A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients - Full Text View

Purpose

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).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Insulin Glargine Drug: Insulin Lispro Protamine Suspension (ILPS) Drug: Insulin Lispro	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Protamine Insulin human Insulin lispro Insulin glargine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.

Secondary Outcome Measures:

Change From Baseline in HbA1c at Week 12 and Week 24 [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.
Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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.
Glycemic Variability at Endpoint [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
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.
Rate Of All Self-reported Hypoglycemic Episodes [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: Yes ]
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.
Number of Participants With Adverse Events (AE) [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: Yes ]
A listing of adverse events is located in the Reported Adverse Event module.
Change in Body Weight From Baseline to Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: Yes ]
LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
Total Daily Insulin Dose at Endpoint [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
Number of Injections of Insulin at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment:	374
Study Start Date:	April 2008
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Glargine Glargine plus Insulin Lispro (2-3 injections)	Drug: Insulin Glargine patient glucose-level dependent, injection, once daily in the evening, 24 weeks Drug: Insulin Lispro subcutaneous injections prior to meals, 24 weeks
Experimental: ILPS Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)	Drug: Insulin Lispro Protamine Suspension (ILPS) patient glucose-level dependent, injection, once daily in the evening, 24 weeks Other Name: LY275585 Drug: Insulin Lispro subcutaneous injections prior to meals, 24 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666718

Show 50 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00666718 History of Changes
Other Study ID Numbers:	12047, F3Z-EW-IOPJ
Study First Received:	April 23, 2008
Results First Received:	February 18, 2011
Last Updated:	May 11, 2011
Health Authority:	Greece: Ethics Committee Greece: National Organization of Medicines Turkey: Ministry of Health Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee Romania: National Medicines Agency Poland: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Italy: Ethics Committee Italy: Ministry of Health

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Glargine
Insulin
Insulin, Long-Acting

Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013