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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00551538
First received: October 29, 2007
Last updated: October 12, 2010
Last verified: October 2010
  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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Lispro mix 75/25
Drug: Glargine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: At end of treatment arm or 3 months. ]
  • The mean amplitude of glycemic excursion [ Time Frame: At end of treatment arm or 3 months. ]
  • Concentration of plasma triglycerides and free fatty acids [ Time Frame: 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 [ Time Frame: At end of treatment arm or 3 months. ]
  • Insulin dose and body weight [ Time Frame: At end of treatment arm or 3 months. ]

Enrollment: 15
Study Start Date: May 2003
Study Completion Date: December 2004
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551538

Locations
United States, Indiana
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, 46202
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00551538     History of Changes
Other Study ID Numbers: 7505, F3Z-MC-IOOM
Study First Received: October 29, 2007
Last Updated: October 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Diabetes
Diabetic
Insulin
Glargine
Lispro

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014