24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00551538

Collaborator

(none)

Enrollment

Location

Arms

19.1

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Lispro mix 75/25 Drug: Glargine	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2003

Actual Study Completion Date :

Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 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.
Active Comparator: 2 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.

Arm

Intervention/Treatment

Active Comparator: 1

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.

Active Comparator: 2

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c [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 [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) [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 [At end of treatment arm or 3 months.]
The mean amplitude of glycemic excursion [At end of treatment arm or 3 months.]
Concentration of plasma triglycerides and free fatty acids [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 [At end of treatment arm or 3 months.]
Insulin dose and body weight [At end of treatment arm or 3 months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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