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Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment

NCT01336751 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2011-04-18

No results posted yet for this study

Summary

Study Primary Objectives:

To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin.

Study Secondary Objectives :

To compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro:

* Incidence of hypoglycemia
* Change in weight
* Change in serum lipid profile
* Percentage of subjects achieving A1C levels ≤7%

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin glargine

solution for subcutaneous injection

DRUG

75% insulin lispro protamine suspension and 25 % insulin lispro injection

suspension for subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Medical Affairs · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2002-12-31
Completion
2002-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336751 on ClinicalTrials.gov