OPAL - Insulin Glulisine, Diabetes Mellitus

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: Insulin glulisine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00272012

HMR1964A_3507

Details and patient eligibility

About

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

Enrollment

396 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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