Metformin Therapy for Overweight Adolescents With Type 1 Diabetes
NCT ID: NCT01881828
Last Updated: 2020-03-03
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
164 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-09-30
Study Completion Date
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance
NCT00667498
Pediatric Obesity
Insulin Resistance
Hyperinsulinemia
COMPLETED
PHASE4
Metformin Therapy in Type 1 Diabetes Mellitus.
NCT01889706
Loss of Control of Diabetes
UNKNOWN
MiTy Kids (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial)
NCT01832181
Type 2 Diabetes
COMPLETED
Metformin in Obese Children and Adolescents
NCT01487993
Obesity
Insulin Resistance
COMPLETED
PHASE3
The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM
NCT02765347
Diabetes Mellitus, Type 1
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Type 1 Diabetes
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Metformin
Metformin 2000 mg per day
Group Type
EXPERIMENTAL
Metformin (glucophage)
Intervention Type
DRUG
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.
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
Group Type
PLACEBO_COMPARATOR
oral placebo
Intervention Type
OTHER
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Intervention Type
DRUG
oral placebo
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
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.
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.
Minimum Eligible Age
12 Years
Maximum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Juvenile Diabetes Research Foundation
OTHER
Sponsor Role
collaborator
Jaeb Center for Health Research
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kellee Miller, MPH
Role: PRINCIPAL_INVESTIGATOR
Jaeb Center for Health Research
Ingrid Libman, MD, PhD
Role: STUDY_CHAIR
Childrens Hospital of University of Pittsburgh Medical Center
Kristen Nadeau, MD
Role: STUDY_CHAIR
University of Colorado Denver/Childrens Hospital Colorado
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jaeb Center for Health Research
Tampa, Florida, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Libman IM, Pietropaolo M, Arslanian SA, LaPorte RE, Becker DJ. Changing prevalence of overweight children and adolescents at onset of insulin-treated diabetes. Diabetes Care. 2003 Oct;26(10):2871-5. doi: 10.2337/diacare.26.10.2871.
Reference Type
BACKGROUND
Kaminski BM, Klingensmith GJ, Beck RW, Tamborlane WV, Lee J, Hassan K, Schatz D, Kollman C, Redondo MJ; Pediatric Diabetes Consortium. Body mass index at the time of diagnosis of autoimmune type 1 diabetes in children. J Pediatr. 2013 Apr;162(4):736-740.e1. doi: 10.1016/j.jpeds.2012.09.017. Epub 2012 Oct 23.
Reference Type
BACKGROUND
Liu LL, Lawrence JM, Davis C, Liese AD, Pettitt DJ, Pihoker C, Dabelea D, Hamman R, Waitzfelder B, Kahn HS; SEARCH for Diabetes in Youth Study Group. Prevalence of overweight and obesity in youth with diabetes in USA: the SEARCH for Diabetes in Youth study. Pediatr Diabetes. 2010 Feb;11(1):4-11. doi: 10.1111/j.1399-5448.2009.00519.x. Epub 2009 May 15.
Reference Type
BACKGROUND
Valerio G, Iafusco D, Zucchini S, Maffeis C; Study-Group on Diabetes of Italian Society of Pediatric Endocrinology and Diabetology (ISPED). Abdominal adiposity and cardiovascular risk factors in adolescents with type 1 diabetes. Diabetes Res Clin Pract. 2012 Jul;97(1):99-104. doi: 10.1016/j.diabres.2012.01.022. Epub 2012 Feb 13.
Reference Type
BACKGROUND
Purnell JQ, Hokanson JE, Marcovina SM, Steffes MW, Cleary PA, Brunzell JD. Effect of excessive weight gain with intensive therapy of type 1 diabetes on lipid levels and blood pressure: results from the DCCT. Diabetes Control and Complications Trial. JAMA. 1998 Jul 8;280(2):140-6. doi: 10.1001/jama.280.2.140.
Reference Type
BACKGROUND
Rodriguez BL, Dabelea D, Liese AD, Fujimoto W, Waitzfelder B, Liu L, Bell R, Talton J, Snively BM, Kershnar A, Urbina E, Daniels S, Imperatore G; SEARCH Study Group. Prevalence and correlates of elevated blood pressure in youth with diabetes mellitus: the SEARCH for diabetes in youth study. J Pediatr. 2010 Aug;157(2):245-251.e1. doi: 10.1016/j.jpeds.2010.02.021. Epub 2010 Apr 14.
