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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551538
• Other study ID #: 7505
• Secondary ID: F3Z-MC-IOOM
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2007
• Last updated: October 12, 2010
• Start date: May 2003
• Est. completion date: December 2004

Study information

• Verified date: October 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Lispro mix 75/25
Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
• Glargine
SC injection, once-daily, given in conjunction with oral antidiabetic medications.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c		At end of treatment arm or 3 months.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	The mean amplitude of glycemic excursion		At end of treatment arm or 3 months.
Secondary	Concentration of plasma triglycerides and free fatty acids		At end of treatment arm or 3 months.
Secondary	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.
Secondary	Insulin dose and body weight		At end of treatment arm or 3 months.

External Links

•   Lilly Clinical Trial Registry