Metformin Therapy for Overweight Adolescents With Type 1 Diabetes
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of presumed autoimmune type 1 diabetes (T1D) as indicated by age of diagnosis <10 years or documented positive diabetes-related autoantibodies.
a. Note: For randomization, presence of at least one of the diabetes-related autoantibodies [Insulin autoantibodies (IAA) at diagnosis prior to initiation of insulin, Islet cell antibodies (ICA), Anti-GAD (GAD65), Anti-IA2 (IA2), Zinc Transporter 8 (ZnT8)] must be documented either from medical records or new laboratory measurement (IAA and ICA not measured by central lab) sent to central lab for participants who were ≥10 years old at diagnosis.
- Age: 12 to <20 years.
- Duration of type 1 diabetes: ≥1 years.
- Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections).
- Hemoglobin A1c: 7.5% - <10.0% from point of care measurement or local lab on day of screening visit or within 1 month prior.
- BMI: ≥85th percentile adjusted for age and sex .
- Total daily dose of insulin: ≥0.8 units per kg per day.
- Average of ≥3 Self-Monitoring Blood Glucose (SMBG) tests per day prior to initiating study and from download of study-provided blood glucose meter following screening visit.
- Available for at least 6 months of follow-up, has home phone (or access to phone), and willing to be contacted by clinical site staff.
- Expected to comply with protocol in investigator's judgment.
Exclusion Criteria:
- Use of non-insulin medications for blood glucose control within prior 6 months or planning to use within next 6 months (other than study drug).
- Use of medications for weight reduction (such as: Belviq (lorcaserin), Qsymia (Phentermine + topiramate), Orlistat (xenical)) within the prior 6 months or planning to use within next 6 months.
- Use of a medication such as stimulants, psychotropic agents and oral/inhaled glucocorticoids that could affect weight gain or glycemic control of T1D or planning to use within the next 6 months.
- Any condition that in the judgment of the investigator will adversely affect the completion of the protocol.
Females: pregnant, lactating, or intending to become pregnant within the next 34 weeks
- A negative urine pregnancy test will be required for all females An effective contraceptive method or abstinence will be required for all females who have experienced menarche
- Requirements regarding pregnancy testing prior to enrollment and monitoring for pregnancy over the course of the study may be further defined by each individual Institutional Review Board (IRB)
- Clinical diagnosis of celiac disease that is in poor control as defined by most recent tissue transglutaminase (tTG) that is in the abnormal range.
- History of ≥1 diabetic ketoacidosis events in the past 3 months.
- History of ≥1 severe hypoglycemic events (cognitive impairment that required assistance to treat) in the past 3 months.
- History of anemia or vitamin B12 deficiency in the past 2 years.
- Participation in an intervention study in the past 3 months.
Sites / Locations
- Jaeb Center for Health Research
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Metformin
Oral Placebo
Metformin 2000 mg per day
A central pharmacy will compound a placebo to match the metformin tablets. The placebo product will contain the following components: Micosolle™, silica based excipient Silicified Micro Crystalline Cellulose, National Formulary Safflower Oil, United States Pharmacopeia K-30 Povidone Powder Magnesium Stearate, National Formulary (Vegetable source) Fumed Silica, National Formulary