Type 2 Diabetes MellitusPhase 1NCT02367066

A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)

A Phase 1 study testing AR-C165395XX in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United States.

Completed

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

Official record

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Trial summary

A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: AR-C165395XX
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Mar 2015to May 2015
Phase: Phase 1
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 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent
Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.
Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1)
ody mass index >19 to <38 kg/m2
he fasting plasma glucose should be in the range of 3-14 mmol/L (54-252 mg/dL, nclusive) on the morning of Visit 1.
Clinical diagnosis of type 2 diabetes mellitus
Metformin as only anti-diabetic treatment, at least for the last 3 months

Who cannot join

History or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results >3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
Patients treated with single Insulin therapy within the last 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Chula Vista, California

Other trials in United States

About this study

Official title: A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX After Administration of Repeated Doses for 3 Days in Subjects With Type 2 Diabetes Mellitus

A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

Read the detailed description

A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: AR-C165395XX, Placebo
Keywords: patients, glycaemic control on metformin
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.

AR-C165395XXDrug
Oral dose of AR-C165395XX (tablets)
PlaceboOther
Oral dose of placebo for AR-C165395XX (tablets)

Study groups in NCT02367066
Study group	Role	What they receive
AR-C165395XX + placebo	Experimental	1st period AR-C165395XX 2nd period placebo Receives: Drug: AR-C165395XX
Placebo + AR-C165395XX	Placebo comparator	1st period Placebo for AR-C165395XX 2nd period AR-C165395XX Receives: Other: Placebo

What is being measured

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

Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose
MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint MMTT C_max for Plasma Glucose
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide
GGI=Glucose and GLP1 infusion AUC=Area Under Curve
Measured: Day -1 to Day 3 and Day 6 to Day 9

Secondary outcomes (24)

Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint Fasting Beta-cell Responsiveness
Measured: Day -1 to Day 3 and Day 6 to Day 9
Fasting Insulin at Endpoint
Measured: Day 3 and Day 9
Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max
Measured: Days 2,3,8,9
Time of Maximum Plasma AZD1081 Concentration, t_ss,Max
Measured: Days 2,3,8,9
Plasma AZD1981 AUC(0-1h)
Measured: Days 2,3,8,9
Plasma AZD1981 AUC(0-2h)
Measured: Days 2,3,8,9
Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min
Measured: Days 2,3,8,9
Plasma AZD1981 AUC(1-2h)
Measured: Days 2,3,8,9
Plasma Paracetamol Maximum Concentration, C_max
Measured: Days 3,9
Time of Maximum Plasma Paracetamol Concentration, t_max
Measured: Days 3,9
Plasma Paracetamol AUC(0-t)
Measured: Days 3,9
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide
Measured: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose
Measured: Day -1 to Day 3 and Day 6 to Day 9
Plasma AZD1981 AUC(0-4h)
Measured: Days 2,3,8,9
Plasma AZD1981 AUC(0-12h)
Measured: Days 2,3,8,9
Plasma AZD1981 AUC(0-24h)
Measured: Days 2,3,8,9
Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F
Measured: Days 2,3,8,9

Timeline

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

Mar 2015May 2015

First posted20 Feb 2015 (estimated)
Study startMar 2015
Primary completionMay 2015
Study completionMay 2015

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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02367066
Sponsor's protocol ID: D6420C00001
Status last verified: May 2016
First submitted: 13 Feb 2015
Last updated: 23 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Skrtic S, Tyrberg B, Broberg M, Ericsson H, Schnecke V, Kjaer M, Hompesch M, Andersson EM, Ryberg E, Aivazidis A, Wennberg Huldt C, Lofgren L, Morrow L, Parkinson J, Ryden-Bergsten T, Watkins E, Sorhede Winzell M. Exploring the insulin secretory properties of the PGD2-GPR44/DP2 axis in vitro and in a randomized phase-1 trial of type 2 diabetes patients. PLoS One. 2018 Dec 17;13(12):e0208998. doi: 10.1371/journal.pone.0208998. eCollection 2018.
PubMed 30557325

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?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX After Administration of Repeated Doses for 3 Days in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02367066
Acronym / sponsor ID: D6420C00001
Conditions: Type 2 Diabetes Mellitus
Keywords: patients, glycaemic control on metformin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 20 Feb 2015 (estimated)
Results: Posted 23 Jun 2016

Clinical summary

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

A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
AR-C165395XX + placebo	Experimental	Drug: AR-C165395XX1st period AR-C165395XX 2nd period placebo
Placebo + AR-C165395XX	Placebo comparator	Other: Placebo1st period Placebo for AR-C165395XX 2nd period AR-C165395XX

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Provision of informed consent
Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.
Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1)
ody mass index >19 to <38 kg/m2
he fasting plasma glucose should be in the range of 3-14 mmol/L (54-252 mg/dL, nclusive) on the morning of Visit 1.

