A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00666718
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 374
- Diabetes Mellitus, Type 2
- Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
- Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
- Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2
- Capable and willing to follow the protocol
- Give written consent
- Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
- Have a history of severe hypoglycemia in the past 6 months
- Are pregnant or may become pregnant
- Women who are breastfeeding
- Have significant cardiac disease
- Have significant renal or liver disease
- Undergoing therapy for a malignancy
- Contraindications to the study medications
- Have an irregular sleep/wake cycle
- Have a serious disease or any condition considered by the investigator to be exclusionary
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glargine Insulin Glargine Glargine plus Insulin Lispro (2-3 injections) Glargine Insulin Lispro Glargine plus Insulin Lispro (2-3 injections) ILPS Insulin Lispro Protamine Suspension (ILPS) Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections) ILPS Insulin Lispro Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 Baseline, Week 24 Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AE) Baseline through Week 24 A listing of adverse events is located in the Reported Adverse Event module.
Change in Body Weight From Baseline to Week 24 Baseline, Week 24 LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
Change From Baseline in HbA1c at Week 12 and Week 24 Baseline, Week 12, Week 24 LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint 24 weeks LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.
Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint Week 24 Glycemic Variability at Endpoint Week 24 LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.
Total Daily Insulin Dose at Endpoint Week 24 LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
Number of Injections of Insulin at Week 24 Week 24 Rate Of All Self-reported Hypoglycemic Episodes Baseline through Week 24 Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Percentage of Participants With Self-Reported Hypoglycemic Episodes Baseline through Week 24 Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
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.
🇬🇧West Bromwich, West Midlands, United Kingdom