Diabetes Mellitus, Type 2Phase 3GINGERNCT00174668
Insulin Glulisine in Diabetes Mellitus, Type 2
A Phase 3 study testing Insulin Glulisine, Insulin Therapy and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 15 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glulisine, Insulin Therapy and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 15 sitesin 15 countries
- Study dates
- Nov 2004to Nov 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 15 countries.
15 sites in 15 countries
About this study
Official 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
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.
Read more
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glulisine, Insulin Therapy, Insulin Glargine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlulisineDrug
insulin glulisine 3 x daily (TID) subcutaneously 15 min before the start of a meal
Insulin TherapyDrug
NPH (70%) plus regular insulin or insulin aspart (30%)
Insulin GlargineDrug
1 x daily (OD) subcutaneously at any time (but every day at the same time) according to BG
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously Receives: Drug: Insulin Glulisine; Drug: Insulin Glargine |
| 2 | Active comparator | Two daily injection conventional insulin therapy Receives: Drug: Insulin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: From baseline to study endpoint
Self monitored BG (SMBG) values
Measured: During the whole treatment phase
Body weight/body mass index (BMI)
Measured: From baseline to study endpoint and all other visits
Fasting blood lipid profile
Measured: From baseline to study endpoint and all other visits
Urine albumin
Measured: From baseline to study endpoint and all other visits
Total daily insulin dose
Measured: From baseline to study endpoint
Secondary outcomes (4)
Adverse events
Measured: Throughout the study,
Standard laboratory tests
Measured: From baseline to study endpoint and all other visits
Vital signs
Measured: From baseline to study endpoint and all other visits
Physical examination
Measured: From baseline to study endpoint and all other visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valérie Pilorget, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174668
- Sponsor's protocol ID
- HMR1964A_3504
- Other IDs
- EUDRACT # : 2004-001287-49
- Acronym
- GINGER
- Status last verified
- Sep 2009
- First submitted
- 9 Sep 2005
- Last updated
- 15 Sep 2009
- Results posted
- No
Publications
Fritsche A, Hahn A, Landgraf W, Haring HU. Incidence of Hypoglycaemia in Patients with Type 2 Diabetes - A Subgroup Analysis from the GINGER study. Eur Endocrinol. 2013 Mar;9(1):1-3. doi: 10.17925/EE.2013.09.01.1. Epub 2013 Apr 4.
PubMed 30349602
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00174668
- Acronym / sponsor ID
- GINGER / HMR1964A_3504
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Nov 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin Glulisine, Drug: Insulin GlargineMealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously |
| 2 | Active comparator | Drug: Insulin TherapyTwo daily injection conventional insulin therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Glulisineinsulin glulisine 3 x daily (TID) subcutaneously 15 min before the start of a meal | Drug | 1 |
| Insulin TherapyNPH (70%) plus regular insulin or insulin aspart (30%) | Drug | 2 |
| Insulin Glargine1 x daily (OD) subcutaneously at any time (but every day at the same time) according to BG | Drug | 1 |
Primary outcome
HbA1c
Time frame: From baseline to study endpoint
Self monitored BG (SMBG) values
Time frame: During the whole treatment phase
Body weight/body mass index (BMI)
Time frame: From baseline to study endpoint and all other visits
Fasting blood lipid profile
Time frame: From baseline to study endpoint and all other visits
Urine albumin
Time frame: From baseline to study endpoint and all other visits
Total daily insulin dose
Time frame: From baseline to study endpoint
4 secondary outcomes
Adverse events
Time frame: Throughout the study,
Standard laboratory tests
Time frame: From baseline to study endpoint and all other visits
Vital signs
Time frame: From baseline to study endpoint and all other visits
Physical examination
Time frame: From baseline to study endpoint and all other visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
- Derived from this study: PubMed 30349602Fritsche A, Hahn A, Landgraf W, Haring HU. Incidence of Hypoglycaemia in Patients with Type 2 Diabetes - A Subgroup Analysis from the GINGER study. Eur Endocrinol. 2013 Mar;9(1):1-3. doi: 10.17925/EE.2013.09.01.1. Epub 2013 Apr 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Pilorget, MD study director
Sanofi
15 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Glulisine, Insulin Therapy and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 15 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Australia, Belgium, Czechia, France, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: From baseline to study endpoint). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00174668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.