A Randomized, Double Blind, Double Dummy, Comparative, Prospective, Multicenter, Parallel Study to assess Efficacy, Safety and Tolerability of Fixed Dose Combination of Teneligliptin and Metformin Tablet Compared with Metformin monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone.

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 378 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patients age >=18 and <=65 years inclusive of either sex willing to give their written informed consent and comply with the protocol requirements.
•2. Patients with Type 2 Diabetes Mellitus who have been treated with upto 1 gram per day of Metformin monotherapy for at least 3 months prior to screening and having inadequate glycaemic control [Glycosylated Haemoglobin (HbA1c) levels of >7% to <= 9%].

•1. Pregnant or lactating women.
•2. Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
•3. Patient with Type 1 diabetes mellitus or secondary form of diabetes.
•4. Patients with known hypersensitivity to any of the components of the formulation.
•5. Known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe Peripheral Neuropathy, Symptomatic Orthostatic Hypotension, Urinary Retention, Foot ulcers, or Gastric Stasis.
•6. Patients who have a recent history or who are currently known to abuse alcohol or drugs.
•7. Patients with clinically significant renal, hepatic, or cerebrovascular disease, known pituitary or gastric dysfunction, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, collagen disorders, severe infection etc. or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
•8. Patients receiving treatment with systemic corticosteroids.
•9. Patients who have participated in any clinical trial in the past 1 month.
•10. Any other condition that in the opinion of the Investigator that does not justify the patientâ??s participation in the study.

发起方

Glenmark Pharmaceuticals Ltd