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A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes (MAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00747175
First received: September 3, 2008
Last updated: December 2, 2010
Last verified: December 2010
  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

Condition Intervention Phase
Type 2 Diabetes Drug: AZD1656 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in T2DM Subjects

Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 52
Study Start Date: August 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group)
Drug: AZD1656
Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment
Experimental: 2
Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)
Drug: AZD1656
Dose titration of oral suspension to a tolerable dose, 1 month treatment

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation >1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
  • Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
  • HbA1c ≤10.5 % 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 ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
  • Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747175

Locations
United States, California
Research Site
Chula Vista, California, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Klas Malmberg, MD, Phd, Prof AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
Principal Investigator: Marcus Hompesch, MD Profil Institute for Clinical Research, Inc.
  More Information

Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00747175     History of Changes
Other Study ID Numbers: D1020C00002
Study First Received: September 3, 2008
Last Updated: December 2, 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

ClinicalTrials.gov processed this record on August 18, 2017