OPAL - Insulin Glulisine, Diabetes Mellitus

NCT ID: NCT00272012

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31

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 glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine.

Secondary objective:

Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of:

• Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint)
• Change of fasting plasma glucose (baseline to endpoint)
• Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint
• Insulin dose (rapid-acting, basal and total daily doses)
• Weight, body-mass index
• Hypoglycemic events
• Adverse events

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Insulin glulisine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Sanofi-aventis Germany

Principal Investigators

Wolfgang Landgraf, Dr.

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Berlin, , Germany

Countries

Germany

Other Identifiers

HMR1964A_3507

Identifier Type: -

Identifier Source: org_study_id