA or parenteral medication (insulin or GLP-1 analogue) or, if having received an OHA or parenteral medication, been off said OHA or parenteral medication for a minimum of 6 weeks (12 weeks for pioglitazone or rosiglitazone) before Visit 1
- •â??Stable dose of pioglitazone or rosiglitazone means a minimum of 12 weeks
- •â??Stable dose of any other OHA as monotherapy means a minimum of 6 weeks
- •16. Be willing to refrain from donating blood during the study and up to 1 month aft
排除标准
- •Patients who meet any of the following criteria will not be eligible to participate in the study:
- •1.Currently taking more than one OHA
- •2.Have been treated as an outpatient with insulin or a GLP-1 analogue,or a DPP4 inhibitor within 6 weeks of the Screening Visit (Visit 1)3.Have type 1 diabetes mellitus, maturity-onset diabetes of the young, insulin requiring T2DM, other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis
- •4.Have elevated blood glucose levels owing to medical treatment or to a concurrent medical condition other than T2DM (eg, hyperadrenocorticalism due to Cushing syndrome [or Cushing disease], pheochromocytoma, acromegaly, hyperthyroidism, other endocrine disorder that can raise blood glucose)
- •5.Have skin lesions (eg, discoloration, swelling, atrophy, ulceration), edema states, or diabetic foot ulcers considered medically important by the Investigator
- •6.Have a history of epilepsy, not including childhood febrile seizures
- •7.Have a history of hypoglycemic episode requiring glucose, glucagon, orange juice, etc administered by a second person during the 6 months before the Screening Visit (Visit 1)
- •8.Have a history of hyperosmolar, hyperglycemic, or nonketotic syndrome during the 6 months before the Screening Visit (Visit 1)
- •9.Have had a stroke, myocardial infarction, symptomatic coronary artery disease, angina, or arrhythmia within 4 weeks before the Screening Visit (Visit 1) or a history of class III or class IV congestive heart failure (according to the New York Heart Association functional classification system)
- •10.Have a history of or risk factors for acute pancreatitis (eg, alcohol abuse, extreme hypertriglyceridemia [> 1000 mg/dL], multiple small gallstones) or exacerbation of chronic pancreatitis
- •11.Have a systolic blood pressure (SBP) ≥ 160 mm Hg or < 90 mm Hg and/or diastolic blood pressure (DBP) ≥ 100 mm Hg or < 50 mm Hg at the Screening Visit (Visit 1). The measurement at the Screening Visit (Visit 1) can be repeated if the initial reading is felt to be inaccurate or unrepresentative of the patient?s usual blood pressure value
- •12.Have had gastrointestinal surgery for obesity (including bypass, gastroplasty, and banding procedures) within 1 year before the Screening Visit (Visit 1) or have plans to have such surgery or procedures for the removal of excess fatty tissue (eg, liposuction, breast reduction) during the course of the study
- •13.Have started a weight-loss regimen within 4 weeks of the Screening Visit (Visit 1), either on one?s own or by participating in a commercial behavior modification/diet program (eg, Jenny Craig, Weight Watchers) or by taking a medication for weight reduction (eg, phentermine, sibutramine, Xenical/Alli [orlistat])
- •14.Currently taking an antipsychotic medication (except prochlorperazine as needed for nausea), have taken systemic glucocorticoids at a dose > 5 mg of prednisone or equivalent daily within the 2 weeks before the Screening Visit (Visit 1), or currently taking products intended to stimulate appetite (eg, megestrol acetate [Megace]). (See the Study Reference Manual for prednisone equivalence of other glucocorticoids)
- •15.Have a history of cancer other than treated basal-cell or squamous-cell carcinoma of the skin. (Note: Patients with a history of cancer are allowed to participate provided that the malignancy has been in complete remission for at least 5 years before the Screening Visit [Visit 1]. Compl
研究者
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