Reference Type
BACKGROUND
Nadeau KJ, Regensteiner JG, Bauer TA, Brown MS, Dorosz JL, Hull A, Zeitler P, Draznin B, Reusch JE. Insulin resistance in adolescents with type 1 diabetes and its relationship to cardiovascular function. J Clin Endocrinol Metab. 2010 Feb;95(2):513-21. doi: 10.1210/jc.2009-1756. Epub 2009 Nov 13.
Reference Type
BACKGROUND
Snell-Bergeon JK, Hokanson JE, Jensen L, MacKenzie T, Kinney G, Dabelea D, Eckel RH, Ehrlich J, Garg S, Rewers M. Progression of coronary artery calcification in type 1 diabetes: the importance of glycemic control. Diabetes Care. 2003 Oct;26(10):2923-8. doi: 10.2337/diacare.26.10.2923.
Reference Type
BACKGROUND
Chait A, Bornfeldt KE. Diabetes and atherosclerosis: is there a role for hyperglycemia? J Lipid Res. 2009 Apr;50 Suppl(Suppl):S335-9. doi: 10.1194/jlr.R800059-JLR200. Epub 2008 Nov 23.
Reference Type
BACKGROUND
Maahs DM, Kinney GL, Wadwa P, Snell-Bergeon JK, Dabelea D, Hokanson J, Ehrlich J, Garg S, Eckel RH, Rewers MJ. Hypertension prevalence, awareness, treatment, and control in an adult type 1 diabetes population and a comparable general population. Diabetes Care. 2005 Feb;28(2):301-6. doi: 10.2337/diacare.28.2.301.
Reference Type
BACKGROUND
Wadwa RP, Kinney GL, Maahs DM, Snell-Bergeon J, Hokanson JE, Garg SK, Eckel RH, Rewers M. Awareness and treatment of dyslipidemia in young adults with type 1 diabetes. Diabetes Care. 2005 May;28(5):1051-6. doi: 10.2337/diacare.28.5.1051.
Reference Type
BACKGROUND
Borch-Johnsen K, Kreiner S. Proteinuria: value as predictor of cardiovascular mortality in insulin dependent diabetes mellitus. Br Med J (Clin Res Ed). 1987 Jun 27;294(6588):1651-4. doi: 10.1136/bmj.294.6588.1651.
Reference Type
BACKGROUND
Krolewski AS, Kosinski EJ, Warram JH, Leland OS, Busick EJ, Asmal AC, Rand LI, Christlieb AR, Bradley RF, Kahn CR. Magnitude and determinants of coronary artery disease in juvenile-onset, insulin-dependent diabetes mellitus. Am J Cardiol. 1987 Apr 1;59(8):750-5. doi: 10.1016/0002-9149(87)91086-1.
Reference Type
BACKGROUND
Snell-Bergeon JK, Hokanson JE, Kinney GL, Dabelea D, Ehrlich J, Eckel RH, Ogden L, Rewers M. Measurement of abdominal fat by CT compared to waist circumference and BMI in explaining the presence of coronary calcium. Int J Obes Relat Metab Disord. 2004 Dec;28(12):1594-9. doi: 10.1038/sj.ijo.0802796.
Reference Type
BACKGROUND
Maahs DM, Ogden LG, Kinney GL, Wadwa P, Snell-Bergeon JK, Dabelea D, Hokanson JE, Ehrlich J, Eckel RH, Rewers M. Low plasma adiponectin levels predict progression of coronary artery calcification. Circulation. 2005 Feb 15;111(6):747-53. doi: 10.1161/01.CIR.0000155251.03724.A5. Epub 2005 Feb 7.
Reference Type
BACKGROUND
Orchard TJ, Olson JC, Erbey JR, Williams K, Forrest KY, Smithline Kinder L, Ellis D, Becker DJ. Insulin resistance-related factors, but not glycemia, predict coronary artery disease in type 1 diabetes: 10-year follow-up data from the Pittsburgh Epidemiology of Diabetes Complications Study. Diabetes Care. 2003 May;26(5):1374-9. doi: 10.2337/diacare.26.5.1374.
