Type II Diabetes MellitusPhase 2NCT01020123

Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients

A Phase 2 study testing AZD1656 and Glipizide in people with Type II Diabetes Mellitus, run by AstraZeneca at 77 sites in 11 countries.

Completed

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

Official record

Search all trials

Trial summary

The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type II Diabetes Mellitus
What is being tested?: AZD1656 and Glipizide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 530 participants
Where: 77 sitesin 11 countries
Study dates: Oct 2009to Feb 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

female of non-childbearing potential
Treated with maximally tolerated dose of metformin (≥ 1500mg/day) for at least 10 weeks prior to enrolment.
Patients with HbA1c ≥ 7.5 but ≤ 10% at enrolment visit (Visit 1) can enter cohort 1.Patients with HbA1c between >10 % and <12 % can enter the open-label arm with AZD1656 (cohort 2)

Who cannot join

Significant cardiovascular event within the last 6 months prior to enrolment or heart failure New York Heart Association (NYHA) class III-IV.
Impaired renal function in terms of GFR<60 ml/min, based on Modification of Diet in Renal Disease Study Group (MDRD) calculation.
Use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14 days before randomisation.

Trial locations and contacts

77 sites in 11 countries.

Country

City, postcode or hospital

77 sites in 11 countries

Germany11 sites

Research Site
Aschaffenburg
Research Site
Berlin
Research Site
Bochum
Research Site
Brentwood, TN
Research Site
Dortmund
Research Site
Dresden, Saxony
Research Site
Frankfurt
Research Site
Görlitz
Research Site
Hamburg
Research Site
Lübeck
Research Site
Magdeburg

Other trials in Germany

Hungary11 sites

Research Site
Balatonfüred
Research Site
Békéscsaba
Research Site
Dunaújváros
Research Site
Eger
Research Site
Gyula
Research Site
Kaposvár
Research Site
Nyíregyháza
Research Site
Saint Laurent, QC
Research Site
Szekszárd
Research Site
Szigetvár
Research Site
Zalaegerszeg

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Mexico10 sites

Research Site
Aguascalientes, Aguascalientes
Research Site
Brentwood, TN
Research Site
Chiuahua
Research Site
Cuernavaca, Morelos
Research Site
Mérida, Yucatán
Research Site
Meridas, Yucatán
Research Site
Monterrey, Mexico
Research Site
Monterrey, Nuevo León
Research Site
San Luis Potosí City
Research Site
Zapopan, Jalisco

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United Kingdom9 sites

Research Site
Cardiff
Research Site
Chorley
Research Site
Glasgow
Research Site
Liverpool, Merseyside
Research Site
Paignton, Devon
Research Site
Saint Laurent, QC
Research Site
Stevenage
Research Site
West Bromwich
Research Site
West Lothian

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Latvia8 sites

Research Site
Brentwood, TN
Research Site
Daugavpils
Research Site
Jēkabpils
Research Site
Jelgava
Research Site
Limbaži
Research Site
Riga
Research Site
Talsi
Research Site
Valmiera

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Peru7 sites

Research Site
Brentwood, TN
Research Site
Callao
Research Site
Lambayeque
Research Site
Lima, Lima Province
Research Site
Lima
Research Site
Piura
Research Site
Trujillo

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Romania7 sites

Research Site
Alba Iulia, Alba
Research Site
Brentwood, TN
Research Site
Galati
Research Site
Ploieşti
Research Site
Sibiu
Research Site
Tg Mures, Mureș County
Research Site
Timișoara

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Poland5 sites

Research Site
Brentwood, TN
Research Site
Gdansk
Research Site
Krakow
Research Site
Kutno
Research Site
Wroclaw

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Chile4 sites

Research Site
Brentwood, TN
Research Site
Santiago
Research Site
Temuco, Araucania
Research Site
Temuco

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Sweden3 sites

Research Site
Brentwood, TN
Research Site
Huddinge
Research Site
Lund

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Lithuania2 sites

Research Site
Brentwood, TN
Research Site
Kaunas

Other trials in Lithuania

About this study

Official title: A 4-month, Randomized, Double-blind, Placebo- and Active-Controlled, Multi-centre, Parallel-Group Study, With an Optional 2-month Extension, to Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus Patients

The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients

Conditions: Type II Diabetes Mellitus
Being tested: AZD1656, Placebo, Glipizide
Keywords: Type II Diabetes Mellitus, metformin, glipizide
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
Different doses of AZD1656 administered to 5 groups of patients
PlaceboDrug
AZD1656 placebo and glipizide placebo administered to 1 group of patients
GlipizideDrug
Glipizide administered to 1 group of patients

