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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT01336751

Public ClinicalTrials.gov record NCT01336751. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Lantus® (Insulin Glargine[rDNA Origin] Injection) vs Humalog® Mix 75/25 (75% Insulin Lispro Protamine Suspension and 25% Insulin Lispro Injection) as add-on Therapy in Type 2 Diabetes Patients Failing Sulfonylurea and Glucophage (Metformin) Combination Treatment: a Randomized, Open, Parallel Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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%

Study identification

NCT ID
NCT01336751
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
212 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 79 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2001
Primary completion
Nov 30, 2002
Completion
Nov 30, 2002
Last update posted
Apr 17, 2011

2001 – 2002

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Sanofi-Aventis Administrative Office Bridgewater New Jersey

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01336751, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 17, 2011 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01336751 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →