A Phase 4 interventional study of Lifestyle Intervention and Metformin in Diabetes, sponsored by Yale University. Terminated at 4 sites in 4 countries. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Yale University · Phase 4, Interventional, and Prevention
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Among 113 studies testing metformin in Diabetes Mellitus — 7 open to participants now, 7 under way, 1 of them phase 3. Metformin · Diabetes Mellitus.
Among the 113 studies testing metformin in Diabetes Mellitus, this one is the 55th largest by enrollment of the 112 interventional ones that give a count, is one of 4 that started in 2018, is one of 37 in phase 4, and was the 92nd registered.
8,291 studies on the registry are indexed under Diabetes Mellitus; 1,075 are open to participants now.
Browse Diabetes Mellitus studies →7 of the 113 studies testing metformin in Diabetes Mellitus are open now, in 6 countries. Recruiting first, the newest first:
Washington University School of Medicine · Sites in Nigeria
Ages 18+
Nabiqasim Industries (Pvt) Ltd · Sites in Pakistan
Ages 18–80
Boryung Pharmaceutical Co., Ltd · Sites in Korea, Republic of
Ages 19+ · Healthy volunteers
Boryung Pharmaceutical Co., Ltd · Sites in Korea, Republic of
Ages 19+ · Healthy volunteers
Ohio State University · Sites in United States
Ages 18+ · Women only
By country, each count listing its studies:
Metformin: first FDA approval 1995 (GLUCOPHAGE), first EMA approval 2003. What it is approved for, and how studies give it, is on its page →
Of the 649 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 40 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
113 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 17 · Phase 3 36 · Phase 4 37
First in 1996; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 114 is above the median of 80 across 6,024 interventional studies indexed under Diabetes Mellitus.
Median enrollment 108 across the 112 interventional studies. Of the 96 that completed or were terminated, 45 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
50 of 113 have an industry lead sponsor. The 10 most frequent:
Yale University is the lead sponsor of 1,771 studies on the registry; 295 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
26 studies in Diabetes Mellitus by Yale University: 3 open now, 3 under way, none of them phase 3. Of 21 finished, 8 (38%) have results posted.
Among the 26 studies in Diabetes Mellitus by Yale University, this one is the 8th largest by enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2018, is the only one in phase 4, and was the 17th registered.
Yale University’s Diabetes Mellitus studies by the year they started, since 2001.
None of the studies under way reaches primary completion within a year.
Among the 113 studies testing metformin in Diabetes Mellitus, from their registry updates:
Among Yale University’s 26 in Diabetes Mellitus:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes.
Hypothesis: This study seeks to test the hypothesis that implementation of a lifestyle intervention, with escalation to Metformin therapy will lower the incidence of diabetes among the highest risk pre-diabetic individuals of Caribbean-descent.
The investigators propose to conduct a pragmatic trial that tests the effectiveness of lifestyle modification and Metformin use in minority populations. Our study population is Caribbean-descent individuals in Region 2, Trinidad and Barbados. The investigators will have five clinical intervention sites situated in New York - 2, Puerto Rico -1, Barbados -1, Trinidad -1 and US Virgin Islands -1. These sites were chosen because of the investigators' strong research network in these locations, and to enable us to address diabetes disparities due to geographic differences. The investigators will first modify an established lifestyle modification workshop series developed by the East Harlem Partnership for Diabetes Prevention (EHPDP) for use in the community, 10to target the population at the involved clinical sites. The investigators plan to adapt the D-CLIP protocol and escalate to Metformin therapy for the highest risk pre-diabetic patients whose hemoglobin A1c (HbA1c) has not improved or who remain morbidly obese.
The investigators will leverage our existing robust research infrastructure and network at the five sites through our Eastern Caribbean Health Outcomes Research Network (ECHORN) and now the Yale Transdisciplinary Collaborative center for Health Disparities focused on Precision Medicine (Yale-TCC). ECHORN is a research collaboration funded by the NIMHD (U2458849938) to address the burden of chronic disease in USVI, PR and the Eastern Caribbean. The Yale-TCC (U54MD010711) leverages the infrastructure and knowledge of the ECHORN, expands to include New York and New Jersey and focuses on diabetes and hypertension. The investigators' network includes community advisory boards as well as policy delegations that are well suited to inform this project and its expansion into routine healthcare practice and policy.
The control arm of this study was never activated due to COVID-19 restrictions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Highest risk pre-diabetic patients
Behavioral: Lifestyle Intervention · Drug: Metformin
Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited. ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups.
The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control. The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.
At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.
Also known as: Glucophage
Change in Hemoglobin A1c (HbA1c)
Hemoglobin A1C (HbA1C) test was assessed via clinical tests.
