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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00666718
First received: April 23, 2008
Last updated: May 11, 2011
Last verified: May 2011
  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:


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
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, see Learn About Clinical Studies.

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:
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, Globin Zinc
Glargine
Insulin
Insulin Lispro
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 August 20, 2014