Type 2 Diabetes MellitusPhase 4GAUDINCT01461577
Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
A Phase 4 study testing INSULIN GLARGINE HOE 901 in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Japan.
Trial summary
Primary Objective: To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- INSULIN GLARGINE HOE 901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 4
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of aged ≥30 and ≤75 years with type 2 diabetes mellitus (T2DM)
- Hemoglobin A1c (glycosylated hemoglobin; HbA1c) levels measured at screening ≥7.5%
- Continuous treatment with stable doses of GLP-1 analogue for >3 months prior to enrollment (for patients also using oral anti-hyperglycemic drugs [OADs], continuous treatment with stable doses of OADs for >3 months prior to enrollment)
Who cannot join
- Inpatient with T2DM
- Diabetes other than T2DM (e.g. secondary to pancreatic disorders, drug or chemical agent intake)
- Fasting plasma glucose (FPG) levels <130mg/dL
- Body mass index (BMI) >28 kg/m2
- Patients using thiazolidinediones in the last 3 months prior to enrollment
- Use of any treatment for weight loss in the last 3 months prior to enrollment
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- Treatment with systemic corticosteroids within the 3 months prior to enrollment
- Patients using non-selective ß-blockers
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol
- Most recent ophthalmologic examination >6 months prior to enrollment
- Diabetic retinopathy with surgical treatment (last photocoagulation or vitrectomy) in the 3 months before enrollment or which may require surgical treatment
- Proliferative diabetic retinopathy or any other unstable rapidly progressive retinopathy
- Impaired renal function defined as, but not limited to, serum creatinine ≥1.3 mg/dL [males] or ≥1.2 mg/dL [females] or presence of macroproteinuria (>1 g/day)
- Active liver disease including hepatic cirrhosis, hepatic failure, and hepatitis or alanine transaminase (ALT) or aspartate aminotransferase (AST) >2 times upper limit or total bilirubin >1.5 times upper limit of normal (except in case of Gilbert's syndrome) at enrollment
- Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol
- Any medical condition that may have an influence on HbA1c rate
- Currently undergoing therapy for malignancy which may affect the study evaluation
- Use of any investigational product and/or device within the 2 months prior to enrollment
- History of ketoacidosis or hyperosmolar hyperglycemic state during the previous 12 months prior to enrollment
- History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months prior to enrollment
- History of congestive heart failure
- History of hypoglycemia unawareness or unexplained hypoglycemia during the previous 12 months prior to enrollment
- Hemoglobinopathy or hemolytic anemia, transfusion of blood or plasma products within 3 months prior to enrollment
- Known hypersensitivity / intolerance to insulin glargine or any of its excipients
- History of pancreatitis
- Pregnant or breast-feeding women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method)
- Shift workers or those who regularly work a night-time shift
- 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
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label, Single-arm, 24 Week Phase IV Study Evaluating the Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
Primary Objective:
- To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure.
Secondary Objective:
- To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.
Read the detailed description
1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- INSULIN GLARGINE HOE 901
- 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 GLARGINE HOE 901Drug
Pharmaceutical form:solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| insulin glargine | Experimental | Insulin glargine will be administered once a day, in the morning, at initial dose of 4 units/day. Titration of insulin dose will be performed referred with the median fasting plasma glucose value for the last 3 consecutive days according to the titration algorithm Receives: Drug: INSULIN GLARGINE HOE 901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
Measured: 24 weeks
Secondary outcomes (10)
Responder rate (HbA1c levels <7%) without severe hypoglycemia
Measured: 24 weeks
Responder rate (HbA1c levels <6.5% and <7%)
Measured: 24 weeks
Changes of fasting plasma glucose (FPG) levels from baseline
Measured: 24 weeks
Changes of beta cell marker: C-peptide from baseline
Measured: 24 weeks
Changes of Lipid profile: Lipid profile from baseline
Measured: 24 weeks
Weight change from baseline
Measured: 24 weeks
Total insulin dose (per kg body weight)
Measured: 24 weeks
Evaluation of patient's treatment satisfaction
Measured: 24 weeks
Number of patients with hypoglycemia
Measured: up to 24 weeks
Number of patients with treatment-emergent adverse events
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461577
- Sponsor's protocol ID
- LANTU_L_05477
- Other IDs
- U1111-1118-8753
- Acronym
- GAUDI
- Status last verified
- Jan 2013
- First submitted
- 26 Oct 2011
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, 24 Week Phase IV Study Evaluating the Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
- ClinicalTrials.gov ID
- NCT01461577
- Acronym / sponsor ID
- GAUDI / LANTU_L_05477
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Oct 2011 (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:
- To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure.
Secondary Objective:
- To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.
Detailed description
1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insulin glargine | Experimental | Drug: INSULIN GLARGINE HOE 901Insulin glargine will be administered once a day, in the morning, at initial dose of 4 units/day. Titration of insulin dose will be performed referred with the median fasting plasma glucose value for the last 3 consecutive days according to the titration algorithm |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of aged ≥30 and ≤75 years with type 2 diabetes mellitus (T2DM)
- Hemoglobin A1c (glycosylated hemoglobin; HbA1c) levels measured at screening ≥7.5%
- Continuous treatment with stable doses of GLP-1 analogue for >3 months prior to enrollment (for patients also using oral anti-hyperglycemic drugs [OADs], continuous treatment with stable doses of OADs for >3 months prior to enrollment)
Key exclusion criteria (28 listed)
- Inpatient with T2DM
- Diabetes other than T2DM (e.g. secondary to pancreatic disorders, drug or chemical agent intake)
- Fasting plasma glucose (FPG) levels <130mg/dL
- Body mass index (BMI) >28 kg/m2
- Patients using thiazolidinediones in the last 3 months prior to enrollment
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 GLARGINE HOE 901Pharmaceutical form:solution Route of administration: subcutaneous | Drug | insulin glargine |
Primary outcome
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
Time frame: 24 weeks
10 secondary outcomes
Responder rate (HbA1c levels <7%) without severe hypoglycemia
Time frame: 24 weeks
Responder rate (HbA1c levels <6.5% and <7%)
Time frame: 24 weeks
Changes of fasting plasma glucose (FPG) levels from baseline
Time frame: 24 weeks
Changes of beta cell marker: C-peptide from baseline
Time frame: 24 weeks
Changes of Lipid profile: Lipid profile from baseline
Time frame: 24 weeks
Weight change from baseline
Time frame: 24 weeks
Total insulin dose (per kg body weight)
Time frame: 24 weeks
Evaluation of patient's treatment satisfaction
Time frame: 24 weeks
Number of patients with hypoglycemia
Time frame: up to 24 weeks
Number of patients with treatment-emergent adverse events
Time frame: up to 24 weeks
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 30 Jan 2013.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing INSULIN GLARGINE HOE 901 in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Japan.
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 3 inclusion and 28 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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2013.