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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01336751
First received: April 14, 2011
Last updated: April 15, 2011
Last verified: April 2011
History of Changes
  Purpose

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%

Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Insulin glargine
Drug: 75% insulin lispro protamine suspension and 25 % insulin lispro injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in hemoglobin A1c (HbA1c) levels at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 7.0% at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 8.0% at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FBG) values at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in serum lipid values at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 212
Study Start Date: July 2001
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

 Drug: Insulin glargine
solution for subcutaneous injection
Other Name: Lantus
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.

 Drug: 75% insulin lispro protamine suspension and 25 % insulin lispro injection
suspension for subcutaneous injection
Other Name: Humalog

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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336751

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Affairs Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01336751     History of Changes
Other Study ID Numbers: HOE901_4021
Study First Received: April 14, 2011
Last Updated: April 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Glargine
Insulin
Metformin
Insulin, Long-Acting
 Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013