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
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 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