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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Lispro mix 75/25; Drug: Glargine

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• 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.

Helpful Links

• Lilly Clinical Trial Registry

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: October 29, 2007
• First Submitted That Met QC Criteria: October 29, 2007
• First Posted (Estimate): October 31, 2007

Study Record Updates

• Last Update Posted (Estimate): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 12, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Diabetes; Insulin; Diabetic; Lispro; Glargine
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: 7505; F3Z-MC-IOOM