OPAL - Insulin Glulisine, Diabetes Mellitus

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

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