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Metformin for Type 1 Diabetes and Obesity

Phase 2
Recruiting
Research Sponsored by Heba M. Ismail
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese youth 11-18 years of age with T1D at time of enrollment.
Be younger than 65 years old
Must not have
Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing).
History of chronic gastrointestinal disease, possible or confirmed celiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3, and month 6
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the role of the gut microbiome in type 1 diabetes in obese youth, and whether modifying the microbiome can help manage the disease.

Who is the study for?
This trial is for obese and lean youths aged 11-18 with Type 1 Diabetes (T1D). They should not have participated in other research trials within the last 3 months, had infections or antibiotic treatments in the past month, used metformin, or have chronic gastrointestinal diseases including celiac disease. Those with monogenic diabetes forms or immune-compromise conditions are also excluded.
What is being tested?
The study investigates how obesity affects young people with T1D by looking at their gut bacteria. It's testing whether Metformin, a common Type 2 diabetes medication, can help manage T1D in obese youth by altering their gut microbiome.
What are the potential side effects?
While this summary doesn't specify side effects of Metformin for this trial, generally it may cause digestive issues like stomach pain and diarrhea, taste changes, vitamin B12 deficiency over time, and rarely a serious condition called lactic acidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 11-18 years old, obese, and have Type 1 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a genetic form of diabetes or Type 2 diabetes confirmed by tests.
Select...
I have a long-term gut problem or celiac disease.
Select...
I have taken metformin for type 2 diabetes.
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I have not used steroids or immunosuppressants in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, and month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in the gut microbial metabolites in obese youth with type 1 in response to metformin
Changes in the gut microbiome in obese youth with type 1 diabetes in response to metformin
Differences in the gut microbial metabolites in lean and obese youth with type 1 diabetes
+1 more
Secondary study objectives
Changes in measures of C-peptide as a measure of beta cell health in obese T1D youth in response to metformin
Changes in measures of beta cell function using a timed mixed meal tolerance test
Changes in measures of insulin sensitivity in obese T1D youth in response to metformin
+4 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MetforminExperimental Treatment1 Intervention
This is a group of 30 youth with type 1 diabetes and obesity who will receive metformin for 6 months.
Group II: Comparison of microbiome by BMI CategoryActive Control1 Intervention
The gut microbiome and metabolites of 42 lean and 42 obese youth with type 1 diabetes will be evaluated cross-sectionally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,443 Previous Clinical Trials
4,331,013 Total Patients Enrolled
Heba M. IsmailLead Sponsor

Media Library

Metformin Clinical Trial Eligibility Overview. Trial Name: NCT05414409 — Phase 2
Type 1 Diabetes Research Study Groups: Metformin, Comparison of microbiome by BMI Category
Type 1 Diabetes Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT05414409 — Phase 2
Metformin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05414409 — Phase 2
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT05414409 — Phase 2
~50 spots leftby Aug 2026
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