- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01336751
Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment
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 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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
New Jersey
-
Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Insulin glargine
Lantus (insulin glargine) administered subcutaneously 15 minutes before the evening meal for 24 weeks. The initial dosage was 10 units /day for 7 days. This was followed by titration every 7 days by increasing the dosage until control was established. Insulin dosages were increased according to a subject's glucose values determined by Self-monitoring blood glucose (SMBG). The starting dosage of metformin or sulfonylurea was the dosage the subject was taking when randomized. The dosage was to remain unchanged during the course of the study. The administration schedule was left to the discretion of the investigator. |
solution for subcutaneous injection
Other Names:
|
Active Comparator: Lispro mix
Humalog Mix 75/25 (lispro mix) administered subcutaneously 15 minutes before the evening meal for 24 weeks. The initial dosage was 10 units /day for 7 days. This was followed by titration every 7 days by increasing the dosage until control was established. Insulin dosages were increased according to a subject's glucose values determined by self-monitoring blood glucose (SMBG). The starting dosage of metformin or sulfonylurea was the dosage the subject was taking when randomized. The dosage was to remain unchanged during the course of the study. The administration schedule was left to the discretion of the investigator. |
suspension for subcutaneous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in hemoglobin A1c (HbA1c) levels at week 24
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 7.0% at Week 24
Time Frame: 24 weeks
|
24 weeks
|
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 8.0% at Week 24
Time Frame: 24 weeks
|
24 weeks
|
Change from baseline in fasting plasma glucose (FBG) values at week 24
Time Frame: 24 weeks
|
24 weeks
|
Change from baseline in serum lipid values at week 24
Time Frame: 24 weeks
|
24 weeks
|
Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Affairs, Sanofi
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Coagulants
- Heparin Antagonists
- Insulin
- Insulin, Globin Zinc
- Insulin Glargine
- Insulin Lispro
- Protamines
Other Study ID Numbers
- HOE901_4021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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