Status:
COMPLETED
Insulin Glulisine in Type 2 Diabetic Patients
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic...
Eligibility Criteria
Inclusion
- Diabetes Mellitus, Type 2
- 25 \< BMI \< 45 kg/m²
- 7,5% \< HbA1c \< 9%
- Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months
Exclusion
- Type 1 diabetes mellitus
- Treatment with OADs only
- Treatment with thiazolidinediones, with exenatide or with pramlintide
- Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
- Active proliferative diabetic retinopathy,
- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
- Breast-feeding
- History of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
- Treatment with systemic corticosteroids in the 3 months prior to study entry
- Treatment with any investigational product in the 2 months prior to study entry
- Previous treatment with insulin glulisine
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- Impaired hepatic function
- Impaired renal function
- History of drug or alcohol abuse
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00360698
Start Date
July 1 2006
End Date
August 1 2008
Last Update
August 8 2011
Active Locations (3)
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1
Sanofi-aventis
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis
Moscow, Russia
3
Sanofi-aventis
Guildford, United Kingdom