Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00110370
First received: May 6, 2005
Last updated: November 26, 2007
Last verified: November 2007
  Purpose

The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Lispro Mixture Therapy
Drug: Glargine Basal-Bolus Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
  • in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination
  • with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal
  • (A1C less than 7%) with once-daily insulin glargine in combination with OADs.

Secondary Outcome Measures:
  • To test in both arms the following: frequency and incidence
  • of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose,
  • body weight, SAE's and study drug related AEs.

Estimated Enrollment: 300
Study Start Date: April 2004
Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have type 2 diabetes.
  • Must be 30-75 years of age at the time of Visit 1.
  • Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
  • Must be on at least 30 units of glargine per day at enrollment.
  • Have an A1C between 7.5% and 12.0% at Visit 1.

Exclusion Criteria:

  • Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
  • Must not have more than one episode of severe hypoglycemia in the last 6 months.
  • Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
  • Must not have congestive heart failure that requires medications.
  • Must not have had a kidney transplant or currently receiving dialysis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00110370

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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 from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00110370     History of Changes
Other Study ID Numbers: 9057, F3Z-US-IOOQ
Study First Received: May 6, 2005
Last Updated: November 26, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014