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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336751
• Other study ID #: HOE901_4021
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2011
• Last updated: April 15, 2011
• Start date: July 2001
• Est. completion date: December 2002

Study information

• Verified date: April 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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%

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glargine
solution for subcutaneous injection
• 75% insulin lispro protamine suspension and 25 % insulin lispro injection
suspension for subcutaneous injection

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin A1c (HbA1c) levels at week 24		24 weeks	No
Secondary	Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values = 7.0% at Week 24		24 weeks	No
Secondary	Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values = 8.0% at Week 24		24 weeks	No
Secondary	Change from baseline in fasting plasma glucose (FBG) values at week 24		24 weeks	No
Secondary	Change from baseline in serum lipid values at week 24		24 weeks	No
Secondary	Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events		24 weeks	Yes