Type 2 Diabetes MellitusPhase 3LEGENDNCT01699932
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
A Phase 3 study testing Glimepiride+metformin (Amaryl M®) - HOE4900 in people with Type 2 Diabetes Mellitus, run by Sanofi at 13 sites in 3 countries.
Trial summary
Primary Objective: -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glimepiride+metformin (Amaryl M®) - HOE4900
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Sep 2012to Apr 2014
- Phase
- Phase 3
- 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
- Patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (SU) alone or metformin alone or a free combination of SU and metformin prior to the study entry.
- Signed informed consent, obtained prior any study procedure
Who cannot join
- Age < legal age of adulthood
- HbA1c < 7% or ≥ 11%
- BMI > 35 kg/m2
- Treatment with a stable dose of maximally tolerated SU alone or metformin alone or the free combination of SU and metformin for less than 12 weeks prior to the screening visit.
- Patients who received any anti-diabetic drug other than SU or metformin within 12 weeks prior to the screening visit.
- Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake…)
- 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
13 sites in 3 countries.
13 sites in 3 countries
Ukraine8 sites
Investigational Site Number 804003
Chernivtsi, 58022
Investigational Site Number 804008
Donetsk, 83003
Investigational Site Number 804004
Donetsk, 83059
Investigational Site Number 804001
Donetsk, 83099
Investigational Site Number 804010
Odesa
Investigational Site Number 804006
Poltava, 36011
Investigational Site Number 804007
Vinnytsia, 21010
Investigational Site Number 804002
Vinnytsia, 21029
Russia3 sites
Investigational Site Number 643-03
Saint Petersburg
Investigational Site Number 643002
Saint Petersburg
Investigational Site Number 643001
Samara
Lebanon2 sites
Investigational Site Number 422-002
Beirut
Investigational Site Number 422-001
Hazmiyeh
About this study
Official title: A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes
Primary Objective:
-To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.
Secondary Objective:
To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:
- Percentage of patients reaching HbA1c <7%
- Percentage of patients reaching HbA1c <6.5%.
- Fasting Plasma Glucose (FPG)
- Safety and tolerability
Read the detailed description
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glimepiride+metformin (Amaryl M®) - HOE4900
- 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.
Glimepiride+metformin (Amaryl M®) - HOE4900Drug
Pharmaceutical form:tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 24-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia. Receives: Drug: Glimepiride+metformin (Amaryl M®) - HOE4900 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: from baseline to week 24
Secondary outcomes (5)
Percentage of patients with HbA1c < 7%
Measured: at week 24
Percentage of patients with HbA1c < 6.5%
Measured: at week 24
Change in Fasting Plasma Glucose (FPG)
Measured: from baseline to week 24
Number of patients with adverse events
Measured: over the 24-week treatment period
Hypoglycemia
Measured: over the 24-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 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
- NCT01699932
- Sponsor's protocol ID
- GLMET_R_05823
- Other IDs
- U1111-1120-0058
- Acronym
- LEGEND
- Status last verified
- May 2014
- First submitted
- 26 Sep 2012
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01699932
- Acronym / sponsor ID
- LEGEND / GLMET_R_05823
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Oct 2012 (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 demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.
Secondary Objective:
To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:
- Percentage of patients reaching HbA1c <7%
- Percentage of patients reaching HbA1c <6.5%.
- Fasting Plasma Glucose (FPG)
- Safety and tolerability
Detailed description
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Glimepiride+metformin (Amaryl M®) - HOE490024-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and > 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (SU) alone or metformin alone or a free combination of SU and metformin prior to the study entry.
- Signed informed consent, obtained prior any study procedure
Key exclusion criteria (7 listed)
- Age < legal age of adulthood
- HbA1c < 7% or ≥ 11%
- BMI > 35 kg/m2
- Treatment with a stable dose of maximally tolerated SU alone or metformin alone or the free combination of SU and metformin for less than 12 weeks prior to the screening visit.
- Patients who received any anti-diabetic drug other than SU or metformin within 12 weeks prior to the screening visit.
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 |
|---|---|---|
| Glimepiride+metformin (Amaryl M®) - HOE4900Pharmaceutical form:tablet Route of administration: oral | Drug | Arm 1 |
Primary outcome
Change in HbA1c
Time frame: from baseline to week 24
5 secondary outcomes
Percentage of patients with HbA1c < 7%
Time frame: at week 24
Percentage of patients with HbA1c < 6.5%
Time frame: at week 24
Change in Fasting Plasma Glucose (FPG)
Time frame: from baseline to week 24
Number of patients with adverse events
Time frame: over the 24-week treatment period
Hypoglycemia
Time frame: over the 24-week treatment period
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 8 May 2014.
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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
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glimepiride+metformin (Amaryl M®) - HOE4900 in people with Type 2 Diabetes Mellitus, run by Sanofi at 13 sites in 3 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 2 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Ukraine, Russia, Lebanon. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (time frame: from baseline to week 24). 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 8 May 2014.