Diabetes Mellitus, Type 2Phase 3RECOMMENDNCT01459809
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
A Phase 3 study testing GLIMEPIRIDE and METFORMIN in people with Diabetes Mellitus, Type 2, run by Sanofi at 55 sites in 14 countries.
Trial summary
Primary Objective: To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GLIMEPIRIDE and METFORMIN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 55 sitesin 14 countries
- Study dates
- Feb 2012to Jan 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 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus, as defined by the World Health Organization (WHO), diagnosed within one year prior to the screening visit
- Signed informed consent, obtained prior to any study procedure
Who cannot join
- Age < 18 and => 78 years old
- HbA1c < 7.6% or > 9%
- BMI > 35 kg/m2
- Diabetes other than type 2 diabetes (e.g.: type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...)
- Subjects currently receiving or who have received any hypoglycemic agent within 3 months before screening visit
- 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
55 sites in 14 countries.
55 sites in 14 countries
India9 sites
Investigational Site Number 356001
Bangalore, 560043
Investigational Site Number 356002
Bangalore, 560052
Investigational Site Number 356006
Ernākulam
Investigational Site Number 356003
Indore, 452010
Investigational Site Number 356009
Lucknow, 226003
Investigational Site Number 356010
Mumbai
Investigational Site Number 356007
Nashik, 422002
Investigational Site Number 356008
Pune, 411007
Investigational Site Number 356005
Varanasi
Tunisia7 sites
Investigational Site Number 78803
La Marsa, 2070
Investigational Site Number 78804
La Marsa, 2070
Investigational Site Number 78805
Sfax
Investigational Site Number 78801
Tunis
Investigational Site Number 78802
Tunis
Investigational Site Number 78806
Tunis
Investigational Site Number 78807
Tunis
Turkey (Türkiye)6 sites
Investigational Site Number 792-004
Adana
Investigational Site Number 792-003
Antalya, 07070
Investigational Site Number 792-001
Istanbul, 34722
Investigational Site Number 792-006
Istanbul, 34890
Investigational Site Number 792-002
Kütahya
Investigational Site Number 792-005
Sivas, 58140
Guatemala4 sites
Investigational Site Number 32001
Guatemala City
Investigational Site Number 32002
Guatemala City
Investigational Site Number 32003
Guatemala City
Investigational Site Number 32004
Guatemala City
Lebanon4 sites
Investigational Site Number 42201
Beirut
Investigational Site Number 42202
Beirut
Investigational Site Number 42203
Chouf
Investigational Site Number 422004
Hazmiyeh
United Arab Emirates4 sites
Investigational Site Number 784-001
Dubai
Investigational Site Number 784-002
Dubai
Investigational Site Number 784-003
Dubai
Investigational Site Number 784-004
Sharjah city, 46458
Algeria3 sites
Investigational Site Number 01206
Algeries
Investigational Site Number 01203
Oran, 31000
Investigational Site Number 01205
Sétif, 19000
Egypt3 sites
Investigational Site Number 81801
Cairo
Investigational Site Number 81802
Cairo
Investigational Site Number 81803
Cairo
Iran3 sites
Investigational Site Number 364001
Tehran, 1411413137
Investigational Site Number 364002
Tehran, 1666694516
Investigational Site Number 36403
Tehran
Russia3 sites
Investigational Site Number 643003
Moscow, 119002
Investigational Site Number 643001
Saint Petersburg
Investigational Site Number 643002
Saratov, 410012
Ukraine3 sites
Investigational Site Number 804001
Kyiv, 02175
Investigational Site Number 804002
Kyiv, 04114
Investigational Site Number 804003
Zaporizhzhya
Colombia2 sites
Investigational Site Number 17003
El Espinal
Investigational Site Number 170001
Manizales, 170
Mexico2 sites
Investigational Site Number 484002
Guadalajara, 44340
Investigational Site Number 484003
Guadalajara, 44670
South Africa2 sites
Investigational Site Number 710-002
Durban, 4091
Investigational Site Number 710-001
Durban, 4092
About this study
Official title: A Multinational, Open Label, Randomized, Active-controlled, 3-arm Parallel Group, 24-week Study Comparing the Combination of Glimepiride and Metformin Versus Glimepiride and Metformin Alone in Patients With Type 2 Diabetes
Primary Objective:
- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.
