OPAL - Insulin Glulisine, Diabetes Mellitus - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00272012

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: Insulin glulisine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Insulin Glulisine Given as a Single Injection at Breakfast + Insulin Glargine+OAD (Oral Antidiabetic Drug) vs Insulin Glulisine Given as a Single Injection at Main Meal+Insulin Glargine+OAD in Type 2 Diabetic Patients for Which Glycemic Control is Suboptimal Using Insulin Glargine+ OAD Alone

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine Insulin glulisine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change in HbA1c. [ Time Frame: from baseline to study endpoint. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of pre-, 2 h postprandial and nocturnal blood glucose values [ Time Frame: 8-point profile ] [ Designated as safety issue: No ]
Fasting blood glucose [ Time Frame: 8-point blood glucose profile values ] [ Designated as safety issue: No ]
Responder rate HbA1c smaller 7 % [ Time Frame: at study endpoint ] [ Designated as safety issue: No ]
Insulin dose [ Time Frame: rapid-acting, basal and total daily doses ] [ Designated as safety issue: No ]
Weight, BMI [ Time Frame: study follow-up ] [ Designated as safety issue: No ]
Hypoglycemic events [ Time Frame: study follow-up ] [ Designated as safety issue: Yes ]
Adverse events. [ Time Frame: study follow-up ] [ Designated as safety issue: Yes ]

Enrollment:	396
Study Start Date:	July 2004
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272012

Locations

Germany
Sanofi-aventis
Berlin, Germany

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Wolfgang Landgraf, Dr.

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-aventis Germany ( Heinz Riederer / Medical Director )
Study ID Numbers:	HMR1964A/3507
Study First Received:	January 2, 2006
Last Updated:	February 18, 2008
ClinicalTrials.gov Identifier:	NCT00272012 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Hypoglycemic Agents
Insulin glulisine
Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Insulin glulisine
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 01, 2009