Type 2 DiabetesPhase 3NCT01257334
Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
A Phase 3 study testing BI 10773 in people with Type 2 Diabetes, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- BI 10773
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,390 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to Jul 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus prior to informed consent
- Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.
- Minimum dose for metformin:
- ≥1500 mg/day or
- maximum tolerated dose or
- maximum dose according to local label
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- Minimum dose for sulfonylurea:
- ≥half of the maximal recommended dose or
- maximum tolerated dose or
- maximum dose according to local label
- HbA1c of ≥ 7.0% and ≤ 10% at Visit 1 (screening) in order to be eligible for randomized treatment. HbA1c of > 10% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
- Age ≥ 18
- BMI ≤ 45 kg/m2 (BodyMass Index) at Visit 1 (Screening)
- Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation
Who cannot join
- Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
- Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
- Acute coronary syndrome including myocardial infarction, stroke or TIA within 3 months prior to informed consent
- Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT),or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
- Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase
- Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
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- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
- Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy
- Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g.malaria, babesiosis, haemolytic anaemia)
- Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
- Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2D
- Pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential and are not practicing an acceptable method of birthcontrol, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
- Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
- Participation in another trial with an investigational drug within 30 days prior to informed consent
- Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control.
Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled patients (HbA1c > 10%)
Read the detailed description
Concomitant medications, including other treatments used to treat intercurrent medical conditions during the treatment period, will be recorded on the CRFs. This record will include the name of the medication, frequency, unit dose, dosage, the date when the drug is started and stopped, and the indication for the use of the drug.
Prohibited
The following treatments are prohibited in the trial
- Other antidiabetic agents except for the background therapy (metformin or the combination of metformin plus sulfonylurea)
- Treatment with anti-obesity drugs or systemic steroids
- Other investigational medications
- Conditions
- Type 2 Diabetes
- Being tested
- BI 10773
- Keywords
- type 2 diabetes
- 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.
BI 10773Drug
patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | BI 10773 10 mg, 25 mg administered once daily Receives: Drug: BI 10773 |
| Control Group | Placebo comparator | Placebo administered once daily Receives: Drug: BI 10773 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline in 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.
- First posted9 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 1,390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ting-I Lee, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257334
- Sponsor's protocol ID
- 99050
- Status last verified
- Dec 2010
- First submitted
- 8 Dec 2010
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
- ClinicalTrials.gov ID
- NCT01257334
- Acronym / sponsor ID
- 99050
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,390 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Dec 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.
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control.
Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled patients (HbA1c > 10%)
Detailed description
Concomitant medications, including other treatments used to treat intercurrent medical conditions during the treatment period, will be recorded on the CRFs. This record will include the name of the medication, frequency, unit dose, dosage, the date when the drug is started and stopped, and the indication for the use of the drug.
Prohibited
The following treatments are prohibited in the trial
- Other antidiabetic agents except for the background therapy (metformin or the combination of metformin plus sulfonylurea)
- Treatment with anti-obesity drugs or systemic steroids
- Other investigational medications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: BI 10773BI 10773 10 mg, 25 mg administered once daily |
| Control Group | Placebo comparator | Drug: BI 10773Placebo administered once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of type 2 diabetes mellitus prior to informed consent
- Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.
- HbA1c of ≥ 7.0% and ≤ 10% at Visit 1 (screening) in order to be eligible for randomized treatment. HbA1c of > 10% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
- Age ≥ 18
- BMI ≤ 45 kg/m2 (BodyMass Index) at Visit 1 (Screening)
Key exclusion criteria (17 listed)
- Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
- Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
- Acute coronary syndrome including myocardial infarction, stroke or TIA within 3 months prior to informed consent
- Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT),or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
- Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase
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 |
|---|---|---|
| BI 10773patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea | Drug | Control Group, Treatment Group |
Primary outcome
the change from baseline in HbA1c
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
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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.
Ting-I Lee principal investigator
Taipei Medical University WanFang Hospital
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 BI 10773 in people with Type 2 Diabetes, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 14 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 9 Dec 2010. 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 Taiwan. 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?
Results are not available in the source record.
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?
the change from baseline in HbA1c (time frame: 24 weeks). 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 9 Dec 2010.