NCT01152385

Brief Summary

The purpose of this study is to compare the effect on glucose control of 3 different AZD1656 dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started May 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 27, 2012

Completed
Last Updated

August 27, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

June 10, 2010

Results QC Date

July 24, 2012

Last Update Submit

July 24, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitusJapanesephase 2AZD1656efficacydose regimenpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Change in Haemoglobin A1c (HbA1c)

    from baseline to 4 months

Secondary Outcomes (7)

  • Change in Fasting Plasma Glucose (FPG)

    from baseline to 4 months

  • Number of Responders in Terms of HbA1C ≤ 7%

    at 4th month

  • Number of Responders in Terms of HbA1C ≤ 6.5%

    at 4th month

  • Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)

    from baseline to 4 months

  • Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)

    from baseline to 4 months

  • +2 more secondary outcomes

Study Arms (4)

high

EXPERIMENTAL

AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)

Drug: AZD1656

Middle

EXPERIMENTAL

AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)

Drug: AZD1656

low

EXPERIMENTAL

AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)

Drug: AZD1656

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD1656DRUG

Oral tablet administered twice daily during 4 months

Middlehighlow
PlaceboDRUG

administered twice daily during 4 months

4

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women of non-childbearing potential.
  • Provision of informed consent prior to any study specific procedures
  • Naïve T2DM patients with HbA1c ≥ 7.5% but ≤ 10% or T2DM Patients treated with one or two oral anti-hyperglycaemic agent(s) with HbA1c ≥ 7.5% but ≤ 9.5% at enrolment visit (Visit1)

You may not qualify if:

  • Clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, hepatic disease and haematological disease.
  • The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
  • Participation in another clinical trial and/or intake of another investigational drug within the last 30 days prior to enrolment visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Osaka, Japan

Location

Research Site

Suita, Japan

Location

Research Site

Tokyo, Japan

Location

Related Publications (1)

  • Kiyosue A, Hayashi N, Komori H, Leonsson-Zachrisson M, Johnsson E. Dose-ranging study with the glucokinase activator AZD1656 as monotherapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2013 Oct;15(10):923-30. doi: 10.1111/dom.12100. Epub 2013 Apr 22.

    PMID: 23522182DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AZD1656

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com
+44 1625 518062

Study Officials

  • Maria Leonsson-Zachrisson

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 29, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 27, 2012

Results First Posted

August 27, 2012

Record last verified: 2012-07

Locations

JP(3)