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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00174668




Registration number
NCT00174668
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
15/09/2009

Titles & IDs
Public title
Insulin Glulisine in Diabetes Mellitus, Type 2
Scientific title
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
Secondary ID [1] 0 0
EUDRACT # : 2004-001287-49
Secondary ID [2] 0 0
HMR1964A_3504
Universal Trial Number (UTN)
Trial acronym
GINGER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin Glulisine
Treatment: Drugs - Insulin Therapy
Treatment: Drugs - Insulin Glargine

Experimental: 1 - Mealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously

Active Comparator: 2 - Two daily injection conventional insulin therapy


Treatment: Drugs: Insulin Glulisine
insulin glulisine 3 x daily (TID) subcutaneously 15 min before the start of a meal

Treatment: Drugs: Insulin Therapy
NPH (70%) plus regular insulin or insulin aspart (30%)

Treatment: Drugs: Insulin Glargine
1 x daily (OD) subcutaneously at any time (but every day at the same time) according to BG
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
From baseline to study endpoint
Primary outcome [2] 0 0
Self monitored BG (SMBG) values
Timepoint [2] 0 0
During the whole treatment phase
Primary outcome [3] 0 0
Body weight/body mass index (BMI)
Timepoint [3] 0 0
From baseline to study endpoint and all other visits
Primary outcome [4] 0 0
Fasting blood lipid profile
Timepoint [4] 0 0
From baseline to study endpoint and all other visits
Primary outcome [5] 0 0
Urine albumin
Timepoint [5] 0 0
From baseline to study endpoint and all other visits
Primary outcome [6] 0 0
Total daily insulin dose
Timepoint [6] 0 0
From baseline to study endpoint
Secondary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
Throughout the study,
Secondary outcome [2] 0 0
Standard laboratory tests
Timepoint [2] 0 0
From baseline to study endpoint and all other visits
Secondary outcome [3] 0 0
Vital signs
Timepoint [3] 0 0
From baseline to study endpoint and all other visits
Secondary outcome [4] 0 0
Physical examination
Timepoint [4] 0 0
From baseline to study endpoint and all other visits

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
311
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Prague
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Italy
State/province [5] 0 0
Milan
Country [6] 0 0
Netherlands
State/province [6] 0 0
Gouda
Country [7] 0 0
Poland
State/province [7] 0 0
Warsaw
Country [8] 0 0
Portugal
State/province [8] 0 0
Porto Salvo
Country [9] 0 0
Romania
State/province [9] 0 0
Bucharest
Country [10] 0 0
Slovakia
State/province [10] 0 0
Bratislava
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Sweden
State/province [12] 0 0
Stockholm
Country [13] 0 0
Switzerland
State/province [13] 0 0
Meyrin
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00174668
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Valérie Pilorget, MD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries