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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin glargine (Drug); 75% insulin lispro protamine suspension and 25 % insulin lispro injection (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Medical Affairs, Study Director, Affiliation: Sanofi


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%

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in hemoglobin A1c (HbA1c) levels at week 24

Secondary outcome:

Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 7.0% at Week 24

Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 8.0% at Week 24

Change from baseline in fasting plasma glucose (FBG) values at week 24

Change from baseline in serum lipid values at week 24

Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events

Detailed description: The planned duration of enrollment is 6 months. The study consists of 2 weeks screening phase and a study period that was planned to be 24 weeks.


Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.


Inclusion Criteria:

- Patients must have given their signed informed consent.

- Males or females between 18 and 79 years of age.

- Diagnosis of type 2 diabetes mellitus for at least one year.

- Patients must have had continuous oral hypoglycemic treatment for at least three

months using dosing of: at least half maximally labeled dose of sulfonylurea + at least 1000 mg metformin daily.

- HBA1C ≥ 8 % and ≤11 %, inclusive, as measured at screening (visit 1).

- Patients must have BMI of > 25 kg/m2 at baseline

- Willingness to accept, and demonstrate ability to inject insulin glargine or 75%

insulin lispro protamine suspension and 25% insulin lispro injection therapy.

- Ability and willingness to perform SMBG profiles using a plasma glucose meter at

least twice a day.

- Patients must be able to understand and willing to adhere to and be compliant with

the study protocol Exclusion Criteria:

- Patients, who have had stroke, MI, coronary artery bypass graft (CABG), percutaneous

transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.

- Patients with congestive heart failure requiring pharmacological treatment.

- Patients on non-selective beta blockers (including ocular).

- Patients with impaired renal function, as shown by but not limited to serum

creatinine ≥ 1. 5 mg/dl (133μmol/L) for males, or ≥ 1. 4 mg/dl (124 μmol/L) for females.

- Patients with acute infections.

- Patients with diagnosis of dementia.

- Treatment with systemic steroids or large doses of inhaled steroids.

- Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis.

- Patients with planned radiological examinations requiring administration of

contrasting agents.

- Clinical evidence of active liver disease, or serum ALT 2. 5 times the upper limit of

the normal range.

- Patients with history of hypoglycemia unawareness.

- Pregnant or lactating females.

- Failure to use adequate contraception (women of current reproductive potential only).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations and Contacts

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States
Additional Information

Starting date: July 2001
Last updated: April 15, 2011

Page last updated: August 23, 2015

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