Clinical trial NCT00551538: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Diabetes
Diabetic
Insulin
Glargine
Lispro
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-10-31
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period.
timeFrame: At end of treatment arm or 3 months.
Secondary outcomes:
measure: HbA1c
timeFrame: At end of treatment arm or 3 months.
measure: 2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined
timeFrame: At end of treatment arm or 3 months.
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)
timeFrame: At end of treatment arm or 3 months.
measure: The number of patients with increased plasma glucose during the last 2 hours of each inpatient period
timeFrame: At end of treatment arm or 3 months.
measure: The mean amplitude of glycemic excursion
timeFrame: At end of treatment arm or 3 months.
measure: Concentration of plasma triglycerides and free fatty acids
timeFrame: At end of treatment arm or 3 months.
measure: Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value
timeFrame: At end of treatment arm or 3 months.
measure: Insulin dose and body weight
timeFrame: At end of treatment arm or 3 months.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: 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.
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
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)
role: STUDY_DIRECTOR
References:
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. doi: 10.1111/j.1464-5491.2006.01895.x.