Type 2 DiabetesPhase 2PiVOTNCT05833958

Polypill Versus Metformin in New Onset Type 2 Diabetes

A Phase 2 study testing GMRx-4 IR polypill - sitagliptin, dapagliflozin, metformin and Metformin in people with Type 2 Diabetes, run by George Medicines PTY Limited.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The goal of this clinical trial is to learn about the effect of the GMRx-4 IR polypill compared to metformin monotherapy on glycosylated haemoglobin (HbA1c) when used as first line therapy in adults with recently diagnosed Type 2 Diabetes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: GMRx-4 IR polypill - sitagliptin, dapagliflozin, metformin and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Sep 2024to Sep 2025
Phase: Phase 2
Are there results?: None posted in the registry

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

Aged ≥18 years;
Diagnosis of Type 2 Diabetes (T2D) within 24 months;
Drug naïve or using metformin monotherapy at ≤1g daily;
Body mass index between 18.5 and 45 kg/m2;
HbA1c ≥6.0% (metformin monotherapy) or ≥6.5% (drug naïve), and ≤12%;
eGFR ≥45 ml/min/1.73m2;
Signed informed consent; and
Willingness to take a pregnancy test prior to starting treatment (participants of childbearing potential).

Who cannot join

There is a definite contraindication to either metformin, SGLT2 inhibitors or Dipeptidyl-peptidase 4 (DPP4) inhibitors;
There is a definite indication for an SGLT2 inhibitor;
A known situation where medication might be altered for a significant length of time (e.g., planned surgery);
Moderate or severe anaemia (Hb< 100g/L women and <110g/L in men), haemolytic anaemia or known haemoglobinopathy (which may affect the accurate measurement of HbA1c);
Unlikely to complete the trial, adhere to the trial or complete study contacts, including at-home pathology tests, according to investigator judgement; or
Known or suspected pregnancy or breast-feeding;
Participants of childbearing potential (participants who are anatomically and physiologically capable of becoming pregnant), or have a partner of childbearing potential, not willing to use highly effective contraceptive for the 16-week duration of the trial, and who do not confirm a negative pregnancy test before starting the drug;
Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the Investigator, and in discussion with the Medical Monitor, would make the participant inappropriate for entry into this study.

About this study

Official title: Polypill Versus Metformin in New Onset Type 2 Diabetes: a Low Dose Triple Therapy Polypill Versus Metformin for Glycaemic Control in Newly Diagnosed Type 2 Diabetes

That the GMRx-4 IR polypill, compared to metformin, will improve glucose lowering in those with recently diagnosed Type 2 Diabetes.

Participants will be required to take either:

One capsule of the GMRx-4 IR polypill each morning and one 175mg metformin capsule each evening for 16 weeks.

Or One metformin 500mg capsule each morning and each evening for 16 weeks.

Participants will not know which of the two treatment regimens they will be taking. Participants will be provided with the necessary guidance information, equipment, online support and telephone/video calls from trained members of the study team to complete the study procedures at home although some support from a Healthcare Professional either at home or at a clinic will be offered if needed. The study will involve participants completing the following information and procedures and reporting electronically:

Medical History (conditions and treatments) Gender Age Ethnicity/Race Weight Height Blood Pressure Heart Rate Blood collection for measurement of HbA1c (average blood glucose levels over a period of time), fasting glucose, creatinine and estimated glomerular filtration rate (eGFR) for kidney function, cholesterol, pregnancy (if not measured in a urine sample) Urine pregnancy test in women of child-bearing potential Concomitant Medications taken Safety outcomes Tolerability to the study treatment Adherence with taking the study treatment The number of any unused study treatment capsules

Conditions: Type 2 Diabetes
Being tested: GMRx-4 IR polypill - sitagliptin, dapagliflozin, metformin, 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.

