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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00110370

Enrollment

300

Registered

2005-05-09

Start date

2004-04-30

Completion date

2006-04-30

Last updated

2007-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

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.

Interventions

DRUGLispro Mixture Therapy

DRUGGlargine Basal-Bolus Therapy

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026