OPAL - Insulin Glulisine, Diabetes Mellitus

NCT00272012 | Completed Phase 3

• 1 other identifier: HMR1964A_3507
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c.

  from baseline to study endpoint.

Secondary Outcomes (7)

• Change of pre-, 2 h postprandial and nocturnal blood glucose values

  8-point profile

• Fasting blood glucose

  8-point blood glucose profile values

• Responder rate HbA1c smaller 7 %

  at study endpoint

• Insulin dose

  rapid-acting, basal and total daily doses

• Weight, BMI

  study follow-up

Interventions

Insulin glulisine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Berlin, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wolfgang Landgraf, Dr.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 2, 2006
• First Posted: January 4, 2006
• Study Start: July 1, 2004
• Primary Completion: September 1, 2006
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

DE (1)