Key exclusion criteria (4 listed)

History or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results >3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
Patients treated with single Insulin therapy within the last 3 months

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
AR-C165395XXOral dose of AR-C165395XX (tablets)	Drug	AR-C165395XX + placebo
PlaceboOral dose of placebo for AR-C165395XX (tablets)	Other	Placebo + AR-C165395XX

Primary outcome

Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose
Time frame: Day -1 to Day 3 and Day 6 to Day 9
MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve
Change From Baseline to Endpoint MMTT C_max for Plasma Glucose
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide
Time frame: Day -1 to Day 3 and Day 6 to Day 9
GGI=Glucose and GLP1 infusion AUC=Area Under Curve

24 secondary outcomes

Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint Fasting Beta-cell Responsiveness
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Fasting Insulin at Endpoint
Time frame: Day 3 and Day 9
Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max
Time frame: Days 2,3,8,9
Time of Maximum Plasma AZD1081 Concentration, t_ss,Max
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(0-1h)
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(0-2h)
Time frame: Days 2,3,8,9
Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(1-2h)
Time frame: Days 2,3,8,9
Plasma Paracetamol Maximum Concentration, C_max
Time frame: Days 3,9
Time of Maximum Plasma Paracetamol Concentration, t_max
Time frame: Days 3,9
Plasma Paracetamol AUC(0-t)
Time frame: Days 3,9
Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose
Time frame: Day -1 to Day 3 and Day 6 to Day 9
Plasma AZD1981 AUC(0-4h)
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(0-12h)
Time frame: Days 2,3,8,9
Plasma AZD1981 AUC(0-24h)
Time frame: Days 2,3,8,9
Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F
Time frame: Days 2,3,8,9

Results and safety

Results posted to the registry on 23 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD1981-Placebo	10	10
Placebo-AZD1981	10	10

Primary outcome: Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose

Time frame: Day -1 to Day 3 and Day 6 to Day 9. Geometric mean (Standard Deviation). Unit: h*nmol/L

Measure	AZD1981 n = 20	Placebo n = 20
Value	0.92 (1.14)	0.98 (1.09)

AZD1981 vs Placebo: Geometric LS Mean Ratio: 0.94 (80% CI 0.90 to 0.98), p = 0.02, Mixed Models Analysis

Population analysed: One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.

Primary outcome: Change From Baseline to Endpoint MMTT C_max for Plasma Glucose

Time frame: Day -1 to Day 3 and Day 6 to Day 9. Geometric mean (Standard Deviation). Unit: nmol/L

Measure	AZD1981 n = 20	Placebo n = 20
Value	0.93 (1.12)	0.97 (1.09)

AZD1981 vs Placebo: Geometric LS Mean Ratio: 0.96 (80% CI 0.92 to 0.99), p = 0.06, Mixed Models Analysis

Primary outcome: Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide

Time frame: Day -1 to Day 3 and Day 6 to Day 9. Geometric mean (Standard Deviation). Unit: h*pmol/L

Measure	AZD1981 n = 20	Placebo n = 20
Value	1.05 (1.17)	1.06 (1.20)

AZD1981 vs Placebo: Geometric LS Mean Ratio: 0.99 (80% CI 0.96 to 1.03), p = 0.41, Mixed Models Analysis

24 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD1981	0 of 20 (0%)	5 of 20 (25%)	Not reported
Placebo	0 of 20 (0%)	6 of 20 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30557325Skrtic S, Tyrberg B, Broberg M, Ericsson H, Schnecke V, Kjaer M, Hompesch M, Andersson EM, Ryberg E, Aivazidis A, Wennberg Huldt C, Lofgren L, Morrow L, Parkinson J, Ryden-Bergsten T, Watkins E, Sorhede Winzell M. Exploring the insulin secretory properties of the PGD2-GPR44/DP2 axis in vitro and in a randomized phase-1 trial of type 2 diabetes patients. PLoS One. 2018 Dec 17;13(12):e0208998. doi: 10.1371/journal.pone.0208998. eCollection 2018.

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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.

Liliana Uribe-Bruce, MD, MCI principal investigator

Profil Institute for Clinical Research, Inc.

Stanko Skrtic, MD, PhD study director

AstraZeneca R&D Mölndal

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AR-C165395XX in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United States.

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 7 inclusion and 4 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 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 23 Jun 2016). 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 From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose (time frame: Day -1 to Day 3 and Day 6 to Day 9). The study lists 3 primary outcomes in all. 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 NCT02367066, 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 23 Jun 2016.