Diabetes Mellitus, Type 2Phase 4AMIT KZNCT01144728
Initiation and Titration of Amaryl
A Phase 4 study testing GLIMEPIRIDE + METFORMIN in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Kazakhstan.
Trial summary
Primary Objective: To describe the conditions of initiation and titration of Amaryl M, according to previous treatment: initial dose titration scheme efficacy after 4 months assessed by HbA1C tolerability (number and severity of hypoglycaemia) Secondary Objective: Fasting Plasma Glucose Weight evolution Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GLIMEPIRIDE + METFORMIN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteKazakhstan
- Study dates
- May 2010to Dec 2010
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 2 diabetes who have been treated with a stable dose (any dose) of :
- sulfonylurea monotherapy or
- metformin monotherapy or
- free combination of glimepiride and metformin with a stable dose (any dose)
- Body Mass Index (BMI) between 20 and 40 kg/m2
- HbA1c superior or egal to 7.5%
- FPG superior or egal 7 mmol/l
Who cannot join
- Secondary or insulin-dependant diabetes
- Any severe chronic disease (hepatic, renal impairments)
- History of major cardiovascular event in the last 6 months
- Acute conditions with the potential to alter renal function such as: dehydratation, severe infection, shock, IV administration of iodinated contrast agents
- Allergy to sulfonylurea, metformin
- Drug or alcohol abuse
- Pregnancy, lactation
- 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: AMIT Study - Amaryl M Initiation and Titration Study
Primary Objective:
- To describe the conditions of initiation and titration of Amaryl M, according to previous treatment:
- initial dose
- titration scheme
- efficacy after 4 months assessed by HbA1C
- tolerability (number and severity of hypoglycaemia)
Secondary Objective:
- Fasting Plasma Glucose
- Weight evolution
- 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.
GLIMEPIRIDE + METFORMINDrug
Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500
| Study group | Role | What they receive |
|---|---|---|
| Single arm Glimepiride+metformin | Experimental | Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks. Receives: Drug: GLIMEPIRIDE + METFORMIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycolysated Haemoglobin (HbA1c)
Measured: From baseline to Month 4
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
Measured: Month 4
Evolution of Fasting Plasma Glucose (FPG)
Measured: From baseline to Months 4
Secondary outcomes (5)
Post Prandial Plasma Glucose (PPPG)
Measured: Month 4
Number of patients for each start dose
Measured: At baseline
Number of patients with different final doses
Measured: Month 4
Rate of Symptomatic Hypoglycemia
Measured: During treatment period (4 months)
Change in Weight
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionDec 2010
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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144728
- Sponsor's protocol ID
- GLMET_L_04718
- Other IDs
- U1111-1116-9956
- Acronym
- AMIT KZ
- Status last verified
- Jan 2011
- First submitted
- 14 Jun 2010
- Last updated
- 31 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMIT Study - Amaryl M Initiation and Titration Study
- ClinicalTrials.gov ID
- NCT01144728
- Acronym / sponsor ID
- AMIT KZ / GLMET_L_04718
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Jun 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 describe the conditions of initiation and titration of Amaryl M, according to previous treatment:
- initial dose
- titration scheme
- efficacy after 4 months assessed by HbA1C
- tolerability (number and severity of hypoglycaemia)
Secondary Objective:
- Fasting Plasma Glucose
- Weight evolution
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm Glimepiride+metformin | Experimental | Drug: GLIMEPIRIDE + METFORMINStart and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with Type 2 diabetes who have been treated with a stable dose (any dose) of :
- sulfonylurea monotherapy or
- metformin monotherapy or
- free combination of glimepiride and metformin with a stable dose (any dose)
- Body Mass Index (BMI) between 20 and 40 kg/m2
Key exclusion criteria (8 listed)
- Secondary or insulin-dependant diabetes
- Any severe chronic disease (hepatic, renal impairments)
- History of major cardiovascular event in the last 6 months
- Acute conditions with the potential to alter renal function such as: dehydratation, severe infection, shock, IV administration of iodinated contrast agents
- Allergy to sulfonylurea, metformin
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 + METFORMINPharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500 | Drug | Single arm Glimepiride+metformin |
Primary outcome
Glycolysated Haemoglobin (HbA1c)
Time frame: From baseline to Month 4
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
Time frame: Month 4
Evolution of Fasting Plasma Glucose (FPG)
Time frame: From baseline to Months 4
5 secondary outcomes
Post Prandial Plasma Glucose (PPPG)
Time frame: Month 4
Number of patients for each start dose
Time frame: At baseline
Number of patients with different final doses
Time frame: Month 4
Rate of Symptomatic Hypoglycemia
Time frame: During treatment period (4 months)
Change in Weight
Time frame: Month 4
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 31 Jan 2011.
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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 GLIMEPIRIDE + METFORMIN in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Kazakhstan.
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 31 Jan 2011. 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 Kazakhstan. 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?
Glycolysated Haemoglobin (HbA1c) (time frame: From baseline to Month 4). The study lists 3 primary outcomes in all. 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 31 Jan 2011.