Expired Study
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Indianapolis, Indiana 46202


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

7505


NCT ID:

NCT00551538


Secondary ID:

F3Z-MC-IOOM


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:May 2003
Completion Date:December 2004
Completion Type:Actual
Verification Date:October 2010
Last Changed Date:October 12, 2010
First Received Date:October 29, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period.
Time Frame:At end of treatment arm or 3 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:HbA1c
Time Frame:At end of treatment arm or 3 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined
Time Frame:At end of treatment arm or 3 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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)
Time Frame:At end of treatment arm or 3 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The number of patients with increased plasma glucose during the last 2 hours of each inpatient period
Time Frame:At end of treatment arm or 3 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The mean amplitude of glycemic excursion
Time Frame:At end of treatment arm or 3 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Concentration of plasma triglycerides and free fatty acids
Time Frame:At end of treatment arm or 3 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value
Time Frame:At end of treatment arm or 3 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Insulin dose and body weight
Time Frame:At end of treatment arm or 3 months.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Lispro mix 75/25
Description:Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
Arm Name:1
Intervention Type:Drug
Name:Glargine
Description:SC injection, once-daily, given in conjunction with oral antidiabetic medications.
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
Study Arm Type:Active Comparator
Arm Name:2
Description:Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:16842478

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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