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

NCT01336751 | Completed Phase 3

• 1 other identifier: HOE901_4021
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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%

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change from baseline in hemoglobin A1c (HbA1c) levels at week 24

  24 weeks

Secondary Outcomes (5)

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

  24 weeks

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

  24 weeks

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

  24 weeks

• Change from baseline in serum lipid values at week 24

  24 weeks

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

  24 weeks

Study Arms (2)

Insulin glargine

EXPERIMENTAL

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.

Drug: Insulin glargine

Lispro mix

ACTIVE COMPARATOR

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.

Drug: 75% insulin lispro protamine suspension and 25 % insulin lispro injection

Interventions

Insulin glargine DRUG

solution for subcutaneous injection

Also known as: Lantus

Insulin glargine

75% insulin lispro protamine suspension and 25 % insulin lispro injection DRUG

suspension for subcutaneous injection

Also known as: Humalog

Lispro mix

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Medical Affairs

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 18, 2011
• Study Start: July 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: April 18, 2011

Record last verified: 2011-04

Locations

US (1)