Insulin Glulisine in Diabetes Mellitus, Type 2 (GINGER)

September 14, 2009 updated by: Sanofi

52-week, Open, Randomized, Multinational, Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-injection Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control Pretreated With a Two-injection Conventional Insulin Therapy

Primary objective:

The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.

Secondary objectives:

Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/treatment satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • North Ryde, Australia
        • Sanofi-Aventis
  • Belgium
      • Brussels, Belgium
        • Sanofi-Aventis
  • Czech Republic
      • Prague, Czech Republic
        • Sanofi-Aventis
  • France
      • Paris, France
        • Sanofi-Aventis
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis
  • Italy
      • Milan, Italy
        • Sanofi-Aventis
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis
  • Poland
      • Warsaw, Poland
        • Sanofi-Aventis
  • Portugal
      • Porto Salvo, Portugal
        • Sanofi-Aventis
  • Romania
      • Bucharest, Romania
        • Sanofi-Aventis
  • Slovakia
      • Bratislava, Slovakia
        • Sanofi-Aventis
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis
  • Sweden
      • Stockholm, Sweden
        • Sanofi-Aventis
  • Switzerland
      • Meyrin, Switzerland
        • Sanofi-Aventis
  • United Kingdom
      • Guildford, United Kingdom
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

Subjects meeting all of the following criteria will be considered for enrollment into the study:

  • Type 2 diabetes mellitus, as defined by the American Diabetes Association for at least five years, treated with insulin for at least 6 months (no history of ketoacidosis).
  • HbA1c between 7.5% and 11.0%, inclusive at both pre-screening and pre-randomization (week -2).
  • For at least 3 months prior to week -8 visit, subjects must have been on a stable insulin regimen with two daily s.c. injections of premixed insulin: NPH plus regular insulin or NPH plus rapid acting insulin (insulin lispro or insulin aspart) in a mixture of 70/30 or 75/25. "Stable" means no change in regimen and no more than 30 % change in dose. Optionally, the subject can have been treated in addition with metformin according to its current official product information leaflet, treatment with other oral blood glucose lowering drugs is not allowed.
  • Documentation of a full ophthalmologic exam (incl. fundoscopy)during the 6 months prior to randomization.
  • Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years). Women of childbearing potential must not be 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.
  • Willing and able to perform specified home blood glucose monitoring and to otherwise comply with study protocol requirements.
  • Willing to change from a twice daily insulin regimen to a regimen requiring four daily insulin injections.
  • Provision of signed and dated informed consent prior to any study procedures."Prescreening" informed consent, obtained in writing for all subjects, may be used during screening, but full study-specific informed consent must be obtained in writing for all subjects after any post-screening procedures.

Exclusion criteria :

Subjects presenting with any of the following will not be included in the study:

  • Two or more severe hypoglycemic episodes within the past 3 months, or any hospitalization or emergency room visit due to poor diabetic control within the past 3 months prior to randomization.
  • History of hypoglycemia unawareness.
  • Impaired hepatic function, as shown by, but not limited to, ALAT (SGPT) or ASAT (SGOT) above 2x the upper limit of normal as measured at visit 1.
  • Impaired renal function, as shown by, but not limited to, serum creatinine > 177 mmol/l (> 2 mg/dl) as measured at visit 1 (if no lower values due to individual metformin intake are required) or current renal dialysis.
  • Body mass index (BMI) > 38 kg/m2.
  • Any other clinically significant abnormalities on screening laboratory evaluation (unless discussed with the monitor and approved by the study management).
  • 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) during the study.
  • History of hypersensitivity to insulin or insulin analogues or any of the excipients in the HMR 1964 formulation.
  • Donation of blood or transfusion during the 2 months prior to the screening visit.
  • Pregnant or lactating women, or women planning to become pregnant during the study.
  • Treatment with any investigational drug in the last month before visit 1 (screening).
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematologic or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
  • Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
  • History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse.
  • Night shift workers.
  • Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
  • Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Mealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously
Drug: Insulin Glulisine
insulin glulisine 3 x daily (TID) subcutaneously 15 min before the start of a meal
Drug: Insulin Glargine
1 x daily (OD) subcutaneously at any time (but every day at the same time) according to BG
Active Comparator: 2
Two daily injection conventional insulin therapy
Drug: Insulin Therapy
NPH (70%) plus regular insulin or insulin aspart (30%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: From baseline to study endpoint
From baseline to study endpoint
Self monitored BG (SMBG) values
Time Frame: During the whole treatment phase
During the whole treatment phase
Body weight/body mass index (BMI)
Time Frame: From baseline to study endpoint and all other visits
From baseline to study endpoint and all other visits
Fasting blood lipid profile
Time Frame: From baseline to study endpoint and all other visits
From baseline to study endpoint and all other visits
Urine albumin
Time Frame: From baseline to study endpoint and all other visits
From baseline to study endpoint and all other visits
Total daily insulin dose
Time Frame: From baseline to study endpoint
From baseline to study endpoint

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Throughout the study,
Throughout the study,
Standard laboratory tests
Time Frame: From baseline to study endpoint and all other visits
From baseline to study endpoint and all other visits
Vital signs
Time Frame: From baseline to study endpoint and all other visits
From baseline to study endpoint and all other visits
Physical examination
Time Frame: From baseline to study endpoint and all other visits
From baseline to study endpoint and all other visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR1964A_3504
  • EUDRACT # : 2004-001287-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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