Study groups in NCT01020123
Study group	Role	What they receive
1	Experimental	AZD1656 Receives: Drug: AZD1656
2	Experimental	AZD1656 Receives: Drug: AZD1656
3	Experimental	AZD1656 Receives: Drug: AZD1656
4	Experimental	AZD1656 Receives: Drug: AZD1656
5	Experimental	AZD1656 Receives: Drug: AZD1656
6	Placebo comparator	Not described Receives: Drug: Placebo
7	Active comparator	Glipizide administered to 1 group of patients Receives: Drug: Glipizide

What is being measured

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

HbA1c: Change From Baseline to 4 Month
AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue
Measured: Baseline to 4th Month

Secondary outcomes (29)

FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.
Measured: baseline to 4 month
SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.
Measured: baseline to 4 month
OGTT/Plasma Glucose
The relative change in AUC
Measured: baseline to 4 month
OGTT/Insulin
The Relative Change in AUC FAS Prior to Rescue
Measured: baseline to 4 month
OGTT/C-peptide
The relative change, FAS prior to rescue
Measured: baseline to 4 month
OGTT/Pro-insulin/Insulin
The relative change, FAS prior to rescue
Measured: baseline to 4 month
HbA1c ≤ 7
Number of responders ≤ 7, FAS prior to rescue.
Measured: baseline to 4 month
HbA1c ≤ 6.5
Number of Responders ≤ 6.5, FAS Prior to Rescue
Measured: baseline to 4 month
LDL-C: Mean Ratio
Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.
Measured: baseline to 4 month
HDL-C: Change From Baseline
Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.
Measured: baseline to 4 month
Total Cholesterol: Change From Baseline
Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.
Measured: baseline to 4 month
Triglycerides: Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
C-reactive Protein: Change From Baseline
Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI
Measured: baseline to 4 month
Systolic Blood Pressure, Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Diastolic Blood Pressure, Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Pulse, Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Weight, Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
QTcF; Electorcardiagram Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Haemoglobin; Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Leukocytes; Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Sodium; Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Potassium; Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Creatinine; Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
ALT; Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
AST; Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Alkaline Phosphatase; Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
Bilirubin; Change From Baseline
Summary statistic of change from baseline
Measured: baseline to 4 month
CL/F to Characterise the PK Properties of AZD1656.
The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given.
Measured: at 4 month
EC50 to Characterise the PD Properties of AZD1656.
The value is model based. The value is independent treatment given.
Measured: at 4 month

Timeline

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

Oct 2009Feb 2011

First posted25 Nov 2009 (estimated)
Study startOct 2009
Primary completionFeb 2011
Study completionFeb 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.
Other trials for Type II 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: 530 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01020123
Sponsor's protocol ID: D1020C00009
Status last verified: Nov 2012
First submitted: 11 Nov 2009
Last updated: 26 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 II Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-month, Randomized, Double-blind, Placebo- and Active-Controlled, Multi-centre, Parallel-Group Study, With an Optional 2-month Extension, to Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus Patients
ClinicalTrials.gov ID: NCT01020123
Acronym / sponsor ID: D1020C00009
Conditions: Type II Diabetes Mellitus
Keywords: Type II Diabetes Mellitus, metformin, glipizide
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 530 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 25 Nov 2009 (estimated)
Results: Posted 26 Nov 2012

Clinical summary

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

The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
1	Experimental	Drug: AZD1656AZD1656
2	Experimental	Drug: AZD1656AZD1656
3	Experimental	Drug: AZD1656AZD1656
4	Experimental	Drug: AZD1656AZD1656
5	Experimental	Drug: AZD1656AZD1656
6	Placebo comparator	Drug: Placebo
7	Active comparator	Drug: GlipizideGlipizide administered to 1 group of patients

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

female of non-childbearing potential
Treated with maximally tolerated dose of metformin (≥ 1500mg/day) for at least 10 weeks prior to enrolment.
Patients with HbA1c ≥ 7.5 but ≤ 10% at enrolment visit (Visit 1) can enter cohort 1.Patients with HbA1c between >10 % and <12 % can enter the open-label arm with AZD1656 (cohort 2)

Key exclusion criteria (3 listed)

Significant cardiovascular event within the last 6 months prior to enrolment or heart failure New York Heart Association (NYHA) class III-IV.
Impaired renal function in terms of GFR<60 ml/min, based on Modification of Diet in Renal Disease Study Group (MDRD) calculation.
Use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14 days before randomisation.

