A Study of Anagliptin in patients of Diabetes.

Phase 3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2016/06/007029
• Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary

Type 2 diabetes mellitus usually requires multiple antihyperglycemic agents (AHAs) to attain or maintain glycaemic control. Metformin is widely accepted as the first line oral agent in the treatment of type 2 diabetes mellitus.

American Diabetes Association & European Association for the Study of Diabetes, American Association of Clinical Endocrinologists & American College of Endocrinology’s most recent treatment algorithm for type 2 diabetes, place metformin as the cornerstone of combination therapy, but also include new classes of drugs to consider after metformin, with an emphasis on keeping hypoglycaemia and weight gain to a minimum. Such effects are of particular importance because excess bodyweight and drug-associated hypoglycaemia are continuing concerns for many patients with type 2 diabetes. These new treatments, which include GLP-1 receptor agonists and DPP-4 inhibitors, not only improve glycaemic control, but could also positively affect some of the metabolic abnormalities associated with type 2 diabetes, including obesity, hypertension, and dyslipidemia.

Anagliptin is an oral, DPP-4 inhibitor licensed in 2012 in Japan that improves glycaemic control by preventing the rapid degradation of incretin hormones, with a resulting glucose dependent increase in stimulation of insulin secretion and inhibition of glucagon secretion. HbA1c reductions ranging from 0.6%-0.88%, with a low risk of hypoglycaemia and no weight gain, were reported when anagliptin was given either alone or in combination with metformin in patients with type 2 diabetes.

The aim of the present study is to assess the efficacy and the safety of anagliptin compared with a commonly used antidiabetic drug- pioglitazone as second-line treatment in participants with type 2 diabetes mellitus inadequately controlled on metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-09
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 260

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.
• 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.
• Allergies a.
• Patient with hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor or pioglitazone or any of their component.
• 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
Non-inferiority of the reduction in HbA1c level adjusted for baseline HbA1c from baseline to week 16 between both the groups.	Baseline to week 16

Secondary Outcome Measures

Name	Time	Method
Proportion of responders as per individual predefined criteria	o HbA1c value ≤6.5% at week 16

Trial Locations

Locations (20)

KIMS Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Mysore Medical College & Research Institute, K.R. Hospital; 🇮🇳 Mysore, KARNATAKA, India

Ajanta Research Centre, Ajanta Hospital & IVF Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

B J Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Diacon Hospital (Diabetes Care & Research Centre); 🇮🇳 Bangalore, KARNATAKA, India

Enternal Heart Care Centre & Research Institute Pvt. Ltd.; 🇮🇳 Jaipur, RAJASTHAN, India

Government Medical College & Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Kasturba Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Nirmal Hospital; 🇮🇳 Jhansi, UTTAR PRADESH, India

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KIMS Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Yogitha C

Principal investigator

9428854442

yogitha.c10@rediffmail.com