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

Lilly

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Glargine; Drug: Lispro mix 75/25

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551538

7505

F3Z-MC-IOOM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

1

Active Comparator group

Description:

Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.

Treatment:

Drug: Lispro mix 75/25

2

Active Comparator group

Description:

Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.

Treatment:

Drug: Glargine