Status:
COMPLETED
OPAL - Insulin Glulisine, Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary objective: The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin gla...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Type 2 Diabetes mellitus, previously treated with combination therapy of insulin glargine + OAD (maximal tolerated dose / approved in combination with insulin according to local SPCs (Summary of Product Characteristics), not including use of a-glucosidase inhibitors) for at least 3 months
- Pre-screening HbA1c value greater/equal 7% - smaller/equal 9%
- FBG (Fasting Blood Glucose) smaller/equal 120 mg/dl (6.6 mmol/l)
- Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
- Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home
- Exclusion criteria:
- More than two FBG greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit II
- Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation)
- Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
- Known impaired hepatic and renal function
- History of drug or alcohol abuse
- History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine formulation
- Treatment with any investigational drug in the last month before visit I
- Pregnant or breast-feeding women, or women planning to become pregnant during the study
- Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- Night shift workers if they are unable to comply with the treatment regimen
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT00272012
Start Date
July 1 2004
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis
Berlin, Germany