AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3NCT00924573

Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride

A Phase 3 study testing Metformin and Glimepiride (HOE490) in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary objective of this study is to confirm the efficacy of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change. Secondary objectives of this study is to evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other… Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Metformin and Glimepiride (HOE490)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
189 participants
Where
1 siteJapan
Study dates
May 2009to Mar 2010
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 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 Diabetes Mellitus patients treated with constant dose of glimepiride on top of diet and exercise
  • Patients who gave informed consent to participate in the study

Who cannot join

  • Patients with HbA1c of < 7.0 % and > 11.0 %
  • Patients with any following laboratory test abnormality :
  • ALT and/or AST: > 3 X ULN
  • Neutrophils: < 1,000/mm3 and/or platelets < 100,000/mm3
  • Hemoglobin: <11 g/dL
  • Creatinine: >= 1.3 mg/dL in case of male or >= 1.0 mg/dL in case of female
  • 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.

Japan1 site

  • Sanofi-Aventis Administrative Office

    Tokyo

Other trials in Japan

About this study

Official title: Double-blinded Comparative Study to Investigate the Efficacy and Safety of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride in Patients With T2DM Inadequately Treated With Constant Dose of Glimepiride

Primary objective of this study is to confirm the efficacy of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change.

Secondary objectives of this study is to evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters

Read the detailed description

Patients treated with 2-6mg/day of glimepiride will be recruited. The study period consists of screening phase of 6 weeks and double-blinded phase of 24 weeks.

Being tested
Metformin, placebo, Glimepiride (HOE490)
Keywords
Glimepiride, Metformin, Combination Drug Therapy
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.

  • MetforminDrug

    oral administration

  • placeboDrug

    oral administration

  • Glimepiride (HOE490)Drug

    oral administration

Study groups in NCT00924573
Study groupRoleWhat they receive
1ExperimentalMetformin on top of glimepiride Twice a day with 2-6 mg of daily dose for glimepiride and 500-750mg of daily dose for metformin for 24 weeks
Receives: Drug: Metformin; Drug: Glimepiride (HOE490)
2Placebo comparatorPlacebo on top of glimepiride Twice a day with 2-6 mg of daily dose for glimepiride and 2-3 tablets of placebo for 24 weeks
Receives: Drug: placebo; Drug: Glimepiride (HOE490)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in HbA1c from baseline

    Measured: 24 weeks

Secondary outcomes (1)

  1. Change in the ratio patients with < 7.0% of HbA1c

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

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
Who is masked
Participant, Investigator
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00924573
Sponsor's protocol ID
EFC10846
Other IDs
HOE490/4045
Status last verified
Aug 2011
First submitted
18 Jun 2009
Last updated
31 Aug 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin and Glimepiride (HOE490) in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Japan.

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 31 Aug 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 Japan. 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. Some participants in this study may receive a placebo. 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?

Changes in HbA1c from baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00924573.

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 Aug 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in