A Comparison of LY2605541 Versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With 2 or More Oral Antihyperglycemic Medications: An Open-Label, Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 641
- 试验地点
- 1
- 主要终点
- Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks:
- Change in participants' overall blood sugar control
- The rate of night time low blood sugar episodes
- The number of participants that reach blood sugar targets without low night time blood sugar episodes
- The total number of low blood sugar episodes reported
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin
- •Have been receiving 2 or more OAMs for at least 3 months prior to the study
- •Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, at screening
- •Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
- •Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
排除标准
- •Have used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
- •Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before screening
- •For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- •Are taking, or have taken within the 90 days 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 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 greater than or equal to 2 milligrams per deciliter (mg/dL) [177 millimoles per liter (mmol/L)]
- •Have obvious clinical signs or symptoms of liver disease [excluding nonalcoholic fatty liver disease (NAFLD)], acute or chronic hepatitis, nonalcoholic 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
- •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
- •Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
- •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
研究组 & 干预措施
LY2605541
Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks.
干预措施: LY2605541 (Drug)
LY2605541
Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks.
干预措施: Oral Antihyperglycemic Medications (OAM) (Drug)
Human Insulin NPH
Administered by SC injection once daily at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal.
干预措施: Human Insulin NPH (Drug)
Human Insulin NPH
Administered by SC injection once daily at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal.
干预措施: Oral Antihyperglycemic Medications (OAM) (Drug)
结局指标
主要结局
Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
时间窗: Baseline, 26 Weeks
Glycosylated hemoglobin A1 (HbA1c) is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
次要结局
- Percentage of Participants With HbA1c ≤6.5% and <7.0%(26 Weeks)
- Change From Baseline to 26 Weeks in Body Weight(Baseline, 26 Weeks)
- Fasting Serum Glucose (FSG) (by Laboratory)(26 Weeks)
- Time to Steady-State (Stable Maximum Dose)(Baseline through 26 Weeks)
- Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores(Baseline, 26 Weeks)
- Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia(26 Weeks)
- Percentage of Participants With Severe Hypoglycemic Events(Baseline through 26 Weeks)
- 6-Point Self-Monitored Blood Glucose (SMBG)(26 Weeks)
- Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index(Baseline, 26 Weeks)
- Insulin Treatment Satisfaction Questionnaire (ITSQ) Score(26 Weeks)
- HbA1c(26 Weeks)
- Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores(Baseline, 26 Weeks)
- 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events(Baseline through 26 Weeks)
- Fasting Blood Glucose (FBG) (by Self Monitoring)(26 Weeks)
- Insulin Dose Per Kilogram (kg) of Body Weight(26 Weeks)
- Change From Baseline to 26 Weeks in Lipid Profile(Baseline, 26 Weeks; Baseline, End Of Study (EOS) (Up to 30 Weeks))
- Intra-Participant Variability in FBG by Standard Deviation(26 Weeks)
- Intra-Participant Variability in FBG by the Coefficient of Variation(26 Weeks)
- Percentage of Participants With Total and Nocturnal Hypoglycemic Events(Baseline through 26 Weeks)
- Rate of Severe Hypoglycemic Events(Baseline through 26 Weeks)
- Percentage of Participants With Insulin Antibodies(Baseline to 26 Weeks)
- Percentage of Participants With Injection Site Reactions(Baseline through 26 Weeks)