24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00551538

Purpose

The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Lispro mix 75/25 Drug: Glargine	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, Crossover Assignment, Safety/Efficacy Study
Official Title:	Twenty-Four-Hour Plasma Glucose Profiles Observed in Patients With Type 2 Diabetes During Therapy Consisting of Oral Agent(s) Plus Twice-Daily Insulin Lispro Low Mixture or Once-Daily Insulin Glargine

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period. [ Time Frame: At end of treatment arm or 3 months. ]

Secondary Outcome Measures:

HbA1c [ Time Frame: At end of treatment arm or 3 months. ]
2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined [ Time Frame: At end of treatment arm or 3 months. ]
Plasma glucose AUC excursions during a 24 hours when plasma glucose exceeds the following: greater than or equal to 7.5 mmol/L (135 mg/dL), greater than or equal to 7.8 mmol/L (140 mg/dL), and greater than or equal to 10.0 mmol/L (180 mg/dL) [ Time Frame: At end of treatment arm or 3 months. ]
The number of patients with increased plasma glucose during the last 2 hours of each inpatient period [ Time Frame: At end of treatment arm or 3 months. ]
The mean amplitude of glycemic excursion [ Time Frame: At end of treatment arm or 3 months. ]
Concentration of plasma triglycerides and free fatty acids [ Time Frame: At end of treatment arm or 3 months. ]
Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value [ Time Frame: At end of treatment arm or 3 months. ]
Insulin dose and body weight [ Time Frame: At end of treatment arm or 3 months. ]

Enrollment:	15
Study Start Date:	May 2003
Study Completion Date:	December 2004

Arms	Assigned Interventions
1: Active Comparator Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.	Drug: Lispro mix 75/25 Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
2: Active Comparator Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.	Drug: Glargine SC injection, once-daily, given in conjunction with oral antidiabetic medications.

Detailed Description:

The primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have type 2 diabetes
Have inadequate overall glycemic control (hemoglobin A1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to Visit 1
Have used:
- single or multiple OAMs for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or
- insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or
- a combination of the above.
Are greater than or equal to 21 and less than 80 years of age
As determined by the investigator, are capable and willing to:
- comply with their prescribed diet and medication regimen,
- perform self blood glucose monitoring,
- use the patient diary as required for this protocol,
- participate in two 24 hour inpatient assessments

Exclusion Criteria:

Have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
Are currently treated with a meglitinide without sulfonylurea
Have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
Have plasma creatinine greater than or equal to 1.5 mg/dL (for males) or greater than or equal to 1.4 mg/dL (for females) for patients who will be treated with metformin or; greater than 2 mg/dL for patients treated with other OAMs, as determined by a local laboratory
Have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to Visit 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551538

Locations

United States, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States, 46202

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

Study ID Numbers:	7505, F3Z-MC-IOOM
Study First Received:	October 29, 2007
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00551538
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Diabetes
Diabetic
Insulin
Glargine
Lispro

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 15, 2009