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 September 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01961388
First received: October 10, 2013
Last updated: September 24, 2014
Last verified: September 2014

October 10, 2013
September 24, 2014
November 2014
January 2016   (final data collection date for 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 ] [ 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%)
Same as current
Complete list of historical versions of study NCT01961388 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy
Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Diabetes Mellitus
  • Drug: Bay G5421 Glucobay
    Oral, dosage of Acarbose as per the directions of treating physician
  • Drug: Metformin
    Oral, dosage of Metformin as per the directions of treating physician
  • Group 1
    Acarbose_BAY G5421
    Intervention: Drug: Bay G5421 Glucobay
  • Group 2
    Metformin
    Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12250
June 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
India
 
NCT01961388
16667, GB1311IN
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP