Type 2 DiabetesPhase 4MalbecNCT00627471
Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)
A Phase 4 study testing Insulin Glargine in people with Type 2 Diabetes, run by Sanofi at 1 site in Argentina.
Trial summary
To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice. Read more about this study
- Who is it for?
- Ages 21 to 74 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Insulin Glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteArgentina
- Study dates
- Jan 2008to Mar 2009
- 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 21 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes.
- Patients in treatment with OADs (one or more) for at least 1 year who failed metabolic control (HbA1c > 8% and < 11%).
- FBG > 130 mg/dl and < 240 mg/dl.
- BMI < 40 kg/m2 and >25 kg/m2.
- Ability and willingness to follow a tight anti-diabetic therapy and to perform SMBG controls.
Who cannot join
- C peptide < 0.30 nmol/l.
- Unexplained weight loss of more than 10% of body weight in the last 6 months.
- Pregnant women or women with the intention of becoming pregnant.
- Women with childbearing potential who will not use contraceptive protection.
- Breastfeeding women.
- Patients using or that have used rapid or ultra-rapid acting insulins; except for those patients that have used rapid or ultra-rapid insulins during intercurrences such as AMI, severe infection or surgery.
Show all 15Show fewer
- Renal impairment defined as serum creatinine >1.4 mg/dl in women and >1.5 mg/dl in men.
- Hepatic impairment defined as GPT or GOT above 2x the normal threshold.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (non selective beta blockers and systemic corticosteroids).
- History of drug or alcoholic abuse.
- Diabetic retinopathy with surgical treatment in the 3 months prior to study entry or which may require surgical treatment within 6 months of study entry.
- Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological, oncologic or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, at the discretion of the investigator.
- Evidence of an uncooperative attitude, including poor compliance to any anti- diabetic treatment.
- Known hypersensitivity to insulin glargine.
- 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 24 Weeks, Randomized, 2 Arms, Controlled, Multi-centre, National, Open-labeled, Parallel Study in Insulin naïve Patients With Type 2 Diabetes to Compare a Lantus Titration Algorithm vs. Physician's Standard Practice
To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice.
To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice.
Read more
To compare the percentage of patients achieving HbA1c< 7% in each treatment group.
To compare hypoglycaemic events (minor, severe and nocturnal) between groups.
To compare average insulin dose between groups.
To compare PRO (patients' reported outcomes) between groups.
To compare mean changes in body weight between treatment groups.
- Conditions
- Type 2 Diabetes
- Being tested
- 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 GlargineDrug
For the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG.
Insulin GlargineDrug
In the group following the algorithm, fasting SMBG will be asked 3 times a week until FBG<100 mg/dl is achieved. Afterwards, 1 fasting SMBG will be asked weekly. Pre-prandial SMBG will be performed at the discretion of the physician.
For the group following the algorithm, during the titration period, weekly telephone contacts will be required and a minimum of 4 visits to the clinic.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm. Receives: Drug: Insulin Glargine |
| B | Active comparator | This is the control group, following the physician's standard practice. Receives: Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in HbA1c (efficacy)
Measured: 6 months
Secondary outcomes (1)
Minor, severe and nocturnal Hypoglycaemic events (safety)
Measured: from the begining of the treatment up to 5 days after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2009
Why it stopped: Low recruitment in spite of strategies implemented
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cristian von Schulz-Hausmann, Study director, Sanofi-aventis administrative office Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627471
- Sponsor's protocol ID
- LANTU_L_02936
- Acronym
- Malbec
- Status last verified
- Jun 2010
- First submitted
- 22 Feb 2008
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Weeks, Randomized, 2 Arms, Controlled, Multi-centre, National, Open-labeled, Parallel Study in Insulin naïve Patients With Type 2 Diabetes to Compare a Lantus Titration Algorithm vs. Physician's Standard Practice
- ClinicalTrials.gov ID
- NCT00627471
- Acronym / sponsor ID
- Malbec / LANTU_L_02936
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment in spite of strategies implemented
- Enrolment
- 9 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- First posted
- 3 Mar 2008 (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.
To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice.
To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice.
To compare the percentage of patients achieving HbA1c< 7% in each treatment group.
To compare hypoglycaemic events (minor, severe and nocturnal) between groups.
To compare average insulin dose between groups.
To compare PRO (patients' reported outcomes) between groups.
To compare mean changes in body weight between treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Insulin GlargineThis group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm. |
| B | Active comparator | Drug: Insulin GlargineThis is the control group, following the physician's standard practice. |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type 2 diabetes.
- Patients in treatment with OADs (one or more) for at least 1 year who failed metabolic control (HbA1c > 8% and < 11%).
- FBG > 130 mg/dl and < 240 mg/dl.
- BMI < 40 kg/m2 and >25 kg/m2.
- Ability and willingness to follow a tight anti-diabetic therapy and to perform SMBG controls.
Key exclusion criteria (15 listed)
- C peptide < 0.30 nmol/l.
- Unexplained weight loss of more than 10% of body weight in the last 6 months.
- Pregnant women or women with the intention of becoming pregnant.
- Women with childbearing potential who will not use contraceptive protection.
- Breastfeeding women.
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 GlargineFor the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG. | Drug | B |
| Insulin GlargineIn the group following the algorithm, fasting SMBG will be asked 3 times a week until FBG<100 mg/dl is achieved. Afterwards, 1 fasting SMBG will be asked weekly. Pre-prandial SMBG will be performed at the discretion of the physician. For the group following the algorithm, during the titration period, weekly telephone contacts will be required and a minimum of 4 visits to the clinic. | Drug | A |
Primary outcome
Mean difference in HbA1c (efficacy)
Time frame: 6 months
1 secondary outcome
Minor, severe and nocturnal Hypoglycaemic events (safety)
Time frame: from the begining of the treatment up to 5 days after the end of the study
Results and safety
The study was stopped early (reason given: Low recruitment in spite of strategies implemented). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Cristian von Schulz-Hausmann study director
Sanofi-aventis administrative office Argentina
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 in people with Type 2 Diabetes, run by Sanofi at 1 site in Argentina.
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 5 inclusion and 15 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 2 Jun 2010. 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 Argentina. 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: Low recruitment in spite of strategies implemented). 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?
Mean difference in HbA1c (efficacy) (time frame: 6 months). 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 2 Jun 2010.