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Diabetes MellitusSTARCH AMNCT01961388

Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy

An observational study of Diabetes Mellitus, run by Bayer.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study is designed as non interventional to collect data on the effectiveness of acarbose and metformin monotherapy, respectively, in terms of change from baseline in post prandial blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each carbohydrates consumption subgroup under… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Bay G5421 Glucobay and Metformin
Type of treatment
Pill or oral medicine
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2015to Jun 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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Drug-naïve sub-optimally controlled (by diet and physical exercise) type 2 diabetic patients (Female and male patients who are at least 18 years of age) selected from secondary or tertiary referral centers, private hospitals / clinic with good inflow of patients with diabetes

Who may be able to join

  • Drug-naïve (i.e., the patients should never be treated with anti-diabetic drugs before screening) patients in whom decision to administer monotherapy with either acarbose or metformin for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and medical patient needs, and who consent to participate in study will be included

Who cannot join

  • Patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded. However, during observation period, patients may receive any additional anti-diabetics medication at the decision of investigator.
  • Exclusion criteria should be read in conjunction with local product information. All contra-indications according to the local marketing authorization should be considered

About this study

The study is designed as non interventional to collect data on the effectiveness of acarbose and metformin monotherapy, respectively, in terms of change from baseline in post prandial blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each carbohydrates consumption subgroup under real-life treatment condition in large sample of type-2 diabetes patients in India. The study will begin after the study approval by ethics committee.All drug naïve patients in whom decision to administer acarbose or metformin monotherapy for type 2 diabetes management has been made will be included in study after taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll 12250 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.

Being tested
Bay G5421 Glucobay, Metformin
Keywords
Type 2 Diabetes
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bay G5421 GlucobayDrug

    Oral, dosage of Acarbose as per the directions of treating physician

  • MetforminDrug

    Oral, dosage of Metformin as per the directions of treating physician

Study groups in NCT01961388
Study groupRoleWhat they receive
Group 1Acarbose_BAY G5421
Receives: Drug: Bay G5421 Glucobay
Group 2Metformin
Receives: Drug: Metformin

What is being measured

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

  1. The mean change in post-meal glucose levels from baseline at the end of observation period of up to 16 weeks

    The primary outcome will be summarized separately in acarbose and metformin monotherapy treated patients having carbohydrates consumption (National Institute of Nutrition (NIN), India recommend50% to 60% of total calories from carbohydrates in balance diet : - Below NIN recommendation (< 50%) - As per NIN recommendation (50% to 60%) - Above NIN recommendation (> 60%)

    Measured: baseline and 16 weeks

Secondary outcomes (17)

  1. Mean change of HbA1c

    Measured: Baseline and 16 weeks

  2. Mean change of fasting blood glucose(FBG)

    Measured: Base line and 16 weeks

  3. Mean change of low density lipoprotein cholesterol(LDL)

    Measured: baseline and 16 weeks

  4. Mean change of high density lipoprotein cholesterol(HDL)

    Measured: Baseline and 16 weeks

  5. Mean change of total cholesterol(TC)

    Measured: baseline and 16 weeks

  6. Mean change of Body weight

    Measured: baseline and 16 weeks

  7. Mean change of triglyceride(TG)

    Measured: baseline and 16 weeks

  8. Compare the mean change between acarbose and metformin arm of postprandial blood glucose (PPBG)

    Measured: baseline and 16 weeks

  9. Compare the mean change between acarbose and metformin arm of HbA1c

    Measured: baseline and 16 weeks

  10. Compare the mean change between acarbose and metformin arm of FBG

    Measured: baseline and 16 weeks

  11. Compare the mean change between acarbose and metformin arm of LDL

    Measured: baseline and 16 weeks

  12. Compare the mean change between acarbose and metformin arm of HDL

    Measured: baseline and 16 weeks

  13. Compare the mean change between acarbose and metformin arm of TC

    Measured: baseline and 16 weeks

  14. Compare the mean change between acarbose and metformin arm of TG

    Measured: baseline and 16 weeks

  15. Compare the mean change between acarbose and metformin arm of Body weight

    Measured: baseline and 16 weeks

  16. Change in gastrointestinal tolerability to therapy from post baseline visit to the end of observation period of up to 16 weeks

    Measured: baseline and 16 weeks

  17. Incidence rate of adverse drug reactions in acarbose and metformin treated groups during 16 weeks observation period

    Measured: 16 weeks

Timeline

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

  1. First posted11 Oct 2013 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01961388
Sponsor's protocol ID
16667
Other IDs
GB1311IN
Acronym
STARCH AM
Status last verified
Mar 2016
First submitted
10 Oct 2013
Last updated
15 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, 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 1 inclusion and 2 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 15 Jun 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?

The mean change in post-meal glucose levels from baseline at the end of observation period of up to 16 weeks (time frame: baseline and 16 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 NCT01961388.

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 15 Jun 2016.

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