Diabetes Mellitus, Non-Insulin-DependentPhase 3NCT00044447
Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients Unresponsive to Maximum Dose Metformin & Thiazolidinedione
A Phase 3 study testing Glimepiride in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Sanofi at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of Amaryl when added to Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM) patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- Glimepiride
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Sep 2002
- 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
- Patients must have given their signed informed consent.
- Males or females between 18 and 80 years old. Female patients must be surgically sterile, post-menopausal, or using an accepted method of birth control (i.e., oral contraceptives, intrauterine device, Norplant® system, Depo Provera®, or a spermicide and condom). Female patients of childbearing potential must have a negative serum pregnancy test and be advised not to become pregnant during the study.
- At least 1 year history of NIDDM and performing home blood glucose monitoring.
- Patients must have BMI of > 26 to < 42 kg/m2 at baseline (week 0).
- Patients must have HbA1C > 7.5% but < 9.5% at screen (week -4).
- Patients must have evidence of insulin secretory capacity (fasting C-peptide concentration > or equal to 0.27 nmol/l during the stabilization period).
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- Patients must have FPG > 130 mg/dl but < 235 mg/dl prior to (within 48-72 hours) randomization at Visit 1 Week 0.
- Patients must be receiving as their current diabetic therapy stable doses of metformin (at dose of 1.0-2.5gm/day), or metformin extended release at a maximum dose of 2 gm/day and a half maximum to a maximum dose of thiazolidinedione for at least 3 months.
- Patients must be able to understand and willing to adhere to and be compliant with the study protocol.
Who cannot join
- Patients who require insulin therapy or are currently on other sulfonylureas.
- Patients with a history of hypersensitivity to sulfonylureas.
- Patients with past history of severe hypoglycemia reaction on their current antidiabetic therapy requiring medical attention.
- Patients with a history of acute metabolic complications such as hyperosmolar coma or ketonuria.
- Patients with clinically significant abnormal baseline laboratory values (hematology, blood chemistry or urinalysis) which define a disease or condition, which in the opinion of the investigator may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate and complete the study. Should there be a laboratory value which, upon initial screening, is substantially outside the normal range, the test should be repeated.
- Patients who had an increase in their thiazolidinedione medication within 2 months of entering the study (Visit 0).
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- Patients who had an increase in the metformin medication within 1 month of entering the study (Visit 0).
- Patients whose body weight has changed more than 2% for patients < 250 pounds or 3% for patients >= 250 pounds, during the 4 week stabilization period when compared to the weight at the screening visit 0 (week - 4).
- Patients with acute infections.
- Patients who have received any drug (i.e. a chemotherapy agent) with a well-defined potential for toxicity to a major organ system during the three months prior to the study.
- Patients with clinically significant renal or hepatic disease (i.e. ALT > 2.5 x upper limit of normal) or gastrointestinal disorders that may interfere with absorption of the study drugs.
- Patients who are allergic to sulfonamides and excipients.
- Patients with any history of alcohol or drug abuse.
- Pregnant or lactating females will be excluded.
- Patients with a history of psychosis, emotional or intellectual problems that could impair the ability of the patient to participate in the study or to complete the study.
- Patients who have participated in any investigational study within 30 days prior to Visit 0.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230
About this study
Official title: A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Evaluate the Role of the Addition of Amaryl to NIDDM Patients Not Responding to Maximum Dose Metformin and Thiazolidinedione Therapy
The purpose of this study is to assess the efficacy and safety of Amaryl when added to Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM) patients.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- Glimepiride
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C from baseline to Week 26.
Secondary outcomes (1)
Incidence of hypoglycemia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2002 (estimated)
- Study startMay 2001
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies 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
- Double blind
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044447
- Sponsor's protocol ID
- HOE490/4033
- Status last verified
- Jun 2008
- First submitted
- 28 Aug 2002
- Last updated
- 19 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Evaluate the Role of the Addition of Amaryl to NIDDM Patients Not Responding to Maximum Dose Metformin and Thiazolidinedione Therapy
- ClinicalTrials.gov ID
- NCT00044447
- Acronym / sponsor ID
- HOE490/4033
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Study completion
- Sep 2002 (actual)
- First posted
- 30 Aug 2002 (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.
The purpose of this study is to assess the efficacy and safety of Amaryl when added to Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have given their signed informed consent.
- Males or females between 18 and 80 years old. Female patients must be surgically sterile, post-menopausal, or using an accepted method of birth control (i.e., oral contraceptives, intrauterine device, Norplant® system, Depo Provera®, or a spermicide and condom). Female patients of childbearing potential must have a negative serum pregnancy test and be advised not to become pregnant during the study.
- At least 1 year history of NIDDM and performing home blood glucose monitoring.
- Patients must have BMI of > 26 to < 42 kg/m2 at baseline (week 0).
- Patients must have HbA1C > 7.5% but < 9.5% at screen (week -4).
Key exclusion criteria (16 listed)
- Patients who require insulin therapy or are currently on other sulfonylureas.
- Patients with a history of hypersensitivity to sulfonylureas.
- Patients with past history of severe hypoglycemia reaction on their current antidiabetic therapy requiring medical attention.
- Patients with a history of acute metabolic complications such as hyperosmolar coma or ketonuria.
- Patients with clinically significant abnormal baseline laboratory values (hematology, blood chemistry or urinalysis) which define a disease or condition, which in the opinion of the investigator may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate and complete the study. Should there be a laboratory value which, upon initial screening, is substantially outside the normal range, the test should be repeated.
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 | Drug | – |
Primary outcome
Change in HbA1C from baseline to Week 26.
1 secondary outcome
Incidence of hypoglycemia.
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 19 Jun 2008.
- Related InfoLink provided by the sponsor.
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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.
ICD CSD 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 3 study testing Glimepiride in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Sanofi at 1 site in United States.
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 9 inclusion and 16 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 19 Jun 2008. 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 United States. 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 from baseline to Week 26.. 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 19 Jun 2008.