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

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Lispro mix 75/25; Drug: Glargine

• Registration Number: NCT00551538
• Lead Sponsor: Eli Lilly and Company

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.

Study Timeline

• Study Start: 2003-05
• Study Completion: 2004-12
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Study First Posted: 2007-10-31
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-12
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Lispro mix 75/25	Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
2	Glargine	Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (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