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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01961388
First received: October 10, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Drug: Bay G5421 Glucobay
Drug: Metformin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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%)


Secondary Outcome Measures:
  • Mean change of HbA1c [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Mean change of fasting blood glucose(FBG) [ Time Frame: Base line and 16 weeks ] [ Designated as safety issue: No ]
  • Mean change of low density lipoprotein cholesterol(LDL) [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Mean change of high density lipoprotein cholesterol(HDL) [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Mean change of total cholesterol(TC) [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Mean change of Body weight [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Mean change of triglyceride(TG) [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Compare the mean change between acarbose and metformin arm of postprandial blood glucose (PPBG) [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Compare the mean change between acarbose and metformin arm of HbA1c [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Compare the mean change between acarbose and metformin arm of FBG [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Compare the mean change between acarbose and metformin arm of LDL [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Compare the mean change between acarbose and metformin arm of HDL [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Compare the mean change between acarbose and metformin arm of TC [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Compare the mean change between acarbose and metformin arm of TG [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Compare the mean change between acarbose and metformin arm of Body weight [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change in gastrointestinal tolerability to therapy from post baseline visit to the end of observation period of up to 16 weeks [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: Yes ]
  • Incidence rate of adverse drug reactions in acarbose and metformin treated groups during 16 weeks observation period [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12250
Study Start Date: November 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Acarbose_BAY G5421
Drug: Bay G5421 Glucobay
Oral, dosage of Acarbose as per the directions of treating physician
Group 2
Metformin
Drug: Metformin
Oral, dosage of Metformin as per the directions of treating physician

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961388

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
India
Not yet recruiting
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01961388     History of Changes
Other Study ID Numbers: 16667, GB1311IN
Study First Received: October 10, 2013
Last Updated: July 28, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by Bayer:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014