Time frame: Baseline and 12 months
Change in Weight (kg)
Weight in kilograms (kg) assessed via clinical tests.
Time frame: Baseline and 6 months
Change in Systolic Blood Pressure
Systolic blood pressure assessed via clinical tests.
Time frame: Baseline and 6 months
Change in Diastolic Blood Pressure
Diastolic blood pressure assessed via clinical tests.
Time frame: Baseline and 6 months
Diabetes Risk Score
The Diabetes Risk Score has been designed to be a screening tool for identifying high-risk subjects in the population and for increasing awareness of the modifiable risk factors and healthy lifestyle. The score ranges from 0-20, with a higher score indicating higher risk.
Time frame: 6 months
Change in Self-Efficacy Score - Personal Control Scale
The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.
Time frame: Baseline and 6 months
Change in Self-Efficacy Score - Worry Scale
The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.
Time frame: 6 months
Change in Physical Activity Level.
Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire
Time frame: Baseline and 6 months
Change in Fruit and Vegetable Intake (Total Servings)
Total mean servings per day of fruit and vegetables self report via electronic survey.
Time frame: Baseline and 6 months
Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)
Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey.
Time frame: Baseline and 6 months
A total of 211 participants agreed to be a part of the study, 114 participants attended at least 1 workshop and are those considered "enrolled".
| Milestone | Intervention |
|---|---|
| Started | 114 |
| 6 month follow up | 80 |
| 12 month follow up | 52 |
| Completed | 52 |
| Not completed | 62 |
| Withdrew: Covid interruption of study | 54 |
| Withdrew: Lost to follow-up | 8 |
Hemoglobin A1C (HbA1C) test was assessed via clinical tests.
| percentage | Intervention |
|---|---|
| Baseline | 6.19 ± 0.15 |
| 12 Months | 5.67 ± 0.50 |
Weight in kilograms (kg) assessed via clinical tests.
| kg | Intervention |
|---|---|
| Baseline | 86.66 ± 16.63 |
| 6 Months | 85.00 ± 16.86 |
Systolic blood pressure assessed via clinical tests.
| mmHg | Intervention |
|---|---|
| Baseline | 133.93 ± 20.72 |
| 6 Months | 131.64 ± 18.54 |
Diastolic blood pressure assessed via clinical tests.
| mmHg | Intervention |
|---|---|
| Baseline | 84.86 ± 11.87 |
| 6 Months | 82.54 ± 10.49 |
The Diabetes Risk Score has been designed to be a screening tool for identifying high-risk subjects in the population and for increasing awareness of the modifiable risk factors and healthy lifestyle. The score ranges from 0-20, with a higher score indicating higher risk.
No measurements were reported for this outcome.
The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.
| units on a scale | Intervention |
|---|---|
| Baseline | 3.55 ± 0.50 |
| 6 Months | 3.64 ± 0.43 |
The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.
| units on a scale | Intervention |
|---|---|
| Baseline | 2.88 ± 1.01 |
| 6 Months | 2.83 ± 0.94 |
Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire
| Participants | Intervention |
|---|---|
| Baseline — Low | 22 |
| Baseline — Moderate | 22 |
| Baseline — High | 26 |
| 6 Months — Low | 28 |
| 6 Months — Moderate | 18 |
| 6 Months — High | 24 |
Total mean servings per day of fruit and vegetables self report via electronic survey.
| daily servings | Intervention |
|---|---|
| Baseline | 1.53 ± 0.97 |
| 6 Months | 1.61 ± 1.02 |
Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey.
| teaspoons | Intervention |
|---|---|
| Baseline | 7.30 ± 8.08 |
| 6 Months | 3.83 ± 4.10 |
Collected over Up to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/114 (0%) | 0/114 (0%) | 0/114 (0%) |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 51.3 ± 5.7 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 83 |
| Male | 31 |
| Race/Ethnicity, Customized(Participants) | Intervention |
|---|---|
| Race/Ethnicity — White | 1 |
| Race/Ethnicity — Black or African or Caribbean | 67 |
| Race/Ethnicity — Asian | 26 |
| Race/Ethnicity — Hispanic or Latino or Puerto Rican | 1 |
| Race/Ethnicity — Mixed or multi-racial | 18 |
| Race/Ethnicity — Unknown/Missing | 1 |
| Region of Enrollment(participants) | Intervention |
|---|---|
| United States | 114 |
| Education(Participants) | Intervention |
|---|---|
| Less than high school | 14 |
| High school | 45 |
| Some college | 28 |
| College or more | 26 |
| HbA1c(percentage) | Intervention |
|---|---|
| Mean | 6.2 ± 0.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Dec 2021, 40 months.
Results were first posted in Dec 2022, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin