Back to resultsLantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Insulin glargine
75% insulin lispro protamine suspension and 25 % insulin lispro injection
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insulin glargine
Lispro mix
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline in hemoglobin A1c (HbA1c) levels at week 24
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01336751
Brief Title
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
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin glargine
Arm Type
Experimental
Arm Description
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.
Arm Title
Lispro mix
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Other Intervention Name(s)
Lantus
Intervention Description
solution for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
75% insulin lispro protamine suspension and 25 % insulin lispro injection
Other Intervention Name(s)
Humalog
Intervention Description
suspension for subcutaneous injection
Primary Outcome Measure Information:
Title
Change from baseline in hemoglobin A1c (HbA1c) levels at week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 7.0% at Week 24
Time Frame
24 weeks
Title
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 8.0% at Week 24
Time Frame
24 weeks
Title
Change from baseline in fasting plasma glucose (FBG) values at week 24
Time Frame
24 weeks
Title
Change from baseline in serum lipid values at week 24
Time Frame
24 weeks
Title
Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Affairs
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment
We'll reach out to this number within 24 hrs