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

NCT00747175 | Completed Phase 1

• 1 other identifier: D1020C00002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)

  Blood samples taken repeatedly during 24 hours on study day sessions

Secondary Outcomes (2)

• Pharmacokinetic variables

  Blood samples taken repeatedly during 24 hours on study day sessions

• Pharmacodynamic variables

  Blood samples taken repeatedly during 24 hours on study day sessions

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)

Drug: AZD1656

Interventions

AZD1656 DRUG

Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment

1

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Chula Vista, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AZD1656

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Klas Malmberg, MD, Phd, Prof

  AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden

  STUDY DIRECTOR

• Marcus Hompesch, MD

  Profil Institute for Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 3, 2010

Record last verified: 2010-12

Locations

US (1)