ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00666718
Recruitment Status : Completed
First Posted : April 25, 2008
Results First Posted : March 25, 2011
Last Update Posted : May 13, 2011
Sponsor:
Information provided by:
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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 [ Time Frame: Baseline, Week 24 ]
    Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 12 and Week 24 [ Time Frame: Baseline, Week 12, Week 24 ]
    LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.

  2. Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint [ Time Frame: Week 24 ]
  3. 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint [ Time Frame: 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.

  4. Glycemic Variability at Endpoint [ Time Frame: 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.

  5. Rate Of All Self-reported Hypoglycemic Episodes [ Time Frame: 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.

  6. Percentage of Participants With Self-Reported Hypoglycemic Episodes [ Time Frame: 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.

  7. Number of Participants With Adverse Events (AE) [ Time Frame: Baseline through Week 24 ]
    A listing of adverse events is located in the Reported Adverse Event module.

  8. Change in Body Weight From Baseline to Week 24 [ Time Frame: Baseline, Week 24 ]
    LSMean values presented were controlled for treatment, country, and baseline HbA1C value.

  9. Total Daily Insulin Dose at Endpoint [ Time Frame: Week 24 ]
    LSMean values presented were controlled for treatment, country, and baseline HbA1C value.

  10. Number of Injections of Insulin at Week 24 [ Time Frame: Week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00666718     History of Changes
Other Study ID Numbers: 12047
F3Z-EW-IOPJ ( Other Identifier: Eli Lilly and Company )
First Posted: April 25, 2008    Key Record Dates
Results First Posted: March 25, 2011
Last Update Posted: May 13, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin Lispro
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants