Diabetes Mellitus, Type 2GLORYNCT01915264
GLucobay M - Evaluation Of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice
An observational study of Diabetes Mellitus, Type 2, run by Bayer.
Trial summary
The study is designed as non interventional to collect data on the safety especially, severe hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of acarbose/metformin fixed-dose combination under real-life treatment condition in large sample of type-2 diabetes patients in India. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Acarbose/Metformin (Glucobay M, BAY81-9783)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Mar 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 2 diabetes
Who may be able to join
- Patient will be enrolled after the decision to administer acarbose/metformin fixed dose combination for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and patient needs.
- Willing to give informed consent for participating in this study
Who cannot join
- Patients receiving anti-diabetic medication other than acarbose, or metformin monotherapy at the time of enrollment in the study will be excluded. However, during observation period, any additional anti-diabetics medication administered by the attending physician will be allowed \& recorded in case record form.
- Patient receiving acarbose/metformin fixed dose combination during 3-months prior to enrollment.
- Exclusion criteria should be read in conjunction with local product information
About this study
Official title: Glucobay M - Evaluation of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice
The study is designed as non interventional to collect data on the safety especially, severe hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of acarbose/metformin fixed-dose combination under real-life treatment condition in large sample of type-2 diabetes patients in India. The study objective is to evaluate severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events. The study will begin after the study approval by ethics committee. All patients with type 2 diabetes on acarbose or metformin monotherapy and prescribed Glucobay M will be included in study after taking the informed consent. Patients will be observed for up to 24 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose etc. The study is planned to enroll 10000 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Acarbose/Metformin (Glucobay M, BAY81-9783)
- Keywords
- Diabetes Mellitus, Type 2 Diabetes, Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acarbose/Metformin (Glucobay M, BAY81-9783)Drug
Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Acarbose/Metformin (Glucobay M, BAY81-9783) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events
Measured: 24 weeks
Secondary outcomes (10)
Incidence of adverse events other than hypoglycemia reported
Measured: 24 weeks
Mean change in HbA1c level
Measured: baseline and 24 weeks
Mean change in fasting blood sugar
Measured: baseline and 24 weeks
Mean change in postprandial blood sugar
Measured: baseline and 24 weeks
Mean change in body weight
Measured: baseline and 24 weeks
Mean change in serum LDL(low-density lipoprotein) cholesterol
Measured: baseline and 24 weeks
Mean change in serum triglyceride
Measured: baseline and 24 weeks
Mean change in serum HDL (High density lipoproteins) cholesterol
Measured: baseline and 24 weeks
Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale
Measured: baseline and 24 weeks
Number of patient with adverse event (Tolerability)
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startAug 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
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 BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915264
- Sponsor's protocol ID
- 16445
- Other IDs
- GB1310IN
- Acronym
- GLORY
- Status last verified
- Mar 2016
- First submitted
- 25 Jul 2013
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucobay M - Evaluation of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice
- ClinicalTrials.gov ID
- NCT01915264
- Acronym / sponsor ID
- GLORY / 16445
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2 Diabetes, Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 2 Aug 2013 (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 study is designed as non interventional to collect data on the safety especially, severe hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of acarbose/metformin fixed-dose combination under real-life treatment condition in large sample of type-2 diabetes patients in India. The study objective is to evaluate severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events. The study will begin after the study approval by ethics committee. All patients with type 2 diabetes on acarbose or metformin monotherapy and prescribed Glucobay M will be included in study after taking the informed consent. Patients will be observed for up to 24 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose etc. The study is planned to enroll 10000 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Acarbose/Metformin (Glucobay M, BAY81-9783) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetes
Key inclusion criteria (2 listed)
- Patient will be enrolled after the decision to administer acarbose/metformin fixed dose combination for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and patient needs.
- Willing to give informed consent for participating in this study
Key exclusion criteria (3 listed)
- Patients receiving anti-diabetic medication other than acarbose, or metformin monotherapy at the time of enrollment in the study will be excluded. However, during observation period, any additional anti-diabetics medication administered by the attending physician will be allowed \& recorded in case record form.
- Patient receiving acarbose/metformin fixed dose combination during 3-months prior to enrollment.
- Exclusion criteria should be read in conjunction with local product information
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 |
|---|---|---|
| Acarbose/Metformin (Glucobay M, BAY81-9783)Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination. | Drug | Group 1 |
Primary outcome
Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events
Time frame: 24 weeks
10 secondary outcomes
Incidence of adverse events other than hypoglycemia reported
Time frame: 24 weeks
Mean change in HbA1c level
Time frame: baseline and 24 weeks
Mean change in fasting blood sugar
Time frame: baseline and 24 weeks
Mean change in postprandial blood sugar
Time frame: baseline and 24 weeks
Mean change in body weight
Time frame: baseline and 24 weeks
Mean change in serum LDL(low-density lipoprotein) cholesterol
Time frame: baseline and 24 weeks
Mean change in serum triglyceride
Time frame: baseline and 24 weeks
Mean change in serum HDL (High density lipoproteins) cholesterol
Time frame: baseline and 24 weeks
Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale
Time frame: baseline and 24 weeks
Number of patient with adverse event (Tolerability)
Time frame: Baseline and 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
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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.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Bayer.
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 3 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: withdrawn, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events (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 25 Apr 2016.