Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Anagliptin 100 mg tablet: Dose-100 mg
Frequency-twice daily
Mode of Administration-oral
Duration of treatment-16 weeks
Control Intervention1: PIOLET 30 tablet: Dose-30 mg
Frequency-
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Gender Male 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)
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-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
| Measure | Time frame |
|---|---|
| Proportion of responders as per individual predefined criteria o HbA1c value â?¤6.5% at week 16 o HbA1c value â?¤7.0% at week 16 o HbA1c absolute reduction of â?¥1.0% from baseline to week 16 o HbA1c absolute reduction of â?¥0.7% from baseline to week 16 o HbA1c absolute reduction of â?¥0.5% from baseline to week 16 Timepoint: Baseline to week 16 | — |
Countries
India
Contacts
Public ContactDr Rutvj Hedamba
Lambda Therapeutic Research Ltd
Outcome results
None listed