Diabetes Mellitus, Type 2Phase 4LANTITNCT00701831
Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control
A Phase 4 study testing Insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Turkey (Türkiye).
Trial summary
Primary objective: To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients Secondary objectives: To assess the forced titration on physician and patient satisfaction To evaluate the impact of training tools by means of patient profile 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2008to Oct 2010
- 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
- T2 insulin naïve patients
- Patients whom their physician is considering initiation of Lantus treatment
- Poor glycemic control 7,5 %10 %
- T2 treatment with OADs more than 3 months
- BMI<40 kg/m2
Who cannot join
- Impaired renal function (Cr>2mg/dl or current renal dialysis)
- Acute or chronic metabolic acidosis
- Active liver disease or serum ALT or AST >2,5 than normal
- History of hypoglycemia unawareness
- Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
- Pregnancy, breast feeding
- 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: Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients
Primary objective:
- To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients
Secondary objectives:
- To assess the forced titration on physician and patient satisfaction
- To evaluate the impact of training tools by means of patient profile
- Conditions
- Diabetes Mellitus, Type 2
- 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
The dose is titrated according to patient needs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Insulin glargine Receives: Drug: Insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c, FBG
Measured: after treatment end (6 months)
Final dose
Measured: after treatment end (6 months)
Number of dose adjustment
Measured: after treatment end (6 months)
Time to dose titration
Measured: after treatment end (6 months)
Secondary outcomes (4)
Hypoglycemia
Measured: after treatment end (6 months)
Noctural hypoglycemia
Measured: after treatment end (6 months)
DTSQ
Measured: after treatment end (6 months)
Physician Satisfaction Questionnaire
Measured: after treatment end (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2010
- Study completionOct 2010
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zeynep Cetin, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701831
- Sponsor's protocol ID
- LANTU_L_03502
- Acronym
- LANTIT
- Status last verified
- Nov 2010
- First submitted
- 18 Jun 2008
- Last updated
- 4 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients
- ClinicalTrials.gov ID
- NCT00701831
- Acronym / sponsor ID
- LANTIT / LANTU_L_03502
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Jun 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.
Primary objective:
- To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients
Secondary objectives:
- To assess the forced titration on physician and patient satisfaction
- To evaluate the impact of training tools by means of patient profile
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin glargineInsulin glargine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- T2 insulin naïve patients
- Patients whom their physician is considering initiation of Lantus treatment
- Poor glycemic control 7,5 %10 %
- T2 treatment with OADs more than 3 months
- BMI<40 kg/m2
Key exclusion criteria (7 listed)
- Impaired renal function (Cr>2mg/dl or current renal dialysis)
- Acute or chronic metabolic acidosis
- Active liver disease or serum ALT or AST >2,5 than normal
- History of hypoglycemia unawareness
- Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
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 glargineThe dose is titrated according to patient needs | Drug | 1 |
Primary outcome
HbA1c, FBG
Time frame: after treatment end (6 months)
Final dose
Time frame: after treatment end (6 months)
Number of dose adjustment
Time frame: after treatment end (6 months)
Time to dose titration
Time frame: after treatment end (6 months)
4 secondary outcomes
Hypoglycemia
Time frame: after treatment end (6 months)
Noctural hypoglycemia
Time frame: after treatment end (6 months)
DTSQ
Time frame: after treatment end (6 months)
Physician Satisfaction Questionnaire
Time frame: after treatment end (6 months)
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 4 Nov 2010.
Related trials for Diabetes Mellitus, Type 2
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.
Zeynep Cetin 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 in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Turkey (Türkiye).
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 7 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 4 Nov 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 Turkey (Türkiye). 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?
HbA1c, FBG (time frame: after treatment end (6 months)). The study lists 4 primary outcomes in all. 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 4 Nov 2010.