GMRx-4 IR polypill - sitagliptin, dapagliflozin, metforminDrug
As described previously
MetforminDrug
As described previously - Experimental Arm, 175mg at night
MetforminDrug
As described previously - Active Comparator Arm, 500mg in the morning and 500mg at night

Study groups in NCT05833958
Study group	Role	What they receive
GMRx-4 IR polypill in the morning and metformin Immediate Release (IR)175mg at night	Experimental	One GMRx-4 IR polypill capsule (metformin IR 175mg + dapagliflozin 2.5mg + sitagliptin 17.5mg) in the morning and one metformin IR 175mg capsule at night. Capsules are taken with, or just after, food, and swallowed whole with water. Capsules will be taken at, or as close as possible to, the same time of morning (GMRx-4 IR) and the same time of evening (metformin 175mg) each day for 16 weeks. Receives: Drug: GMRx-4 IR polypill - sitagliptin, dapagliflozin, metformin; Drug: Metformin
Metformin IR 500mg in the morning and at night	Active comparator	One metformin IR 500mg capsule in the morning and at night. Capsules are taken with, or just after, food, and swallowed whole with water. Capsules will be taken at, or as close as possible to, the same time of morning and the same time of evening each day for 16 weeks. Receives: Drug: Metformin

What is being measured

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

Change in glycosylated haemoglobin (HbA1c)
Change in glycosylated haemoglobin (HbA1c) from baseline to 16 weeks
Measured: 16 weeks

Secondary outcomes (7)

Change in fasting plasma glucose
Change in fasting plasma glucose from baseline to 16 weeks
Measured: 16 weeks
Change in cholesterol
Change in fasting total cholesterol, LDL-cholesterol and HDL-cholesterol from baseline to 16 weeks
Measured: 16 weeks
Change in triglycerides
Change in fasting triglycerides from baseline to 16 weeks
Measured: 16 weeks
Change in blood pressure
Change in systolic and diastolic blood pressure from baseline to 16 weeks
Measured: 16 weeks
Change in weight in kilograms
Change in weight from baseline to 16 weeks
Measured: 16 weeks
Medication adherence
Medication adherence throughout the trial. Adherence will be assessed by self-report surveys entered directly into the ePRO platform (eCRF).
Measured: 16 weeks
Medication tolerability
Medication tolerability throughout the trial (based on permanent drug cessation due to side effects and incidence of reported side effects). Tolerability will be assessed by recording of adverse effects into self-report surveys, and adverse events identified by the Investigator during study contacts, entered directly into the ePRO platform (eCRF).
Measured: 16 weeks

Timeline

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

Sep 2024Sep 2025

First posted27 Apr 2023
Study startSep 2024 (estimated)
Primary completionSep 2025 (estimated)
Study completionSep 2025 (estimated)

Why it stopped: The sponsor has determined that this study will be postponed due to changing business priorities.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05833958
Sponsor's protocol ID: GMRx-4 IR
Acronym: PiVOT
Status last verified: Aug 2024
First submitted: 31 Mar 2023
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: If the sponsor receives a request for study-level data listing, then such requests will be reviewed by a committee that is composed of sponsor representation and steering committee members.

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?

Official record

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Polypill Versus Metformin in New Onset Type 2 Diabetes: a Low Dose Triple Therapy Polypill Versus Metformin for Glycaemic Control in Newly Diagnosed Type 2 Diabetes
ClinicalTrials.gov ID: NCT05833958
Acronym / sponsor ID: PiVOT / GMRx-4 IR
Conditions: Type 2 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The sponsor has determined that this study will be postponed due to changing business priorities.
Enrolment: 0 participants (actual)
Lead sponsor: George Medicines PTY LimitedIndustry (pharma, biotech, devices)
Collaborators: Brandon Biocatalyst, The George Institute
Study start: Sep 2024 (estimated)
Primary completion: Sep 2025 (estimated)
Study completion: Sep 2025 (estimated)
First posted: 27 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

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

That the GMRx-4 IR polypill, compared to metformin, will improve glucose lowering in those with recently diagnosed Type 2 Diabetes.

Participants will be required to take either:

One capsule of the GMRx-4 IR polypill each morning and one 175mg metformin capsule each evening for 16 weeks.

Or One metformin 500mg capsule each morning and each evening for 16 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
GMRx-4 IR polypill in the morning and metformin Immediate Release (IR)175mg at night	Experimental	Drug: GMRx-4 IR polypill - sitagliptin, dapagliflozin, metformin, Drug: MetforminOne GMRx-4 IR polypill capsule (metformin IR 175mg + dapagliflozin 2.5mg + sitagliptin 17.5mg) in the morning and one metformin IR 175mg capsule at night. Capsules are taken with, or just after, food, and swallowed whole with water. Capsules will be taken at, or as close as possible to, the same time of morning (GMRx-4 IR) and the same time of evening (metformin 175mg) each day for 16 weeks.
Metformin IR 500mg in the morning and at night	Active comparator	Drug: MetforminOne metformin IR 500mg capsule in the morning and at night. Capsules are taken with, or just after, food, and swallowed whole with water. Capsules will be taken at, or as close as possible to, the same time of morning and the same time of evening each day for 16 weeks.

Who may qualify

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

Key inclusion criteria (8 listed)

Aged ≥18 years;
Diagnosis of Type 2 Diabetes (T2D) within 24 months;
Drug naïve or using metformin monotherapy at ≤1g daily;
Body mass index between 18.5 and 45 kg/m2;
HbA1c ≥6.0% (metformin monotherapy) or ≥6.5% (drug naïve), and ≤12%;

Key exclusion criteria (8 listed)

There is a definite contraindication to either metformin, SGLT2 inhibitors or Dipeptidyl-peptidase 4 (DPP4) inhibitors;
There is a definite indication for an SGLT2 inhibitor;
A known situation where medication might be altered for a significant length of time (e.g., planned surgery);
Moderate or severe anaemia (Hb< 100g/L women and <110g/L in men), haemolytic anaemia or known haemoglobinopathy (which may affect the accurate measurement of HbA1c);
Unlikely to complete the trial, adhere to the trial or complete study contacts, including at-home pathology tests, according to investigator judgement; or

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
GMRx-4 IR polypill - sitagliptin, dapagliflozin, metforminAs described previously	Drug	GMRx-4 IR polypill in the morning and metformin Immediate Release (IR)175mg at night
MetforminAs described previously - Experimental Arm, 175mg at night	Drug	GMRx-4 IR polypill in the morning and metformin Immediate Release (IR)175mg at night
MetforminAs described previously - Active Comparator Arm, 500mg in the morning and 500mg at night	Drug	Metformin IR 500mg in the morning and at night

Primary outcome

Change in glycosylated haemoglobin (HbA1c)
Time frame: 16 weeks
Change in glycosylated haemoglobin (HbA1c) from baseline to 16 weeks

7 secondary outcomes

Change in fasting plasma glucose
Time frame: 16 weeks
Change in cholesterol
Time frame: 16 weeks
Change in triglycerides
Time frame: 16 weeks
Change in blood pressure
Time frame: 16 weeks
Change in weight in kilograms
Time frame: 16 weeks
Medication adherence
Time frame: 16 weeks
Medication tolerability
Time frame: 16 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Individual participant dataSharing planned: No. If the sponsor receives a request for study-level data listing, then such requests will be reviewed by a committee that is composed of sponsor representation and steering committee members.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
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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
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GMRx-4 IR polypill - sitagliptin, dapagliflozin, metformin and Metformin in people with Type 2 Diabetes, run by George Medicines PTY Limited.

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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study was withdrawn before enrolling participants, so there are no results.

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 glycosylated haemoglobin (HbA1c) (time frame: 16 weeks). 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 NCT05833958.

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 19 Sep 2024.