Type 2 Diabetes MellitusPhase 2NCT01152385

Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients

A Phase 2 study testing AZD1656 in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: AZD1656
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 224 participants
Where: 3 sitesJapan
Study dates: May 2010to May 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Research Site
Osaka
Research Site
Suita
Research Site
Tokyo

Other trials in Japan

About this study

Official title: A 4-month Treatment, Randomized, Double-blind, Placebo-Controlled, Multi-centre, Parallel-Group Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of Different Dosing Regimens of AZD1656 as Monotherapy in Japanese Type 2 Diabetes Mellitus Patients

Conditions: Type 2 Diabetes Mellitus
Being tested: AZD1656, Placebo
Keywords: Type 2 diabetes mellitus, Japanese, phase 2, AZD1656, efficacy, dose regimen, pharmacokinetics
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD1656Drug
Oral tablet administered twice daily during 4 months
PlaceboDrug
administered twice daily during 4 months

Study groups in NCT01152385
Study group	Role	What they receive
high	Experimental	AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose) Receives: Drug: AZD1656
Middle	Experimental	AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose) Receives: Drug: AZD1656
low	Experimental	AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose) Receives: Drug: AZD1656
4	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Haemoglobin A1c (HbA1c)
Measured: from baseline to 4 months

Secondary outcomes (7)

Change in Fasting Plasma Glucose (FPG)
Measured: from baseline to 4 months
Number of Responders in Terms of HbA1C ≤ 7%
Measured: at 4th month
Number of Responders in Terms of HbA1C ≤ 6.5%
Measured: at 4th month
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)
Measured: from baseline to 4 months
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)
Measured: from baseline to 4 months
Percentage Change in Triglycerides
Measured: from baseline to 4 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Measured: from baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010May 2011

First posted29 Jun 2010 (estimated)
Study startMay 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01152385
Sponsor's protocol ID: D1020C00016
Status last verified: Jul 2012
First submitted: 10 Jun 2010
Last updated: 27 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23522182

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-month Treatment, Randomized, Double-blind, Placebo-Controlled, Multi-centre, Parallel-Group Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of Different Dosing Regimens of AZD1656 as Monotherapy in Japanese Type 2 Diabetes Mellitus Patients
ClinicalTrials.gov ID: NCT01152385
Acronym / sponsor ID: D1020C00016
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus, Japanese, phase 2, AZD1656, efficacy, dose regimen, pharmacokinetics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 29 Jun 2010 (estimated)
Results: Posted 27 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
high	Experimental	Drug: AZD1656AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
Middle	Experimental	Drug: AZD1656AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
low	Experimental	Drug: AZD1656AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
4	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD1656Oral tablet administered twice daily during 4 months	Drug	Middle, high, low
Placeboadministered twice daily during 4 months	Drug	4

Primary outcome

Change in Haemoglobin A1c (HbA1c)
Time frame: from baseline to 4 months

7 secondary outcomes

Change in Fasting Plasma Glucose (FPG)
Time frame: from baseline to 4 months
Number of Responders in Terms of HbA1C ≤ 7%
Time frame: at 4th month
Number of Responders in Terms of HbA1C ≤ 6.5%
Time frame: at 4th month
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: from baseline to 4 months
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: from baseline to 4 months
Percentage Change in Triglycerides
Time frame: from baseline to 4 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: from baseline to 4 months

Results and safety

Results posted to the registry on 27 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Dose	55	46
Middle Dose	58	52
Low Dose	56	51
Placebo	55	50

Primary outcome: Change in Haemoglobin A1c (HbA1c)

Time frame: from baseline to 4 months. Mean (Standard Deviation). Unit: Percentage

Measure	Arm 1 - High Dose n = 55	Arm 2 - Middle Dose n = 58	Arm 3 - Low Dose n = 54	Arm 4 - Placebo Dose n = 55
Value	0.0 (1.2)	-0.3 (1.3)	0.1 (1.2)	0.2 (0.7)

Population analysed: The analysis population was prior to rescue treatment (FAS)

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Dose	0 of 22 (0%)	16 of 55 (29.1%)	Not reported
Middle Dose	0 of 23 (0%)	19 of 58 (32.8%)	Not reported
Low Dose	0 of 28 (0%)	16 of 56 (28.6%)	Not reported
Placebo	0 of 23 (0%)	16 of 55 (29.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23522182Kiyosue 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.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria Leonsson-Zachrisson study director

AstraZeneca

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1656 in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Haemoglobin A1c (HbA1c) (time frame: from baseline to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01152385, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2012.