Secondary Objectives:
- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone 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 where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GLIMEPIRIDE, METFORMIN
- 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.
GLIMEPIRIDEDrug
Also called HOE490
Pharmaceutical form: oral
Route of administration: oral
METFORMINDrug
Pharmaceutical form: oral
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: glimepiride alone | Experimental | 24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if Fasting Plasma Glucose (FPG) at baseline < 180 mg/dL (10 mmol/L) taken once in the morning before breakfast. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg, 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 |
| ARM 2: metformin alone | Experimental | 24-week treatment period: After randomization, starting dose will be of 500 mg of metformin twice a day during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 2000 mg, and adjusted throughout the 24-week treatment period according to fasting 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: METFORMIN |
| ARM3: Glimepiride/metformin free combination | Experimental | 24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if FPG at baseline < 180 mg/dL (10 mmol/L) taken once in the morning and 500 mg of metformin twice a day taken during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg of glimepiride and 2000 mg of metformin, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain values ≤. Receives: Drug: GLIMEPIRIDE; Drug: METFORMIN |
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 week 24
Number of patients reporting adverse events
Measured: overt the 24-weeks treatment period
Frequence and incidence of hypoglycemia
Measured: over the 24-weeks treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startFeb 2012
- Primary completionJan 2014
- Study completionJan 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 538 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
- NCT01459809
- Sponsor's protocol ID
- GLIME_R_05809
- Other IDs
- U1111-1119-9984
- Acronym
- RECOMMEND
- Status last verified
- Jan 2015
- First submitted
- 24 Oct 2011
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Open Label, Randomized, Active-controlled, 3-arm Parallel Group, 24-week Study Comparing the Combination of Glimepiride and Metformin Versus Glimepiride and Metformin Alone in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01459809
- Acronym / sponsor ID
- RECOMMEND / GLIME_R_05809
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Oct 2011 (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 superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.
Secondary Objectives:
- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone 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 where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM 1: glimepiride alone | Experimental | Drug: GLIMEPIRIDE24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if Fasting Plasma Glucose (FPG) at baseline < 180 mg/dL (10 mmol/L) taken once in the morning before breakfast. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg, 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. |
| ARM 2: metformin alone | Experimental | Drug: METFORMIN24-week treatment period: After randomization, starting dose will be of 500 mg of metformin twice a day during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 2000 mg, and adjusted throughout the 24-week treatment period according to fasting 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. |
| ARM3: Glimepiride/metformin free combination | Experimental | Drug: GLIMEPIRIDE, Drug: METFORMIN24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if FPG at baseline < 180 mg/dL (10 mmol/L) taken once in the morning and 500 mg of metformin twice a day taken during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg of glimepiride and 2000 mg of metformin, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain values ≤. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with type 2 diabetes mellitus, as defined by the World Health Organization (WHO), diagnosed within one year prior to the screening visit
- Signed informed consent, obtained prior to any study procedure
Key exclusion criteria (6 listed)
- Age < 18 and => 78 years old
- HbA1c < 7.6% or > 9%
- BMI > 35 kg/m2
- Diabetes other than type 2 diabetes (e.g.: type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...)
- Subjects currently receiving or who have received any hypoglycemic agent within 3 months before 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 |
|---|---|---|
| GLIMEPIRIDEAlso: HOE490Pharmaceutical form: oral Route of administration: oral | Drug | ARM 1: glimepiride alone, ARM3: Glimepiride/metformin free combination |
| METFORMINPharmaceutical form: oral Route of administration: oral | Drug | ARM 2: metformin alone, ARM3: Glimepiride/metformin free combination |
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 week 24
Number of patients reporting adverse events
Time frame: overt the 24-weeks treatment period
Frequence and incidence of hypoglycemia
Time frame: over the 24-weeks 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 21 Jan 2015.
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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
55 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GLIMEPIRIDE and METFORMIN in people with Diabetes Mellitus, Type 2, run by Sanofi at 55 sites in 14 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 6 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 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in India, Tunisia, Turkey (Türkiye), Guatemala, Lebanon and 9 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 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 21 Jan 2015.