Diabetes Mellitus, Type 2Phase 4NCT01081938
Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition
A Phase 4 study testing INSULIN GLARGINE and INSULIN GLULISINE in people with Diabetes Mellitus, Type 2, run by Sanofi at 10 sites in Brazil.
Trial summary
Primary Objective: 1- Proportion of patients with mean daily glycemia <140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale. Secondary Objective: 1. Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- INSULIN GLARGINE and INSULIN GLULISINE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 10 sitesBrazil
- Study dates
- Feb 2010to Feb 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with type 2 diabetes that will need enteral nutrition with carbohydrate content.
- Glycemia >140mg/dL and < 400mg/dL at admission on the ward.
- Informed consent (patient or legally authorized representative)
Who cannot join
- Hypersensibility to insulin glargine or glulisine, or any other component of the insulin formulation.
- Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months.
- History of diabetic ketoacidosis or hyperosmolar hyperglycaemic state or ketonuria.
- Subjects with conditions that are expected to need surgery or intensive care unit (ICU)admission based on discussions with the treatment team and attending physician.
- Pregnancy.
- Severe hepatic disease or active hepatitis.
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- Cardiac failure class III or IV (Classification de la New York Heart Association:NYHA).
- Diagnosed advanced autonomic neuropathy.
- Diagnosed cancer.
- Active infection.
- Current therapy with steroids.
- Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
- 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
10 sites in 1 country.
10 sites in 1 country
Brazil10 sites
Sanofi-Aventis Investigational Site Number 076-007
Belo Horizonte, 30150-120
Sanofi-Aventis Investigational Site Number 076-011
Curitiba, 80420-011
Sanofi-Aventis Investigational Site Number 076-005
Joinville
Sanofi-Aventis Investigational Site Number 076-001
Porto Alegre, 90035-001
Sanofi-Aventis Investigational Site Number 076-004
Porto Alegre, 90035-003
Sanofi-Aventis Investigational Site Number 076-006
São José do Rio Preto, 15090-000
Sanofi-Aventis Investigational Site Number 076-010
São Paulo, 01232-010
Sanofi-Aventis Investigational Site Number 076-008
São Paulo, 01308-050
Sanofi-Aventis Investigational Site Number 076-003
São Paulo, 01323-020
Sanofi-Aventis Investigational Site Number 076-009
São Paulo, 01323-900
About this study
Official title: National, Phase IV, Multicentric, Open Label, Comparative Study to Evaluate the Efficacy and Safety of Insulin Glargine Plus Glulisine and Sliding Scale Plus Glulisine in Hospitalized Patients With Diabetes Metabolism Type II Under Enteral Nutrition.
Primary Objective:
1- Proportion of patients with mean daily glycemia <140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale.
Secondary Objective:
- Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period.
- Incidence of hypoglycemia (<60mg/dL and < 40mg/dL) during the treatment period.
- Incidence of severe hyperglycemia (>400mg/dL) during the treatment period.
- Total dose of insulin and correction dose in each group.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- INSULIN GLARGINE, INSULIN GLULISINE
- 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 GLARGINEDrug
Pharmaceutical form: Lantus® (100 U/ml)
Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device.
Dose regimen: Single daily dose of Insulin Glargine
INSULIN GLULISINEDrug
Pharmaceutical form: Apidra® (100 U/ml)
Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device
Dose regimen:
Arm1: Every 6 hours Arm2: several daily dose according to sliding scale of Insulin Glargine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Insulin Glargine + Insulin Glulisine Receives: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE |
| 2 | Active comparator | Insulin Glulisine Receives: Drug: INSULIN GLULISINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic parameters assessment
Measured: During the period of 7 Days of treatment
Secondary outcomes (2)
Incidence of moderate and severe hyperglycemia
Measured: During the period of 7 Days of treatment
Incidence of symptomatic, nocturnal and severe hypoglycemias
Measured: During the period of 7 Days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT01081938
- Sponsor's protocol ID
- LANTU_L_04572
- Other IDs
- U1111-1116-9777
- Status last verified
- Mar 2012
- First submitted
- 4 Mar 2010
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Phase IV, Multicentric, Open Label, Comparative Study to Evaluate the Efficacy and Safety of Insulin Glargine Plus Glulisine and Sliding Scale Plus Glulisine in Hospitalized Patients With Diabetes Metabolism Type II Under Enteral Nutrition.
- ClinicalTrials.gov ID
- NCT01081938
- Acronym / sponsor ID
- LANTU_L_04572
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges
- Enrolment
- 15 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Mar 2010 (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:
1- Proportion of patients with mean daily glycemia <140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale.
Secondary Objective:
- Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period.
- Incidence of hypoglycemia (<60mg/dL and < 40mg/dL) during the treatment period.
- Incidence of severe hyperglycemia (>400mg/dL) during the treatment period.
- Total dose of insulin and correction dose in each group.
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 GLARGINE, Drug: INSULIN GLULISINEInsulin Glargine + Insulin Glulisine |
| 2 | Active comparator | Drug: INSULIN GLULISINEInsulin Glulisine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women with type 2 diabetes that will need enteral nutrition with carbohydrate content.
- Glycemia >140mg/dL and < 400mg/dL at admission on the ward.
- Informed consent (patient or legally authorized representative)
Key exclusion criteria (13 listed)
- Hypersensibility to insulin glargine or glulisine, or any other component of the insulin formulation.
- Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months.
- History of diabetic ketoacidosis or hyperosmolar hyperglycaemic state or ketonuria.
- Subjects with conditions that are expected to need surgery or intensive care unit (ICU)admission based on discussions with the treatment team and attending physician.
- Pregnancy.
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 GLARGINEPharmaceutical form: Lantus® (100 U/ml) Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device. Dose regimen: Single daily dose of Insulin Glargine | Drug | 1 |
| INSULIN GLULISINEPharmaceutical form: Apidra® (100 U/ml) Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device Dose regimen: Arm1: Every 6 hours Arm2: several daily dose according to sliding scale of Insulin Glargine | Drug | 1, 2 |
Primary outcome
Glycaemic parameters assessment
Time frame: During the period of 7 Days of treatment
2 secondary outcomes
Incidence of moderate and severe hyperglycemia
Time frame: During the period of 7 Days of treatment
Incidence of symptomatic, nocturnal and severe hypoglycemias
Time frame: During the period of 7 Days of treatment
Results and safety
The study was stopped early (reason given: Recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
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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
10 sites 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 and INSULIN GLULISINE in people with Diabetes Mellitus, Type 2, run by Sanofi at 10 sites in Brazil.
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 13 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: stopped early, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. 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 was stopped early (reason given: Recruitment challenges). Results are not available in the source record.
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?
Glycaemic parameters assessment (time frame: During the period of 7 Days of treatment). 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 27 Mar 2012.