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OPAL - Insulin Glulisine, Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00272012
Recruitment Status : Completed
First Posted : January 4, 2006
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
Sanofi

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Insulin glulisine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2004
Actual Primary Completion Date : September 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in HbA1c. [ Time Frame: from baseline to study endpoint. ]

Secondary Outcome Measures :
  1. Change of pre-, 2 h postprandial and nocturnal blood glucose values [ Time Frame: 8-point profile ]
  2. Fasting blood glucose [ Time Frame: 8-point blood glucose profile values ]
  3. Responder rate HbA1c smaller 7 % [ Time Frame: at study endpoint ]
  4. Insulin dose [ Time Frame: rapid-acting, basal and total daily doses ]
  5. Weight, BMI [ Time Frame: study follow-up ]
  6. Hypoglycemic events [ Time Frame: study follow-up ]
  7. Adverse events. [ Time Frame: study follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272012


Locations
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Germany
Sanofi-Aventis
Berlin, Germany
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Wolfgang Landgraf, Dr. Sanofi

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Responsible Party: Heinz Riederer / Medical Director, Sanofi-aventis Germany
ClinicalTrials.gov Identifier: NCT00272012     History of Changes
Other Study ID Numbers: HMR1964A_3507
First Posted: January 4, 2006    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs