To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Metformin

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00774553
First received: October 16, 2008
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to assess safety and tolerablility of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of metformin.


Condition Intervention Phase
Type 2 Diabetes
Drug: AZD1656
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Subjects With T2DM Treated With Metformin

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG) [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]
  • Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: October 2008
Study Completion Date: January 2010
Arms Assigned Interventions
Experimental: 1
AZD1656
Drug: AZD1656
Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.
Placebo Comparator: 2
Placebo
Drug: Placebo
Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female (with non child-bearing potential)
  • Diagnosed diabetes Mellitus patients treated with metformin alone or one other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.t
  • HbA1c <11 % at screening (HbA1c value according to international DCCT standard)

Exclusion Criteria:

  • Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
  • History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
  • Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774553

Locations
United States, Texas
Research Site
San Antonio, Texas, United States
India
Research site
Ahmedabad, India
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Klas Malmberg, MD, PhD, Prof., AstraZeneca R&D Mölndal
Principal Investigator: Dr Emanuel DeNoia, MD Healthcare Discoveries LLC Icon Development Solutions
Principal Investigator: Sanjay Sharma, MD Veeda Clinical Research Pvt. Ltd
  More Information

No publications provided

Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00774553     History of Changes
Other Study ID Numbers: D1020C00015
Study First Received: October 16, 2008
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration
India: Ministry of Health

Keywords provided by AstraZeneca:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014