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

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ClinicalTrials.gov Identifier: NCT00768105
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: AZD1656 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
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
Study Start Date : September 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ]
  2. Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

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
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases