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OpenTrials
Completed

NCT Number: NCT00110370

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

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.

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Key information

Conditions

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

Age range

30 year–75 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 to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Manati, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lispro Mixture Therapy

Drug

Glargine Basal-Bolus Therapy

Drug

Primary outcomes

  1. To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior

  2. in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination

  3. with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal

  4. (A1C less than 7%) with once-daily insulin glargine in combination with OADs.

Secondary outcomes

  1. To test in both arms the following: frequency and incidence

  2. of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose,

  3. body weight, SAE's and study drug related AEs.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
May 9, 2005
Registry last updated
Nov 27, 2007

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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