Type 2 Diabetes MellitusPhase 3NCT01457911
Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
A Phase 3 study testing Glimepiride and Metformin hydrochloride combination (HOE490) and Glimepiride (HOE490) in people with Type 2 Diabetes Mellitus, run by Sanofi at 22 sites in China.
Trial summary
Primary Objective: To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glimepiride and Metformin hydrochloride combination (HOE490) and Glimepiride (HOE490)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 22 sitesChina
- Study dates
- Oct 2011to Feb 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese patients with type 2 diabetes mellitus, as defined by World Health Organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin
- Signed written informed consent
Who cannot join
- Type 1 diabetes mellitus
- HbA1c < 7% or > 10%
- Fasting plasma glucose > 250 mg/dL (> 13.9 mmol/L)
- Age <18 years or Age ≥ 80 years
- Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening
- Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening
- 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
22 sites in 1 country.
22 sites in 1 country
China22 sites
Investigational Site Number 156001
Beijing, 100044
Investigational Site Number 156016
Beijing, 100088
Investigational Site Number 156003
Beijing, 100730
Investigational Site Number 156018
Beijing, 100730
Investigational Site Number 156002
Beijing, 100853
Investigational Site Number 156019
Changchun, 130041
Investigational Site Number 156017
Chengdu, 610083
Investigational Site Number 156014
Guangzhou, 510080
Investigational Site Number 156022
Guangzhou, 510150
Investigational Site Number 156011
Hangzhou, 310003
Investigational Site Number 156012
Hefei, 230001
Investigational Site Number 156020
Jinan, 250012
Investigational Site Number 156023
Jinan, 250021
Investigational Site Number 156010
Shanghai, 200040
Investigational Site Number 156006
Shanghai, 200072
Investigational Site Number 156009
Shanghai, 200080
Investigational Site Number 156021
Shenyang, 110022
Investigational Site Number 156005
Shijiazhuang, 050051
Investigational Site Number 156004
Taiyuan, 030001
Investigational Site Number 156024
Tianjin, 300052
Investigational Site Number 156008
Wuhan, 430022
Investigational Site Number 156015
Xiamen, 361003
About this study
Official title: A Multicenter, Randomized, Open-label, 2-arm Parallel Group, 20-week Study Comparing the Efficacy and Safety of Fixed-dose Combination of 1 mg Glimepiride and 250 mg Metformin (AMARYL M 1/250 mg) Versus Glimepiride (AMARYL®) in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin.
Primary Objective:
- To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.
Read more
Secondary Objectives:
- To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
- To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
- To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).
Read the detailed description
The study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. Total study duration is up to 23 weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glimepiride and Metformin hydrochloride combination (HOE490), Glimepiride (HOE490)
- 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 and Metformin hydrochloride combination (HOE490)Drug
Pharmaceutical form:tablet Route of administration: oral
Glimepiride (HOE490)Drug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| AMARYL M (Glimepiride and Metformin hydrochloride combination) | Experimental | AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal Receives: Drug: Glimepiride and Metformin hydrochloride combination (HOE490) |
| AMARYL (Glimepiride) | Active comparator | AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal Receives: Drug: Glimepiride (HOE490) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in HbA1c
Measured: 20 weeks, from baseline to week 20
Secondary outcomes (7)
Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively
Measured: 20 weeks, at week 20
Absolute change in Fasting Plasma Glucose
Measured: 20 weeks, from baseline to week 20
Number of patients reporting adverse events
Measured: 20 weeks, from baseline to week 20
Number of patients reporting serious adverse events
Measured: 20 weeks, from baseline to week 20
Hypoglycemia
Measured: 20 weeks, from baseline to week 20
Vital signs
Measured: 20 weeks, from baseline to week 20
Hematology, Serum chemistry and lipids
Measured: 20 weeks, from baseline to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 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
- NCT01457911
- Sponsor's protocol ID
- EFC11761
- Other IDs
- U1111-1121-6792
- Status last verified
- May 2014
- First submitted
- 20 Oct 2011
- 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 Multicenter, Randomized, Open-label, 2-arm Parallel Group, 20-week Study Comparing the Efficacy and Safety of Fixed-dose Combination of 1 mg Glimepiride and 250 mg Metformin (AMARYL M 1/250 mg) Versus Glimepiride (AMARYL®) in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin.
- ClinicalTrials.gov ID
- NCT01457911
- Acronym / sponsor ID
- EFC11761
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 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 evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.
Secondary Objectives:
- To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
- To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
- To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).
Detailed description
The study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. Total study duration is up to 23 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMARYL M (Glimepiride and Metformin hydrochloride combination) | Experimental | Drug: Glimepiride and Metformin hydrochloride combination (HOE490)AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal |
| AMARYL (Glimepiride) | Active comparator | Drug: Glimepiride (HOE490)AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chinese patients with type 2 diabetes mellitus, as defined by World Health Organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin
- Signed written informed consent
Key exclusion criteria (7 listed)
- Type 1 diabetes mellitus
- HbA1c < 7% or > 10%
- Fasting plasma glucose > 250 mg/dL (> 13.9 mmol/L)
- Age <18 years or Age ≥ 80 years
- Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening
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 and Metformin hydrochloride combination (HOE490)Pharmaceutical form:tablet Route of administration: oral | Drug | AMARYL M (Glimepiride and Metformin hydrochloride combination) |
| Glimepiride (HOE490)Pharmaceutical form:tablet Route of administration: oral | Drug | AMARYL (Glimepiride) |
Primary outcome
Absolute change in HbA1c
Time frame: 20 weeks, from baseline to week 20
7 secondary outcomes
Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively
Time frame: 20 weeks, at week 20
Absolute change in Fasting Plasma Glucose
Time frame: 20 weeks, from baseline to week 20
Number of patients reporting adverse events
Time frame: 20 weeks, from baseline to week 20
Number of patients reporting serious adverse events
Time frame: 20 weeks, from baseline to week 20
Hypoglycemia
Time frame: 20 weeks, from baseline to week 20
Vital signs
Time frame: 20 weeks, from baseline to week 20
Hematology, Serum chemistry and lipids
Time frame: 20 weeks, from baseline to week 20
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.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glimepiride and Metformin hydrochloride combination (HOE490) and Glimepiride (HOE490) in people with Type 2 Diabetes Mellitus, run by Sanofi at 22 sites in China.
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 22 sites in China. 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?
Absolute change in HbA1c (time frame: 20 weeks, from baseline to week 20). 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.