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

NCT ID: NCT00551538

Last Updated: 2010-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2004-12-31

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.

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.

Group Type: ACTIVE_COMPARATOR

Lispro mix 75/25

Intervention Type: DRUG

Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.

2

Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.

Group Type: ACTIVE_COMPARATOR

Glargine

Intervention Type: DRUG

SC injection, once-daily, given in conjunction with oral antidiabetic medications.

Interventions

Lispro mix 75/25

Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.

Intervention Type: DRUG

Glargine

SC injection, once-daily, given in conjunction with oral antidiabetic medications.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United States

References

Roach P, Malone JK. Comparison of insulin lispro mixture 25/75 with insulin glargine during a 24-h standardized test-meal period in patients with Type 2 diabetes. Diabet Med. 2006 Jul;23(7):743-9. doi: 10.1111/j.1464-5491.2006.01895.x.

Reference Type: RESULT

PMID: 16842478 (View on PubMed)

Other Identifiers

F3Z-MC-IOOM

Identifier Type: -

Identifier Source: secondary_id

7505

Identifier Type: -

Identifier Source: org_study_id