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Metformin Therapy for Overweight Adolescents With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881828
Recruitment Status : Completed
First Posted : June 20, 2013
Results First Posted : December 19, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Description
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Brief Summary:
The objective of the proposed research is to evaluate the efficacy and safety of the use of metformin in addition to standard insulin therapy in overweight and obese children and adolescents, age 12-<20 years, with type 1 diabetes for at least 1 year. Secondary objectives are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is still being produced by the beta cells of the pancreas, and on vascular dysfunction. In addition, an ancillary study is planned to assess if metformin will improve tissue-specific insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Metformin (glucophage) Other: oral placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Metformin as Adjunct Therapy for Overweight Adolescents With Type 1 Diabetes
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Metformin
Metformin 2000 mg per day
 Drug: Metformin (glucophage)
The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
Placebo Comparator: Oral Placebo

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
 Other: oral placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c. [ Time Frame: 0-26 weeks ]
    Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months


Secondary Outcome Measures :
  1. Change in Total Daily Dose of Insulin (TDI) Per kg [ Time Frame: 0-26 weeks ]
  2. Change in Body Mass Index (BMI) [ Time Frame: 0-26 weeks ]
  3. Change in Waist Circumference [ Time Frame: 0-26 weeks ]
  4. Change in Body Composition [ Time Frame: 0-26 weeks ]
    Change in percent body fat

  5. Change in Serum Lipids [ Time Frame: 0-26 weeks ]
  6. Change in Blood Pressure [ Time Frame: 0-26 weeks ]

Other Outcome Measures:
  1. Change in Liver Enzymes and Serum Creatinine [ Time Frame: 0-26 weeks ]
  2. Frequency of Severe Hypoglycemia [ Time Frame: 26 weeks ]
  3. Frequency of Diabetic Ketoacidosis [ Time Frame: 26 weeks ]
  4. Frequency of Gastrointestinal Side-effects Including Stomach Discomfort, Diarrhea, Nausea/Vomiting, Indigestion, Flatulence. [ Time Frame: 26 weeks ]
  5. Frequency of Lactic Acidosis [ Time Frame: 26 weeks ]
  6. Change in Adipocytokines [ Time Frame: 0-26 weeks ]
  7. Change in Androgen Levels in Females [ Time Frame: 0-26 weeks ]
  8. Change in C-peptide [ Time Frame: 0-26-weeks ]
    Measured with mixed meal tolerance test among participants with evidence of residual C-peptide on a non-fasting C-peptide at screening

  9. Change in Vascular Dysfunction [ Time Frame: 0-26 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. Age: 12 to <20 years.
  3. Duration of type 1 diabetes: ≥1 years.
  4. 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).
  5. Hemoglobin A1c: 7.5% - <10.0% from point of care measurement or local lab on day of screening visit or within 1 month prior.
  6. BMI: ≥85th percentile adjusted for age and sex .
  7. Total daily dose of insulin: ≥0.8 units per kg per day.
  8. 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.
  9. 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.
  10. Expected to comply with protocol in investigator's judgment.

Exclusion Criteria:

  1. 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).
  2. 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.
  3. 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.
  4. Any condition that in the judgment of the investigator will adversely affect the completion of the protocol.

  5. 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)
  6. Clinical diagnosis of celiac disease that is in poor control as defined by most recent tissue transglutaminase (tTG) that is in the abnormal range.
  7. History of ≥1 diabetic ketoacidosis events in the past 3 months.
  8. History of ≥1 severe hypoglycemic events (cognitive impairment that required assistance to treat) in the past 3 months.
  9. History of anemia or vitamin B12 deficiency in the past 2 years.
  10. Participation in an intervention study in the past 3 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881828


Locations
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United States, Florida
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
Sponsors and Collaborators
Jaeb Center for Health Research
Juvenile Diabetes Research Foundation
Investigators
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Principal Investigator: Kellee Miller, MPH Jaeb Center for Health Research
Study Chair: Ingrid Libman, MD, PhD Childrens Hospital of University of Pittsburgh Medical Center
Study Chair: Kristen Nadeau, MD University of Colorado Denver/Childrens Hospital Colorado
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01881828    
Other Study ID Numbers: T1DX-17-2013-506
17-2013-506 ( Other Grant/Funding Number: JDRF )
First Posted: June 20, 2013    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: March 3, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs