Diabetes Mellitus, Type 2Phase 4NCT01013571
Self Titration With Apidra to Reach Target Study (START)
A Phase 4 study testing insulin glargine and Apidra (insulin glulisine) in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Canada.
Trial summary
Primary Objective: The primary objective of this study is to demonstrate non-inferiority of a patient-managed titration algorithm (including blood glucose monitoring) for the addition of a single dose of insulin glulisine at breakfast in Canadian patients with inadequately controlled T2DM after optimization of basal… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- insulin glargine and Apidra (insulin glulisine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Run-in phase:
- T2DM
- Treated for at least 3 months with a basal insulin (insulin glargine, NPH, detemir) +/- oral antidiabetic drugs (OADs) with an HbA1c >7.0% or insulin naive (2-3 OADs) with an HbA1c >=7.8% (historic HbA1c result up to 3 months of screening is acceptable)
- Randomized treatment phase:
- Completed run-in phase
- HbA1c >7.0% and >= 1 episode of confirmed nocturnal hypoglycemia (BG <4.0 mmol/L) or >= 2 measurements of FG <=6.0 mmol/L within the previous week Patients who completed the run-in phase with HbA1c >7.0% and did not meet the randomization criteria will continue titrating insulin glargine and be followed until the end of study.
Who cannot join
- No food intake before lunch (noon)
- Unstable diet intake or significant changes to current diet regimen
- Nightshift worker
- Type 1 Diabetes Mellitus
- Subjects unwilling to inject insulin or perform self-monitoring blood glucose
- Pregnant, alcohol or drug abuse
Show all 10Show fewer
- Active cancer or any other disease or condition which in the opinion of the investigator would make the subject unsuitable for participation in the study
- Any clinical significant laboratory findings that in the judgment of the investigator would preclude safe completion of the study
- Known allergies to study drugs
- 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 Canadian, Phase IV, Multicenter, Comparative, Open-label Study Evaluating 2 Approaches of Blood Glucose Monitoring and Insulin Titration (Patient-managed vs Health Care Professional) in T2DM Patients While Receiving the Addition of 1 Injection of Insulin Glulisine at Breakfast Following Optimization of Insulin Glargine
Primary Objective:
The primary objective of this study is to demonstrate non-inferiority of a patient-managed titration algorithm (including blood glucose monitoring) for the addition of a single dose of insulin glulisine at breakfast in Canadian patients with inadequately controlled T2DM after optimization of basal insulin, compared with an HCP-managed titration algorithm. The primary endpoint for assessment of this objective is the percent of patients reaching a target HbA1c <=7.0% without severe hypoglycemia at the end of the study.
Read more
Secondary Objective:
Secondary objectives of the study are to compare the effect of the two different insulin glulisine titration algorithms (patient-managed versus HCP-managed) on the following:
- change in HbA1c, FG, and 7-point glucose profile at Week 24 and Week 36
- satisfaction with treatment (DTSQc for patient and questionnaire for HCP) at Week 36
- change in weight at Week 24 and Week 36
- incidence of hypoglycemia
- insulin doses
- resource utilization (rural/urban, blood glucose meter test strips, lancets, HCP visits, telephone calls, and hospitalizations)
- adherence with the patient-managed monitoring algorithm
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- insulin glargine, Apidra (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
pre-filled disposable pen, in package of 5.
Apidra (insulin glulisine)Drug
pre-filled disposable pen, in package of 5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; health care professional-managed Receives: Drug: insulin glargine; Drug: Apidra (insulin glulisine) |
| 2 | Experimental | 12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; patient-managed Receives: Drug: insulin glargine; Drug: Apidra (insulin glulisine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia
Measured: at week 36 (end of study)
Secondary outcomes (5)
Change in HbA1c, FG, and 7-point glucose profile
Measured: from Week 12 (randomization) to Week 24 and Week 36
Change in weight
Measured: from Week 12 to Week 24 and to Week 36
Incidence of hypoglycemia
Measured: Week 12 , Week 24 and Week 36
Treatment satisfaction (DTSQ for patient )
Measured: from Week 12 to Week 36
Adherence with the patient-managed monitoring algorithm
Measured: Week 12 , Week 24 and Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2012
- Study completionJan 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 493 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
- NCT01013571
- Sponsor's protocol ID
- LANTU_L_04695
- Status last verified
- Mar 2012
- First submitted
- 12 Nov 2009
- Last updated
- 21 Mar 2012
- Results posted
- No
Publications
Harris SB, Yale JF, Berard L, Stewart J, Abbaszadeh B, Webster-Bogaert S, Gerstein HC. Does a patient-managed insulin intensification strategy with insulin glargine and insulin glulisine provide similar glycemic control as a physician-managed strategy? Results of the START (Self-Titration With Apidra to Reach Target) Study: a randomized noninferiority trial. Diabetes Care. 2014;37(3):604-10. doi: 10.2337/dc13-1636. Epub 2013 Oct 29.
PubMed 24170757
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Canadian, Phase IV, Multicenter, Comparative, Open-label Study Evaluating 2 Approaches of Blood Glucose Monitoring and Insulin Titration (Patient-managed vs Health Care Professional) in T2DM Patients While Receiving the Addition of 1 Injection of Insulin Glulisine at Breakfast Following Optimization of Insulin Glargine
- ClinicalTrials.gov ID
- NCT01013571
- Acronym / sponsor ID
- LANTU_L_04695
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Nov 2009 (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 objective of this study is to demonstrate non-inferiority of a patient-managed titration algorithm (including blood glucose monitoring) for the addition of a single dose of insulin glulisine at breakfast in Canadian patients with inadequately controlled T2DM after optimization of basal insulin, compared with an HCP-managed titration algorithm. The primary endpoint for assessment of this objective is the percent of patients reaching a target HbA1c <=7.0% without severe hypoglycemia at the end of the study.
Secondary Objective:
Secondary objectives of the study are to compare the effect of the two different insulin glulisine titration algorithms (patient-managed versus HCP-managed) on the following:
- change in HbA1c, FG, and 7-point glucose profile at Week 24 and Week 36
- satisfaction with treatment (DTSQc for patient and questionnaire for HCP) at Week 36
- change in weight at Week 24 and Week 36
- incidence of hypoglycemia
- insulin doses
- resource utilization (rural/urban, blood glucose meter test strips, lancets, HCP visits, telephone calls, and hospitalizations)
- adherence with the patient-managed monitoring algorithm
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: Apidra (insulin glulisine)12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; health care professional-managed |
| 2 | Experimental | Drug: insulin glargine, Drug: Apidra (insulin glulisine)12-week run-in phase with Glargine +/- OADs followed by 24-week treatment phase with glulisine (AM) + glargine ; patient-managed |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- T2DM
- Treated for at least 3 months with a basal insulin (insulin glargine, NPH, detemir) +/- oral antidiabetic drugs (OADs) with an HbA1c >7.0% or insulin naive (2-3 OADs) with an HbA1c >=7.8% (historic HbA1c result up to 3 months of screening is acceptable)
- Completed run-in phase
- HbA1c >7.0% and >= 1 episode of confirmed nocturnal hypoglycemia (BG <4.0 mmol/L) or >= 2 measurements of FG <=6.0 mmol/L within the previous week Patients who completed the run-in phase with HbA1c >7.0% and did not meet the randomization criteria will continue titrating insulin glargine and be followed until the end of study.
Key exclusion criteria (10 listed)
- No food intake before lunch (noon)
- Unstable diet intake or significant changes to current diet regimen
- Nightshift worker
- Type 1 Diabetes Mellitus
- Subjects unwilling to inject insulin or perform self-monitoring blood glucose
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 glarginepre-filled disposable pen, in package of 5. | Drug | 1, 2 |
| Apidra (insulin glulisine)pre-filled disposable pen, in package of 5 | Drug | 1, 2 |
Primary outcome
Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia
Time frame: at week 36 (end of study)
5 secondary outcomes
Change in HbA1c, FG, and 7-point glucose profile
Time frame: from Week 12 (randomization) to Week 24 and Week 36
Change in weight
Time frame: from Week 12 to Week 24 and to Week 36
Incidence of hypoglycemia
Time frame: Week 12 , Week 24 and Week 36
Treatment satisfaction (DTSQ for patient )
Time frame: from Week 12 to Week 36
Adherence with the patient-managed monitoring algorithm
Time frame: Week 12 , Week 24 and Week 36
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 21 Mar 2012.
- Derived from this study: PubMed 24170757Harris SB, Yale JF, Berard L, Stewart J, Abbaszadeh B, Webster-Bogaert S, Gerstein HC. Does a patient-managed insulin intensification strategy with insulin glargine and insulin glulisine provide similar glycemic control as a physician-managed strategy? Results of the START (Self-Titration With Apidra to Reach Target) Study: a randomized noninferiority trial. Diabetes Care. 2014;37(3):604-10. doi: 10.2337/dc13-1636. Epub 2013 Oct 29.
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
RecruitingObservational study
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
Type 1 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
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 and Apidra (insulin glulisine) in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Canada.
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 6 inclusion and 10 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 21 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 1 site in Canada. 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?
Percentage of subjects reaching target HbA1c <=7.0% without severe hypoglycemia (time frame: at week 36 (end of study)). 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 NCT01013571, 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 21 Mar 2012; AzTrials last refreshed its copy on 27 Oct 2026.