Diabetes Mellitus, Type 2Phase 4NEWLANNCT02606357
Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan
A Phase 4 study testing INSULIN GLARGINE in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Jordan.
Trial summary
Primary Objective: -To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine). Secondary Objectives: To evaluate the percentage of patients achieving target of HbA1c ˂7%. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteJordan
- Study dates
- 22 Nov 2015to 27 Nov 2017
- 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
- Patient ≥ 18 years old.
- Male or Female.
- Type 2 diabetes patients.
- Uncontrolled with previous therapy (HbA1c >7%), evident in HbA1c test within the last 1 month before study entry.
- Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD combination), at maximum tolerated dose in the last 3 months.
- Signed informed consent.
- Signed informed consent.
Who cannot join
- Patient not willing or not able to perform self-monitoring blood glucose.
- Patient not willing or not able to self-titrate insulin glargine under physician's guidance.
- Patient not suitable for participation according to what is specified in the approved Summary of Product's Characteristics or according to medical or clinical conditions, as judged by the Investigator.
- History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than three times the upper limit of normal, evident in testing done in the last 3 months.
- History of impaired renal function defined as serum creatinine >135 μmol/L (>1.525 mg/dL)in men and >110 μmol/L (>1.243 mg/dL) in women, evident in testing done in the last 3 months.
- Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method at physician's discretion).
- Treatment with systemic corticosteroid within 3 months prior to study entry.
- 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: Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan
Primary Objective:
-To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).
Secondary Objectives:
- To evaluate the percentage of patients achieving target of HbA1c ˂7%.
- To evaluate the change in fasting plasma glucose (FPG).
- To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.
- Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.
Read the detailed description
The total duration of study period per patient is up to 6 months.
- 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
Also called HOE901
Pharmaceutical form:Solution
Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| HOE901 | Experimental | HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels Receives: Drug: INSULIN GLARGINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Measured: Baseline, 6 months
Secondary outcomes (8)
- Percentage of patients achieving target of HbA1c <7%
Measured: 6 months
- Change from baseline in fasting plasma glucose values
Measured: Baseline, 3 months, and 6 months
- Percentage of patients with hypoglycemic events
Measured: Baseline, 6 months
- Change from baseline in body weight
Measured: Baseline, 3 months and 6 months
- Number of patients with adverse events
Measured: Baseline, 6 months
- Change in dose of insulin glargine
Measured: 3 months and 6 months
- Change in the titration doses used (if any)
Measured: 6 months
- Time to reach control
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start22 Nov 2015
- Primary completion27 Nov 2017
- Study completion27 Nov 2017
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
- 242 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
- NCT02606357
- Sponsor's protocol ID
- LANTUL07225
- Other IDs
- U1111-1172-1002
- Acronym
- NEWLAN
- Status last verified
- Oct 2018
- First submitted
- 13 Nov 2015
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan
- ClinicalTrials.gov ID
- NCT02606357
- Acronym / sponsor ID
- NEWLAN / LANTUL07225
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2015 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 17 Nov 2015 (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 assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).
Secondary Objectives:
- To evaluate the percentage of patients achieving target of HbA1c ˂7%.
- To evaluate the change in fasting plasma glucose (FPG).
- To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.
- Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.
Detailed description
The total duration of study period per patient is up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOE901 | Experimental | Drug: INSULIN GLARGINEHOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient ≥ 18 years old.
- Male or Female.
- Type 2 diabetes patients.
- Uncontrolled with previous therapy (HbA1c >7%), evident in HbA1c test within the last 1 month before study entry.
- Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD combination), at maximum tolerated dose in the last 3 months.
Key exclusion criteria (8 listed)
- Patient not willing or not able to perform self-monitoring blood glucose.
- Patient not willing or not able to self-titrate insulin glargine under physician's guidance.
- Patient not suitable for participation according to what is specified in the approved Summary of Product's Characteristics or according to medical or clinical conditions, as judged by the Investigator.
- History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than three times the upper limit of normal, evident in testing done in the last 3 months.
- History of impaired renal function defined as serum creatinine >135 μmol/L (>1.525 mg/dL)in men and >110 μmol/L (>1.243 mg/dL) in women, evident in testing done in the last 3 months.
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: HOE901Pharmaceutical form:Solution Route of administration: Subcutaneous | Drug | HOE901 |
Primary outcome
Change from baseline in HbA1c
Time frame: Baseline, 6 months
8 secondary outcomes
- Percentage of patients achieving target of HbA1c <7%
Time frame: 6 months
- Change from baseline in fasting plasma glucose values
Time frame: Baseline, 3 months, and 6 months
- Percentage of patients with hypoglycemic events
Time frame: Baseline, 6 months
- Change from baseline in body weight
Time frame: Baseline, 3 months and 6 months
- Number of patients with adverse events
Time frame: Baseline, 6 months
- Change in dose of insulin glargine
Time frame: 3 months and 6 months
- Change in the titration doses used (if any)
Time frame: 6 months
- Time to reach control
Time frame: 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 12 Oct 2018.
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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
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 Jordan.
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 7 inclusion and 8 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 12 Oct 2018. 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 Jordan. 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 from baseline in HbA1c (time frame: Baseline, 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 12 Oct 2018.