A Study of Anagliptin in patients of Diabetes.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2016/06/007029
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 260
GenderMale and Female
•Patient is willing to participate in the study and signed the
informed consent.
•Male and female, age at screening: 18 years to 65 years
Patient with diagnosis of type 2 diabetes mellitus prior to visit 1
•Body mass index (BMI) between 23 kg/m2 to 45 kg/m2 (at visit 1
•Previously treated with metformin monotherapy plus diet
modifications and exercise.
•Inadequately controlled diabetes:
i.HbA1c: 7.5% to 9.5%
ii.ii. Fasting Plasma Glucose: less than or equal to 200 mg/dL (11.1 mmol/L)
1. Sex and Reproductive Status
a. Women who are pregnant or lactating. or of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
2. Target Disease Status
a. Patient with a history of type 1 diabetes, diabetes that is a result of pancreatic injury or secondary forms of diabetes
b. Acute metabolic diabetic complications within past 3 months
c. Patient with history of 3 episodes of hypoglycemia within past 6 months which were clinically significant requiring hospitalization or third party assistance.
3. Medical History and Concurrent Diseases
Clinically significant medical condition that, might place the patient at unacceptable risk for participation in this study at visit 1 (screening)
4. Physical and Laboratory Test Findings
a. Patient with uncontrolled hypertension
b. Patient with any laboratory test results that might place the patient at unacceptable risk for participation in this
study.
5. Allergies
a. Patient with hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor or pioglitazone or any of
their component.
6. Prohibited Treatment and/or Therapies
History of treatment or currently being treated or is expected to require or undergo treatment with any of the treatment excluded medications including insulin, oral antidiabetic drugs, anti-obesity drugs etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on-inferiority of the reduction in HbA1c level adjusted for baseline HbA1c from baseline to week 16 between both the groups.Timepoint: Baseline to week 16
- Secondary Outcome Measures
Name Time Method Proportion of responders as per individual predefined criteria <br/ ><br>o HbA1c value â?¤6.5% at week 16 <br/ ><br>o HbA1c value â?¤7.0% at week 16 <br/ ><br>o HbA1c absolute reduction of â?¥1.0% from baseline to week 16 <br/ ><br>o HbA1c absolute reduction of â?¥0.7% from baseline to week 16 <br/ ><br>o HbA1c absolute reduction of â?¥0.5% from baseline to week 16 <br/ ><br> <br/ ><br>Timepoint: Baseline to week 16