Reference Type
BACKGROUND
Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.
Reference Type
BACKGROUND
Lloyd CE, Kuller LH, Ellis D, Becker DJ, Wing RR, Orchard TJ. Coronary artery disease in IDDM. Gender differences in risk factors but not risk. Arterioscler Thromb Vasc Biol. 1996 Jun;16(6):720-6. doi: 10.1161/01.atv.16.6.720.
Reference Type
BACKGROUND
Soedamah-Muthu SS, Chaturvedi N, Toeller M, Ferriss B, Reboldi P, Michel G, Manes C, Fuller JH; EURODIAB Prospective Complications Study Group. Risk factors for coronary heart disease in type 1 diabetic patients in Europe: the EURODIAB Prospective Complications Study. Diabetes Care. 2004 Feb;27(2):530-7. doi: 10.2337/diacare.27.2.530.
Reference Type
BACKGROUND
Amiel SA, Sherwin RS, Simonson DC, Lauritano AA, Tamborlane WV. Impaired insulin action in puberty. A contributing factor to poor glycemic control in adolescents with diabetes. N Engl J Med. 1986 Jul 24;315(4):215-9. doi: 10.1056/NEJM198607243150402.
Reference Type
BACKGROUND
Arslanian S, Heil BV, Kalhan SC. Hepatic insulin action in adolescents with insulin-dependent diabetes mellitus: relationship with long-term glycemic control. Metabolism. 1993 Mar;42(3):283-90. doi: 10.1016/0026-0495(93)90075-y.
Reference Type
BACKGROUND
Heptulla RA, Stewart A, Enocksson S, Rife F, Ma TY, Sherwin RS, Tamborlane WV, Caprio S. In situ evidence that peripheral insulin resistance in adolescents with poorly controlled type 1 diabetes is associated with impaired suppression of lipolysis: a microdialysis study. Pediatr Res. 2003 May;53(5):830-5. doi: 10.1203/01.PDR.0000059552.08913.B7.
Reference Type
BACKGROUND
Hiatt WR, Huang SY, Regensteiner JG, Micco AJ, Ishimoto G, Manco-Johnson M, Drose J, Reeves JT. Venous occlusion plethysmography reduces arterial diameter and flow velocity. J Appl Physiol (1985). 1989 May;66(5):2239-44. doi: 10.1152/jappl.1989.66.5.2239.
Reference Type
BACKGROUND
Regensteiner JG, Popylisen S, Bauer TA, Lindenfeld J, Gill E, Smith S, Oliver-Pickett CK, Reusch JE, Weil JV. Oral L-arginine and vitamins E and C improve endothelial function in women with type 2 diabetes. Vasc Med. 2003;8(3):169-75. doi: 10.1191/1358863x03vm489oa.
Reference Type
BACKGROUND
Urbina EM, Wadwa RP, Davis C, Snively BM, Dolan LM, Daniels SR, Hamman RF, Dabelea D. Prevalence of increased arterial stiffness in children with type 1 diabetes mellitus differs by measurement site and sex: the SEARCH for Diabetes in Youth Study. J Pediatr. 2010 May;156(5):731-7, 737.e1. doi: 10.1016/j.jpeds.2009.11.011. Epub 2010 Jan 25.
Reference Type
BACKGROUND
Wadwa RP, Urbina EM, Anderson AM, Hamman RF, Dolan LM, Rodriguez BL, Daniels SR, Dabelea D; SEARCH Study Group. Measures of arterial stiffness in youth with type 1 and type 2 diabetes: the SEARCH for diabetes in youth study. Diabetes Care. 2010 Apr;33(4):881-6. doi: 10.2337/dc09-0747. Epub 2010 Jan 12.
Reference Type
BACKGROUND
Haller MJ, Stein J, Shuster J, Theriaque D, Silverstein J, Schatz DA, Earing MG, Lerman A, Mahmud FH. Peripheral artery tonometry demonstrates altered endothelial function in children with type 1 diabetes. Pediatr Diabetes. 2007 Aug;8(4):193-8. doi: 10.1111/j.1399-5448.2007.00246.x.
Reference Type
BACKGROUND
Mortensen HB, Robertson KJ, Aanstoot HJ, Danne T, Holl RW, Hougaard P, Atchison JA, Chiarelli F, Daneman D, Dinesen B, Dorchy H, Garandeau P, Greene S, Hoey H, Kaprio EA, Kocova M, Martul P, Matsuura N, Schoenle EJ, Sovik O, Swift PG, Tsou RM, Vanelli M, Aman J. Insulin management and metabolic control of type 1 diabetes mellitus in childhood and adolescence in 18 countries. Hvidore Study Group on Childhood Diabetes. Diabet Med. 1998 Sep;15(9):752-9. doi: 10.1002/(SICI)1096-9136(199809)15:93.0.CO;2-W.
Reference Type
BACKGROUND
Hamilton J, Cummings E, Zdravkovic V, Finegood D, Daneman D. Metformin as an adjunct therapy in adolescents with type 1 diabetes and insulin resistance: a randomized controlled trial. Diabetes Care. 2003 Jan;26(1):138-43. doi: 10.2337/diacare.26.1.138.
Reference Type
BACKGROUND
Cusi D, Bianchi G. A primer on the genetics of hypertension. Kidney Int. 1998 Aug;54(2):328-42. doi: 10.1046/j.1523-1755.1998.00007.x. No abstract available.
Reference Type
BACKGROUND
Ibanez L, Lopez-Bermejo A, Diaz M, Marcos MV, de Zegher F. Early metformin therapy (age 8-12 years) in girls with precocious pubarche to reduce hirsutism, androgen excess, and oligomenorrhea in adolescence. J Clin Endocrinol Metab. 2011 Aug;96(8):E1262-7. doi: 10.1210/jc.2011-0555. Epub 2011 Jun 1.
Reference Type
BACKGROUND
Kendall D, Vail A, Amin R, Barrett T, Dimitri P, Ivison F, Kibirige M, Mathew V, Matyka K, McGovern A, Stirling H, Tetlow L, Wales J, Wright N, Clayton P, Hall C. Metformin in obese children and adolescents: the MOCA trial. J Clin Endocrinol Metab. 2013 Jan;98(1):322-9. doi: 10.1210/jc.2012-2710. Epub 2012 Nov 21.
Reference Type
BACKGROUND
Tarkun I, Dikmen E, Cetinarslan B, Canturk Z. Impact of treatment with metformin on adipokines in patients with polycystic ovary syndrome. Eur Cytokine Netw. 2010 Dec;21(4):272-7. doi: 10.1684/ecn.2010.0217. Epub 2010 Dec 3.
Reference Type
BACKGROUND
Steinberg HO, Baron AD. Vascular function, insulin resistance and fatty acids. Diabetologia. 2002 May;45(5):623-34. doi: 10.1007/s00125-002-0800-2. Epub 2002 Apr 4.
Reference Type
BACKGROUND
Regensteiner JG, Bauer TA, Reusch JE. Rosiglitazone improves exercise capacity in individuals with type 2 diabetes. Diabetes Care. 2005 Dec;28(12):2877-83. doi: 10.2337/diacare.28.12.2877.
Reference Type
BACKGROUND
Agarwal N, Rice SP, Bolusani H, Luzio SD, Dunseath G, Ludgate M, Rees DA. Metformin reduces arterial stiffness and improves endothelial function in young women with polycystic ovary syndrome: a randomized, placebo-controlled, crossover trial. J Clin Endocrinol Metab. 2010 Feb;95(2):722-30. doi: 10.1210/jc.2009-1985. Epub 2009 Dec 8.
Reference Type
BACKGROUND
Montanari G, Bondioli A, Rizzato G, Puttini M, Tremoli E, Mussoni L, Mannucci L, Pazzucconi F, Sirtori CR. Treatment with low dose metformin in patients with peripheral vascular disease. Pharmacol Res. 1992 Jan;25(1):63-73. doi: 10.1016/s1043-6618(05)80065-9.
Reference Type
BACKGROUND
Pitocco D, Zaccardi F, Tarzia P, Milo M, Scavone G, Rizzo P, Pagliaccia F, Nerla R, Di Franco A, Manto A, Rocca B, Lanza GA, Crea F, Ghirlanda G. Metformin improves endothelial function in type 1 diabetic subjects: a pilot, placebo-controlled randomized study. Diabetes Obes Metab. 2013 May;15(5):427-31. doi: 10.1111/dom.12041. Epub 2012 Dec 5.
