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Search / Trial NCT01336751

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

Launched by SANOFI · Apr 15, 2011

Trial Information

Current as of June 06, 2025

Completed

Keywords

ClinConnect Summary

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.

Gender

ALL

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.

About Sanofi

Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.

Locations

Bridgewater, New Jersey, United States

Patients applied

0 patients applied

Trial Officials

Medical Affairs

Study Director

Sanofi

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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