Clinical trial NCT05833958: Polypill Versus Metformin in New Onset Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: George Medicines PTY Limited
Sponsor class: INDUSTRY
Collaborators: name: Brandon Biocatalyst
name: The George Institute
First posted: 2023-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. The main question it aims to answer is:

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. There is a definite contraindication to either metformin, SGLT2 inhibitors or Dipeptidyl-peptidase 4 (DPP4) inhibitors;
2. There is a definite indication for an SGLT2 inhibitor;
3. A known situation where medication might be altered for a significant length of time (e.g., planned surgery);
4. 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);
5. Unlikely to complete the trial, adhere to the trial or complete study contacts, including at-home pathology tests, according to investigator judgement; or
6. Known or suspected pregnancy or breast-feeding;
7. 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;
8. 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.

Primary outcomes:
measure: Change in glycosylated haemoglobin (HbA1c)
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in fasting plasma glucose
timeFrame: 16 weeks
measure: Change in cholesterol
timeFrame: 16 weeks
measure: Change in triglycerides
timeFrame: 16 weeks
measure: Change in blood pressure
timeFrame: 16 weeks
measure: Change in weight in kilograms
timeFrame: 16 weeks
measure: Medication adherence
timeFrame: 16 weeks
measure: Medication tolerability
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References: