Clinical trial NCT01336751: Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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%

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in hemoglobin A1c (HbA1c) levels at week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 7.0% at Week 24
timeFrame: 24 weeks
measure: Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 8.0% at Week 24
timeFrame: 24 weeks
measure: Change from baseline in fasting plasma glucose (FBG) values at week 24
timeFrame: 24 weeks
measure: Change from baseline in serum lipid values at week 24
timeFrame: 24 weeks
measure: Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: Medical Affairs
role: STUDY_DIRECTOR
References: