Investigational Study of Delayed Release Metformin (DREAM-T2D Trial)

Phase 3

Waitlist Available

Research Sponsored by Anji Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 28 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests Metformin DR, a special form of metformin that releases slowly in the small intestine, in patients with Type 2 Diabetes and varying kidney function. The goal is to see if it can better control blood sugar with fewer side effects. The study involves a treatment period followed by an extension. Metformin is the recommended first-line oral glucose-lowering drug for type 2 diabetes, known for its safety, cost-effectiveness, and ability to reduce cardiovascular mortality.

Eligible Conditions

Type 2 Diabetes
Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HbA1c

Secondary study objectives

Change in HbA1c (Met DR vs. metformin IR)

HbA1c response (Metformin DR vs. metformin IR)

HbA1c response (Metformin DR vs. placebo)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Investigational Arm (Metformin DR plus metformin IR placebo)Experimental Treatment2 Interventions

Group A will receive 1800 mg Metformin DR qAM + placebo for 1500 mg metformin IR in divided doses (2×placebo for metformin IR 500 mg qAM and 1×placebo for metformin IR 500 mg qPM).

Group II: Active Control Arm (Metformin DR placebo plus metformin IR)Active Control2 Interventions

Group C will receive placebo for 1800 mg Metformin DR qAM + 1500 mg metformin IR in divided doses (2× metformin IR 500 mg qAM and 1× metformin IR 500 mg qPM).

Group III: Placebo Arm (Metformin DR placebo plus metformin IR placebo)Placebo Group2 Interventions

Group B will receive placebo for 1800 mg Metformin DR qAM + placebo for 1500 mg metformin IR in divided doses (2× placebo for metformin IR 500 mg qAM and 1×placebo for metformin IR 500 mg qPM).

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