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

NCT00551538 | Completed Phase 4

• 2 other identifiers: 7505F3Z-MC-IOOM
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Diabetic; Insulin; Glargine; Lispro

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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.

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Lispro mix 75/25

2

ACTIVE COMPARATOR

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

Drug: Glargine

Interventions

Lispro mix 75/25 DRUG

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

1

Glargine DRUG

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

2

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 16842478 RESULT

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 31, 2007
• Study Start: May 1, 2003
• Study Completion: December 1, 2004
• Last Updated: October 13, 2010

Record last verified: 2010-10

Locations

US (1)