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
AZD1656Different doses of AZD1656 administered to 5 groups of patients	Drug	1, 2, 3, 4, 5
PlaceboAZD1656 placebo and glipizide placebo administered to 1 group of patients	Drug	6
GlipizideGlipizide administered to 1 group of patients	Drug	7

Primary outcome

HbA1c: Change From Baseline to 4 Month
Time frame: Baseline to 4th Month
AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue

29 secondary outcomes

FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
Time frame: baseline to 4 month
SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
Time frame: baseline to 4 month
OGTT/Plasma Glucose
Time frame: baseline to 4 month
OGTT/Insulin
Time frame: baseline to 4 month
OGTT/C-peptide
Time frame: baseline to 4 month
OGTT/Pro-insulin/Insulin
Time frame: baseline to 4 month
HbA1c ≤ 7
Time frame: baseline to 4 month
HbA1c ≤ 6.5
Time frame: baseline to 4 month
LDL-C: Mean Ratio
Time frame: baseline to 4 month
HDL-C: Change From Baseline
Time frame: baseline to 4 month
Total Cholesterol: Change From Baseline
Time frame: baseline to 4 month
Triglycerides: Change From Baseline
Time frame: baseline to 4 month
C-reactive Protein: Change From Baseline
Time frame: baseline to 4 month
Systolic Blood Pressure, Change From Baseline
Time frame: baseline to 4 month
Diastolic Blood Pressure, Change From Baseline
Time frame: baseline to 4 month
Pulse, Change From Baseline
Time frame: baseline to 4 month
Weight, Change From Baseline
Time frame: baseline to 4 month
QTcF; Electorcardiagram Change From Baseline
Time frame: baseline to 4 month
Haemoglobin; Change From Baseline
Time frame: baseline to 4 month
Leukocytes; Change From Baseline
Time frame: baseline to 4 month
Sodium; Change From Baseline
Time frame: baseline to 4 month
Potassium; Change From Baseline
Time frame: baseline to 4 month
Creatinine; Change From Baseline
Time frame: baseline to 4 month
ALT; Change From Baseline
Time frame: baseline to 4 month
AST; Change From Baseline
Time frame: baseline to 4 month
Alkaline Phosphatase; Change From Baseline
Time frame: baseline to 4 month
Bilirubin; Change From Baseline
Time frame: baseline to 4 month
CL/F to Characterise the PK Properties of AZD1656.
Time frame: at 4 month
EC50 to Characterise the PD Properties of AZD1656.
Time frame: at 4 month

Results and safety

Results posted to the registry on 26 Nov 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
Higher Dose	93	76
Lower Dose	91	77
40 mg Fixed Dose	52	44
20 mg Fixed Dose	40	33
Placebo	88	77
Glipizide	94	83
Open Label	72	61

Primary outcome: HbA1c: Change From Baseline to 4 Month

Time frame: Baseline to 4th Month. Mean (95% Confidence Interval). Unit: Percentage

Measure	Higher Dose n = 80	Lower Dose n = 82	40 mg Fixed Dose n = 47	20 mg Fixed Dose n = 34	Placebo n = 82
Value	-1.25 (-1.14)	-1.26 (-1.14)	-0.67 (-0.62)	-0.61 (-0.60)	-0.45 (NA)

Population analysed: The population is FAS prior to rescue, using the LOCF values (see table 27 in CSR)

29 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline - 6 month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Higher Dose	2 of 92 (2.2%)	22 of 92 (23.9%)	Not reported
Lower Dose	1 of 90 (1.1%)	36 of 90 (40%)	Not reported
40 mg Fixed Dose	1 of 50 (2%)	20 of 50 (40%)	Not reported
20 mg Fixed Dose	1 of 40 (2.5%)	10 of 40 (25%)	Not reported
Placebo	2 of 87 (2.3%)	14 of 87 (16.1%)	Not reported
Glipizide	3 of 93 (3.2%)	35 of 93 (37.6%)	Not reported
Open Label	1 of 71 (1.4%)	9 of 71 (12.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Eva Johnsson study director

AstraZeneca R&D Mölndal

John Wilding, DM FRCP principal investigator

University Hospital Aintree

77 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1656 and Glipizide in people with Type II Diabetes Mellitus, run by AstraZeneca at 77 sites in 11 countries.

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 26 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in Germany, Hungary, Mexico, United Kingdom, Latvia and 6 more countries. 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 26 Nov 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?

HbA1c: Change From Baseline to 4 Month (time frame: Baseline to 4th Month). 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 NCT01020123.

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 26 Nov 2012; AzTrials last refreshed its copy on 7 Nov 2026.