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CompletedNCT00747175MADUpdated Dec 3, 2010

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

A Phase 1 interventional study of AZD1656 and AZD1656 in Type 2 Diabetes, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-12-03.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Type 2 diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 52 is below the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
52 participants (estimated)

Study arms

  • 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

  • Experimental
    2

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

    Drug: AZD1656

Interventions

  • DrugAZD1656

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

  • DrugAZD1656

    Dose titration of oral suspension to a tolerable dose, 1 month treatment

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  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

07

Study locations

1 site
  • Research Site
    Chula Vista, California, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00747175
Lead sponsor
AstraZeneca
First posted
Sep 4, 2008
Start date
Aug 2008
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Dec 3, 2010

Study contacts

Klas Malmberg, MD, Phd, Prof
study director · AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
Marcus Hompesch, MD
principal investigator · Profil Institute for Clinical Research, Inc.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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