Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
BI 10773
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Taipei Medical University - WanFang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group
Control Group
Arm Description
BI 10773 10 mg, 25 mg administered once daily
Placebo administered once daily
Outcomes
Primary Outcome Measures
the change from baseline in HbA1c
Secondary Outcome Measures
Full Information
NCT ID
NCT01257334
First Posted
December 8, 2010
Last Updated
December 8, 2010
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01257334
Brief Title
Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
BI 10773 10 mg, 25 mg administered once daily
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Placebo administered once daily
Intervention Type
Drug
Intervention Name(s)
BI 10773
Intervention Description
patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea
Primary Outcome Measure Information:
Title
the change from baseline in HbA1c
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting-I Lee
Organizational Affiliation
Taipei Medical University WanFang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University - WanFang Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
We'll reach out to this number within 24 hrs