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 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

ChemIDplus related topics:

Insulin Insulin glargine Dextrose Insulin lispro 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 43 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

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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12047, F3Z-EW-IOPJ
First Received:	April 23, 2008
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00666718
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

Diabetes Mellitus, Type 2

Glargine

Endocrinopathy

Protamines

Glucose Metabolism Disorders

Metabolic disorder

Heparin

Additional relevant MeSH terms:

Hypoglycemic Agents

Coagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Physiological Effects of Drugs

Heparin Antagonists

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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