Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00664534

Purpose

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Insulin Glargine Drug: Insulin Lispro Premix (mid-mixture and low-mixture)	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine Dextrose Insulin lispro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Premixed Insulin Lispro Low-Mixture and Mid-Mixture Regimens With Separate Basal and Bolus Insulin Injections in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Oral Therapy Who Consume Light Breakfast

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Baseline adjusted HbA1c at endpoint [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients using each possible final insulin regimen [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Mean change in HbA1c overtime [ Time Frame: 16 weeks, 32 weeks, and 48 weeks ] [ Designated as safety issue: No ]
Percentage of patients achieving HbA1c less than or equal to 6.5% and less than 7% over time [ Time Frame: 16 weeks, 32 weeks and 48 weeks ] [ Designated as safety issue: No ]
7-point self-monitored blood glucose profiles [ Time Frame: Baseline, 16 weeks, 32 weeks and 48 weeks ] [ Designated as safety issue: No ]
Mean change from baseline in postprandial blood glucose [ Time Frame: 16 weeks, 32 weeks and 48 weeks ] [ Designated as safety issue: No ]
Mean daily total, basal and prandial insulin dose [ Time Frame: 16 weeks, 32 weeks and 48 weeks ] [ Designated as safety issue: No ]
Body weight change [ Time Frame: From baseline to endpoint ] [ Designated as safety issue: Yes ]
Incidence and rate of all self-reported hypoglycemic episodes [ Time Frame: Baseline to 48 weeks ] [ Designated as safety issue: Yes ]
Incidence of treatment-emergent adverse events [ Time Frame: Baseline to 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Glargine +/- 1,2 or 3 injections of insulin lispro plus OAMs	Drug: Insulin Glargine patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks
2: Experimental Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs	Drug: Insulin Lispro Premix (mid-mixture and low-mixture) patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks

Eligibility

Ages Eligible for Study:	30 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diabetes Mellitus, Type 2
have been receiving metformin plus at least one other oral antihyperglycemic medication (sulfonylurea or TZD) without insulin, for at least 90 days prior to Visit 1
HbA1c greater than or equal to 7.0% and less than 11.0%
regularly consume a light breakfast (less than 15% of total daily calorie intake)
capable and willing to follow the protocol
give written consent

Exclusion Criteria:

are taking a TZD whose country label does not allow in combination with insulin
are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
have a body mass index greater than 40 kg/m2
have a history of severe hypoglycemia in past 24 weeks
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 study medications
have an irregular sleep/wake cycle

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664534

Contacts

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

1-317-615-4559

Show 33 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:	11806, F3Z-EW-S020
Study First Received:	April 21, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00664534
Health Authority:	Romania: National Medicines Agency; Spain: Ethics Committee; Spain: Spanish Agency of Medicines; Canada: Health Canada; Mexico: Ministry of Health; Mexico: Ethics Committee; Brazil: National Committee of Ethics in Research; Egypt: Ministry of Health and Population; Saudi Arabia: Research Advisory Council; Portugal: Ethics Committee for Clinical Research; Portugal: National Pharmacy and Medicines Institute; Turkey: Ministry of Health

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009