Clinical trial NCT01961388: Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy
Official title: Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus
Keywords: Type 2 Diabetes
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-10-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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 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.


Eligibility 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

Primary outcomes:
measure: The mean change in post-meal glucose levels from baseline at the end of observation period of up to 16 weeks
timeFrame: baseline and 16 weeks
Secondary outcomes:
measure: Mean change of HbA1c
timeFrame: Baseline and 16 weeks
measure: Mean change of fasting blood glucose(FBG)
timeFrame: Base line and 16 weeks
measure: Mean change of low density lipoprotein cholesterol(LDL)
timeFrame: baseline and 16 weeks
measure: Mean change of high density lipoprotein cholesterol(HDL)
timeFrame: Baseline and 16 weeks
measure: Mean change of total cholesterol(TC)
timeFrame: baseline and 16 weeks
measure: Mean change of Body weight
timeFrame: baseline and 16 weeks
measure: Mean change of triglyceride(TG)
timeFrame: baseline and 16 weeks
measure: Compare the mean change between acarbose and metformin arm of postprandial blood glucose (PPBG)
timeFrame: baseline and 16 weeks
measure: Compare the mean change between acarbose and metformin arm of HbA1c
timeFrame: baseline and 16 weeks
measure: Compare the mean change between acarbose and metformin arm of FBG
timeFrame: baseline and 16 weeks
measure: Compare the mean change between acarbose and metformin arm of LDL
timeFrame: baseline and 16 weeks
measure: Compare the mean change between acarbose and metformin arm of HDL
timeFrame: baseline and 16 weeks
measure: Compare the mean change between acarbose and metformin arm of TC
timeFrame: baseline and 16 weeks
measure: Compare the mean change between acarbose and metformin arm of TG
timeFrame: baseline and 16 weeks
measure: Compare the mean change between acarbose and metformin arm of Body weight
timeFrame: baseline and 16 weeks
measure: Change in gastrointestinal tolerability to therapy from post baseline visit to the end of observation period of up to 16 weeks
timeFrame: baseline and 16 weeks
measure: Incidence rate of adverse drug reactions in acarbose and metformin treated groups during 16 weeks observation period
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: