Diabetes Mellitus, Type 2Phase 4CHANGINGNCT01203111
Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
A Phase 4 study testing INSULIN GLARGINE and INSULIN GLULISINE in people with Diabetes Mellitus, Type 2, run by Sanofi at 10 sites in 10 countries.
Trial summary
Primary Objective: To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10). Secondary Objectives: 1. Percentage of patients with HbA1c < 7% at week 24. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 207 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Dec 2010to Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- in the run-in period:
- Uncontrolled Type 2 diabetes mellitus defined as HbA1c level between 7,5% and 10% assessed over the past 6 months
- Male or female patients from 18-75 years old inclusive
- Body Mass Index (BMI) between 25 and 40 kg/m2
- Currently treated with a basal insulin (NPH, insulin zinc or insulin detemir), plus at least 1g metformin daily, and other Oral Glucose Lowering Drug (OGLD) if any for at least 3 months
- Signed Informed consent obtained prior to any study procedures
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- in the treatment period:
- HbA1c level between 7,5% and 10% assessed between week -2 and week 0
- Serum creatinine <= 135 µmol/L in men and <= 110 µmol/L in women
- Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) <= 3 times the upper limit of normal
- Negative pregnancy test for women of childbearing potential
Who cannot join
- Type 1 diabetes mellitus
- Active proliferative diabetic retinopathy, defined as the application of photocoagulation or surgery performed within 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed over the past 2 years)
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- History of impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal
- History of impaired renal function defined as serum creatinine >135 µmol/l in men and > 110 µmol/l in women
- History of drug or alcohol abuse
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- Type 2 Diabetes Mellitus (T2DM) patients treated exclusively with OGLDs
- T2DM patients treated with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
- Previous treatment with insulin glulisine
- Concomitant treatment with thiazolidinediones, exenatide or pramlintide
- Treatment with systemic corticosteroids within 3 months prior to study entry
- Treatment with any investigational product within 2 months prior to study entry
- History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
- Presence of mental condition that, in the opinion of the investigator, indicates that participation in the study is not in the best interest of the patient
- Presence of geographic or social conditions that would restrict or limit the patient participation for the duration of the study
- Pregnant or breast feeding women
- Women of childbearing potential not protected by effective contraceptive method of birth control
- 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 10 countries.
10 sites in 10 countries
About this study
Official title: Efficacy and Safety of Intensive Insulin Therapy With Insulin Glulisine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
Primary Objective:
To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10).
Read more
Secondary Objectives:
- Percentage of patients with HbA1c < 7% at week 24.
- Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24.
- Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24.
- Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24.
- Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24.
- Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.
Read the detailed description
The study is divided in 3 periods:
- a 2-week run-in period,
- a 12-week treatment period 1
- a 12-week treatment period 2 study treatment duration per patient: 24 weeks study duration per patient: 26 weeks
- 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
Also called Lantus SoloStar
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day in the evening at bedtime
INSULIN GLULISINEDrug
Also called Apidra SoloStar
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day, 0 to 15 minutes before the main meal
| Study group | Role | What they receive |
|---|---|---|
| Intensive insulin regimen | Experimental | Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥7% at week 12 (end of treatment period 1) Receives: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE |
| insulin regimen | Experimental | Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: no change, if HbA1c <7% at week 12 (end of treatment period 1) Receives: Drug: INSULIN GLARGINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c level for patients with addition of glulisine at week 12
Measured: between week 12 and week 24 (end of treatment period)
Secondary outcomes (8)
Percentage of patients with HbA1c level < 7%
Measured: at week 24 (end of treatment period)
Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event
Measured: at week 24 (end of treatment period)
Fasting Plasma Glucose
Measured: at week 0, week 12 and week 24
7-point Self Monitoring of Blood Glucose
Measured: at week 0, week 12 and week 24
Daily dose of insulin glargine
Measured: at week 24 (end of treatment period)
Daily dose of insulin glulisine
Measured: at week 24 (end of treatment period)
Systolic / diastolic blood pressure, heart rate, weight change
Measured: from week 0 (baseline) to week 24 (end of treatment period)
Hypoglycemia (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe)
Measured: from week 0 (from baseline) to week 24 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2012
- Study completionJul 2012
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 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
- NCT01203111
- Sponsor's protocol ID
- LANTU_R_05048
- Other IDs
- U1111-1116-3517
- Acronym
- CHANGING
- Status last verified
- Aug 2012
- First submitted
- 14 Sep 2010
- Last updated
- 30 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intensive Insulin Therapy With Insulin Glulisine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
- ClinicalTrials.gov ID
- NCT01203111
- Acronym / sponsor ID
- CHANGING / LANTU_R_05048
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Sep 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:
To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10).
Secondary Objectives:
- Percentage of patients with HbA1c < 7% at week 24.
- Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24.
- Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24.
- Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24.
- Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24.
- Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.
Detailed description
The study is divided in 3 periods:
- a 2-week run-in period,
- a 12-week treatment period 1
- a 12-week treatment period 2 study treatment duration per patient: 24 weeks study duration per patient: 26 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive insulin regimen | Experimental | Drug: INSULIN GLARGINE, Drug: INSULIN GLULISINETreatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥7% at week 12 (end of treatment period 1) |
| insulin regimen | Experimental | Drug: INSULIN GLARGINETreatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: no change, if HbA1c <7% at week 12 (end of treatment period 1) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- in the run-in period:
- in the treatment period:
Key exclusion criteria (18 listed)
- Type 1 diabetes mellitus
- Active proliferative diabetic retinopathy, defined as the application of photocoagulation or surgery performed within 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed over the past 2 years)
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- History of impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal
- History of impaired renal function defined as serum creatinine >135 µmol/l in men and > 110 µmol/l in 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 GLARGINEAlso: Lantus SoloStarPharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day in the evening at bedtime | Drug | Intensive insulin regimen, insulin regimen |
| INSULIN GLULISINEAlso: Apidra SoloStarPharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day, 0 to 15 minutes before the main meal | Drug | Intensive insulin regimen |
Primary outcome
Change in HbA1c level for patients with addition of glulisine at week 12
Time frame: between week 12 and week 24 (end of treatment period)
8 secondary outcomes
Percentage of patients with HbA1c level < 7%
Time frame: at week 24 (end of treatment period)
Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event
Time frame: at week 24 (end of treatment period)
Fasting Plasma Glucose
Time frame: at week 0, week 12 and week 24
7-point Self Monitoring of Blood Glucose
Time frame: at week 0, week 12 and week 24
Daily dose of insulin glargine
Time frame: at week 24 (end of treatment period)
Daily dose of insulin glulisine
Time frame: at week 24 (end of treatment period)
Systolic / diastolic blood pressure, heart rate, weight change
Time frame: from week 0 (baseline) to week 24 (end of treatment period)
Hypoglycemia (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe)
Time frame: from week 0 (from baseline) to week 24 (end of treatment)
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 Aug 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 10 countries: 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 10 countries.
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 11 inclusion and 18 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 Aug 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 Algeria, Brazil, Israel, Lebanon, Mexico and 5 more countries. 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?
Change in HbA1c level for patients with addition of glulisine at week 12 (time frame: between week 12 and week 24 (end of treatment period)). 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 Aug 2012.