Sparsh Prospective Study
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2016/04/006868
- Lead Sponsor
- MSD Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
A subject must meet all the criteria listed below to participate in the trial.
1.Subject must be willing and able to provide written informed consent for the trial
2.Subject must be aged between 18-65 years (both inclusive). A subject may be of either gender, any race/ethnicity.
3.Subject must be a known patient of type 2 diabetes and being treated with Januvia/Janumet agents on out-patient basis.
4.Subject must have an HbA1c value of
7% to 8 % on screening
5.Subject must have results of a physical examination, including blood pressure, within clinically acceptable limits to the investigator/sponsor
•SBP- less than 200 mm Hg
•DBP- less than 120 mm Hg
•BMI- between (and including) 18-30
6.Subject must be able to adhere to requirements of this study protocol
A subject meeting any of the exclusion criteria listed below must be excluded from participating in the trial:
1.Subject is currently on or has received Insulin 12 weeks prior to screening
2.Subject currently prescribed glinides
3.Subject is already enrolled at the time of screening or planning to get enrolled in any other regular diabetes education/counseling program
4.Subject is unlikely to comprehend or adhere to lifestyle advice delivered, for reasons of serious co-morbid condition or debilitating disease or neuro-psychiatric illness
5.Subject has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
•Patients with life expectancy of less than 12 months
•Patients with type I DM
•Gestational Diabetes
•Lactation
•Hypersensitivity to Sitagliptin
•Known case or patients with pancreatitis
6.Subject who has participated in any other clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial.
7.Subject or a family member is among the personnel of the investigational or sponsor staff directly involved with this trial.
8.Subject is not on same diabetes treatment for less than 3 month.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline to 52 weeks between the two arms.Timepoint: 52 weeks
- Secondary Outcome Measures
Name Time Method Clinical <br/ ><br>Change in baseline from 52 weeks between the two arms for the following parameters - <br/ ><br>1.Body Mass Index (BMI) <br/ ><br>2.Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) <br/ ><br>3.Serum LDL Cholesterol (LDL-C) <br/ ><br>4.Serum HDL Cholesterol (HDL-C) <br/ ><br>5.Serum Total Cholesterol (TC) <br/ ><br>6.Serum Triglycerides (TG) <br/ ><br>Behavioral <br/ ><br>1.Dietary Parameters: <br/ ><br>2.Lifestyle Parameters: <br/ ><br>3.Compliance Parameters: <br/ ><br>Timepoint: 52 Weeks