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Completed

NCT Number: NCT00551538

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lispro mix 75/25

Drug

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

Glargine

Drug

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

Primary outcomes

  1. 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 outcomes

  1. HbA1c

    Time frame: At end of treatment arm or 3 months.

  2. 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.

  3. 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.

  4. 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.

  5. The mean amplitude of glycemic excursion

    Time frame: At end of treatment arm or 3 months.

  6. Concentration of plasma triglycerides and free fatty acids

    Time frame: At end of treatment arm or 3 months.

  7. 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.

  8. Insulin dose and body weight

    Time frame: At end of treatment arm or 3 months.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Oct 31, 2007
Registry last updated
Oct 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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