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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00768105
First received: October 6, 2008
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  Purpose

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


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: Factorial Assignment
Masking: Single Blind (Subject)
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 Insulin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables 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 ]

Estimated Enrollment: 24
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD1656
Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days.
Placebo Comparator: 2 Drug: Placebo
Dosing to match AZD1656

  Eligibility

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

Inclusion Criteria:

  • Female with non child-bearing potential
  • Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.
  • HbA1c below or equal to 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: NCT00768105

Locations
United States, California
Research Site
Chula Vista, California, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Klas Malmberg, MD, PhD AstraZeneca R&D Mölndal
Principal Investigator: Marcus Hompesch, MD Profil Institut for Clinical Research Inc.
  More Information

No publications provided

Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00768105     History of Changes
Other Study ID Numbers: D1020C00014
Study First Received: October 6, 2008
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013