NCT01894568已完成3 期
A Phase 3, Open Label, Randomized, Parallel, 26 Week Treatment Study Comparing LY2605541 With Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti Hyperglycemia Medications in Asian Insulin Naïve Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications. Participants will receive 26 weeks of 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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin
- •Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening
- •Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central laboratory at screening
- •Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m^2)
- •Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose (SMBG)
- •Record keeping as required by this protocol
- •Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening, do not plan to become pregnant during the study, have practiced reliable birth control during the study and 2 weeks following the last dose of investigational product
排除标准
- •Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions
- •Have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist within 3 months prior to screening
- •Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
- •Local OAM restrictions: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- •Are taking, or have taken within 3 months before screening, prescription or over-the-counter medications to promote weight loss
- •Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening
- •Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the past 6 months
- •Have cardiac disease with functional status that is New York Heart Association Class III or IV
- •Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ≥2.0 milligram per deciliter (mg/dL) (177 micromole per liter [μmol/L]). Participants taking metformin should not exceed the creatinine level specified in the local label
- •Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or any chronic hepatitis, non alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
- •Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
- •Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
- •Have known hypersensitivity or allergy to any of LY2605541 and insulin glargine or their excipients
- •Have pre proliferative and proliferative retinopathy, maculopathy requiring treatment or not clinically stable in the last 6 months, or participants with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months
- •Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
- •Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening as determined by the central laboratory
- •Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
研究组 & 干预措施
Insulin Peglispro
Experimental
Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs).
干预措施: Insulin Peglispro (Drug)
Insulin Peglispro
Experimental
Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs).
干预措施: Oral Antihyperglycemic Medications (OAMs) (Drug)
Insulin Glargine
Active Comparator
Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs.
干预措施: Insulin Glargine (Drug)
Insulin Glargine
Active Comparator
Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs.
干预措施: Oral Antihyperglycemic Medications (OAMs) (Drug)
结局指标
主要结局
Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)
时间窗: Baseline, Week 26
Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein \[LDL-C\], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.
次要结局
- 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events(Baseline to Week 26)
- 9-Point Self-Monitored Blood Glucose (SMBG)(Week 0 and Week 26)
- Percentage of Participants With HbA1c ≤6.5%(Week 26)
- Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26(Week 26)
- Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c)(Baseline, Week 12)
- Fasting Serum Glucose (FSG)(Weeks 0 and 26)
- Fasting Blood Glucose (FBG)(Weeks 0 and 26)
- Change From Baseline to Week 26 in Body Weight(Baseline, Week 26)
- Insulin Dose Per Kilogram (kg) of Body Weight(Week 26)
- Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose])(Week 26)
- Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26(Week 26)
- Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26(Baseline, Week 26)
- Insulin Treatment Satisfaction Questionnaire (ITSQ) Score(Week 4 and 26)
- Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores(Baseline, Week 26)
- Intra-Participant Variability of the Fasting Blood Glucose (FBG)(Week 26)
- Percent Hemoglobin A1c at Week 26(Week 26)
- Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)(Baseline to Week 26)
研究者
研究点 (1)
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