A Study in Adults With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01421459
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 759
- Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification
- Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
- Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
- Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)
- Have significant liver, cardiac or gastrointestinal disease
- Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
- Have an excessive resistance to insulin or hypersensitivity to Lantus
- Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
- Have taken any other insulin other than Lantus within the past 30 days
- Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lantus + OAMs Lantus Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks LY2963016 + OAMs LY2963016 LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) \[alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)\] administered per standard of care for 24 weeks LY2963016 + OAMs OAMs LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) \[alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)\] administered per standard of care for 24 weeks Lantus + OAMs OAMs Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c) Baseline, Endpoint (up to 24 weeks) HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
- Secondary Outcome Measures
Name Time Method Insulin Dose Per Body Weight (U/kg) Per Day Endpoint (up to 24 weeks) Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5% Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks) Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
Change From Baseline in Insulin Antibody Levels Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks) Blood samples are collected from participants and percentage of insulin antibody binding measured. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline of response and treatment.
Change From Baseline in Body Weight Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk) Change from baseline in body weight. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Adult Low Blood Sugar Survey (ALBSS) 4 weeks (wk) and 12 wk and Endpoint (up to 24 wk) ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score range is 0 to 60 and Worry Total Score range is 0 to 72. Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. The ALBSS Total Scores (Worry and Behavior item scores combined) range is 0 to 132. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Insulin Dose (Units) Endpoint (up to 24 weeks) Units of insulin taken daily. Least Square (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1C, country, sulfonylurea use, time of basal insulin injection and treatment.
Change From Baseline in Hemoglobin A1c (HbA1c) Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
7-Point Self-Monitored Blood Glucose (SMBG) Profiles Baseline and Endpoint [up to 24 weeks (wk)] Seven-point SMBG are completed at the following timepoints: Morning (AM) Pre-Meal, Morning (AM) Post-Prandial (PP), Midday (MD) Pre-Meal, Midday PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Glycemic Variability of Fasting Blood Glucose Baseline and Endpoint (up to 24 weeks) Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning pre-meal blood glucose value from the 7-point self-monitoring blood glucose \[SMBG\] profiles. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Insulin Treatment Satisfaction Questionnaire (ITSQ) 4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk) ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen \[(IR) 5 items: domain scores range (DSR) 5-35\], Lifestyle Flexibility \[(LF) 3 items: DSR 3-21\], Glycemic Control \[(GC) 3 items: DSR 3-21\], Hypoglycemic Control \[(HC) 5 items: DSR 5-35\], Insulin Delivery Device \[(IDD) 6 items: DSR 6-42\]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100\*\[(7-mean raw score)/6\]. Higher scores indicate better treatment satisfaction. Least Squares (LS) mean are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.
Rate Per 30 Days of Hypoglycemic Events Baseline, Endpoint (up to 24 weeks) The rate of hypoglycemic events per 30 days between two visits is defined as the total number of events between the visits divided by the actual number of days between the visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.
Incidence of Hypoglycemic Events Baseline and Endpoint (up to 24 weeks) A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤70 milligrams/deciliter (mg/dL) even if it was not associated with signs, symptoms, or treatment consistent with current American Diabetes Association (ADA: 2005) guidelines. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇨🇳Yong Kung City, Taiwan