Study of Safety and Efficacy Of PF-04971729 In Patients With Type 2 Diabetes And Hypertension

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2Hypertension

• Registration Number: CTRI/2010/091/001073
• Lead Sponsor: Pfizer Limited

Brief Summary

This is a 4 week, phase 2, randomized, double- blind, placebo-controlled, dose-ranging, parallel group study to evaluate the safety, tolerability and efficacy of once daily PF-04971729 and hydrochlorothiazide  In patients with type 2 diabetes mellitus with inadequate glycemic and blood pressure control. The primary objective is to evaluate the dose-response of PF-04971729 administered once daily for 4-weeks in adults with T2DM on systolic blood pressure (SBP). The study employed 24hr ambulatory blood pressure monitoring device.  xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

 Subject visits completed, site close outs will be completed by end of April 2011

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-18
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 175

Inclusion Criteria

Ages Eligible for Study: 18 Years to 65 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No 1.Patients with type 2 diabetes and hypertension 2.Medically stable 3.On at least 1 (and up to 2) oral diabetes drugs 4.And up to 2 medicines for blood pressure control.

Exclusion Criteria

1.Patients with type 1 diabetes 2.Heart attack 3.Stroke 4.Uncontrolled blood pressure 5.Significant kidney disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Placebo-adjusted, change from baseline on average, 24 hour systolic blood pressure (SBP) on Day 28 assessed using 24 hour ambulatory blood pressure monitoring (ABPM)	28 Days

Secondary Outcome Measures

Name	Time	Method
Placebo adjusted, change from baseline in fasting plasma glucose	28 Days
Placebo-adjusted, change from baseline on average, daytime, night time and 24 hour SBP, DBP, pulse rate on Day 28 using 24 hour ABPM	28 Days
Assessment of clinical safety-related laboratory tests, 12 lead electrocardiograms (ECG), adverse events/serious adverse events including urinary tract and genital fungal infections, hypo- and hyper- glycemia as well as hypo- and hyper tension	28 Days
Placebo-adjusted, change from baseline on average, daytime, night time and 24-hour diastolic blood pressure (DBP), and pulse rate on Day 28 using 24 hour ABPM	28 Days
Placebo-adjusted, change from baseline on average daytime, night time SBP using 24 hour ABPM	28 Days
Placebo-adjusted, change from baseline on 24 hour urinary glucose excretion on Day 28	28 Days
Placebo-adjusted, change from baseline in trough SBP, DBP and pulse rate using automated device	28 Days

Trial Locations

Locations (9)

ACEER; 🇮🇳 Chennai, TAMIL NADU, India

Bangalore Endocrinology and Diabetes Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Bharti Research Institute of Diabetes and Endocrinology; 🇮🇳 Karnal, HARYANA, India

Chowpatty Medical Center; 🇮🇳 Mumbai, MAHARASHTRA, India

Deshmukh Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Diabetomics India Pvt Ltd; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Dr. V. Seshiah Diabetes Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Medisys Clinisearch Pvt. Ltd., Bangalore Diabetes Centre; 🇮🇳 Bangalore, KARNATAKA, India

S.R. Kalla Memorial Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

ACEER

🇮🇳Chennai, TAMIL NADU, India

Dr. Shriraam Mahadevan

Principal investigator

aceergroup@gmail.com