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Biguanide

Metformin DR for Type 2 Diabetes (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
Oral contraceptives (female patients)
Antihypertensive agents including ACEi/ARB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 28 weeks
Awards & highlights

DREAM-T2D Trial Summary

This trial is testing whether Metformin DR, which is designed to release metformin slowly in the small intestine, can improve glycemic control in T2DM patients with different levels of renal function safely.

Eligible Conditions
  • Type 2 Diabetes

DREAM-T2D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women who take birth control pills.
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You are taking medications to treat high blood pressure, including ACE inhibitors or ARBs.
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You are taking medication to lower your cholesterol levels.
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You are taking medication for thyroid replacement.
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You are taking medication for depression.
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You are taking medication or supplements that affect your body weight, including those for weight loss.

DREAM-T2D Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c
Secondary outcome measures
Change in HbA1c (Met DR vs. metformin IR)
HbA1c response (Metformin DR vs. metformin IR)
HbA1c response (Metformin DR vs. placebo)

DREAM-T2D 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).

Find a Location

Who is running the clinical trial?

Anji PharmaLead Sponsor
2 Previous Clinical Trials
199 Total Patients Enrolled
Rebecca DonovanStudy DirectorClinical Program Lead - Anji Pharma
Dan Meyers, MDStudy ChairChief Medical Officer - Anji Pharma
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Metformin DR's usual purpose?

"Metformin DR is most commonly taken as a preventative measure for type 2 diabetes. However, it can also be used to treat other medical conditions like type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Are elderly patients being considered for this clinical trial?

"This trial allows anyone that meets the age requirements of 18 or older and 100 or younger to participate."

Answered by AI

Has Metformin DR undergone FDA approval?

"Metformin DR is a Phase 3 trial medication, meaning that while there is some data supporting its efficacy, there is also multiple rounds of data supporting safety. Our team rates it as a 3 on our 1-to-3 scale."

Answered by AI

Are research subjects still being enrolled in this experiment?

"This is an active clinical trial, as seen on the website clinicaltrials.gov. The original posting date was 5/18/2021, with the most recent update being 6/7/2022."

Answered by AI

Is the data on Metformin DR conclusive?

"As of now, there are 45 ongoing Phase 3 trials and 180 total live studies investigating Metformin DR. Most of these investigations taking place in Rockville, Maryland; although, 1952 different locations across the world are running clinical trials for Metformin DR."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New Jersey
Other
Arizona
How old are they?
65+
18 - 65
What site did they apply to?
Lenzmeier Family Medicine/CCT Research
Aventiv Research
Academic Medical Research Institute
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
1

Why did patients apply to this trial?

Drugs tried don't seem to control or correct A1C issue. Met forming doesn't seem to help my condition and I would like to know why?
PatientReceived no prior treatments
Ive tried to other drugs and that didnt help so im hoping that this won will help me.
PatientReceived 2+ prior treatments
I started treating T2DM about 4 months ago and I want to potentially be part of the latest trials. I am disabled so the compensation helps.
PatientReceived no prior treatments
Although my time in range average is OK I still have many highs and lows. I would like by blood sugar to be more even and stable if possible. I also like the idea of helping with research.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
~176 spots leftby Mar 2025