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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00666718

Purpose

This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension 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	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin lispro Insulin glargine Protamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Insulin Lispro Protamine Suspension provides non-inferior glycemic control to insulin glargine when these basal insulins are injected once daily together with insulin lispro injected 2-3 times daily. [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in HbA1c [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
Percentage of patients with HbA1c less than 7.0% and less than or equal to 6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
7-point self-monitored blood glucose profiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Incidence and rate of all self-reported hypoglycemic episodes [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]
Incidence of treatment-emergent adverse events [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]
Body weight change [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	380
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Glargine plus Insulin Lispro (2-3 injections) plus metformin	Drug: Insulin Glargine patient glucose-level dependent, injection, once daily in the evening, 24 weeks
2: Experimental Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin	Drug: Insulin Lispro Protamine Suspension patient glucose-level dependent, injection, once daily in the evening, 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 TZD) with insulin for at least 3 months prior to Visit 1
HbA1c greater than or equal to 7.5% and less than or equal to 11.0%
BMI greater than or equal to 25 and less than or equal to 45 kg/m2
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 an 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

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 46 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:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12047, F3Z-EW-IOPJ
Study First Received:	April 23, 2008
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00666718 History of Changes
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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Insulin
Calcium heparin
Hypoglycemic Agents

Diabetes Mellitus, Type 2
Glargine
Endocrinopathy
Protamines
Glucose Metabolism Disorders
Heparin
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Coagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Insulin

Pharmacologic Actions
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glargine
Protamines
Glucose Metabolism Disorders
Heparin Antagonists

ClinicalTrials.gov processed this record on May 07, 2009