Reference Type
BACKGROUND
Bailey CJ. Metformin: a multitasking medication. Diab Vasc Dis Res. 2008 Sep;5(3):156. doi: 10.3132/dvdr.2008.026. No abstract available.
Reference Type
BACKGROUND
Liebson PR. Diabetes control and cardiovascular risk, Part II: Intensive glucose control--UKPDS follow-up. Prev Cardiol. 2009 Winter;12(1):51-8. doi: 10.1111/j.1751-7141.2008.00020.x. No abstract available.
Reference Type
BACKGROUND
Vella S, Buetow L, Royle P, Livingstone S, Colhoun HM, Petrie JR. The use of metformin in type 1 diabetes: a systematic review of efficacy. Diabetologia. 2010 May;53(5):809-20. doi: 10.1007/s00125-009-1636-9. Epub 2010 Jan 8.
Reference Type
BACKGROUND
Sarnblad S, Kroon M, Aman J. Metformin as additional therapy in adolescents with poorly controlled type 1 diabetes: randomised placebo-controlled trial with aspects on insulin sensitivity. Eur J Endocrinol. 2003 Oct;149(4):323-9. doi: 10.1530/eje.0.1490323.
Reference Type
BACKGROUND
TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.
Reference Type
BACKGROUND
Reinstatler L, Qi YP, Williamson RS, Garn JV, Oakley GP Jr. Association of biochemical B(1)(2) deficiency with metformin therapy and vitamin B(1)(2) supplements: the National Health and Nutrition Examination Survey, 1999-2006. Diabetes Care. 2012 Feb;35(2):327-33. doi: 10.2337/dc11-1582. Epub 2011 Dec 16.
Reference Type
BACKGROUND
Nadeau KJ, Ehlers LB, Zeitler PS, Love-Osborne K. Treatment of non-alcoholic fatty liver disease with metformin versus lifestyle intervention in insulin-resistant adolescents. Pediatr Diabetes. 2009 Feb;10(1):5-13. doi: 10.1111/j.1399-5448.2008.00450.x. Epub 2008 Aug 20.
Reference Type
BACKGROUND
Salpeter SR, Greyber E, Pasternak GA, Salpeter EE. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD002967. doi: 10.1002/14651858.CD002967.pub4.
Reference Type
BACKGROUND
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.
Reference Type
BACKGROUND
Dabelea D, D'Agostino RB Jr, Mason CC, West N, Hamman RF, Mayer-Davis EJ, Maahs D, Klingensmith G, Knowler WC, Nadeau K. Development, validation and use of an insulin sensitivity score in youths with diabetes: the SEARCH for Diabetes in Youth study. Diabetologia. 2011 Jan;54(1):78-86. doi: 10.1007/s00125-010-1911-9. Epub 2010 Oct 1.
Reference Type
BACKGROUND
Libman IM, Miller KM, DiMeglio LA, Bethin KE, Katz ML, Shah A, Simmons JH, Haller MJ, Raman S, Tamborlane WV, Coffey JK, Saenz AM, Beck RW, Nadeau KJ; T1D Exchange Clinic Network Metformin RCT Study Group. Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2015 Dec 1;314(21):2241-50. doi: 10.1001/jama.2015.16174.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-2013-506
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
T1DX-17-2013-506
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Metformin & Inflammation in Pre-diabetic Children
NCT01394887
COMPLETED
PHASE2/PHASE3
Adjunctive Metformin Therapy in Double Diabetes
NCT01334125
COMPLETED
PHASE3
Glaser Obesity Study
NCT00209482
UNKNOWN
PHASE2/PHASE3
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
NCT01541215
COMPLETED
PHASE3
Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children
NCT02063802
UNKNOWN
PHASE2
Study of Efficacy of Metformin in the Treatment of Acanthosis Nigricans in Children With Obesity
NCT02438020
UNKNOWN
PHASE4
A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin
NCT00231660
COMPLETED
PHASE3
Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
NCT00970593
COMPLETED
PHASE1
A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.
NCT00035542
COMPLETED
PHASE3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
NCT04578652
RECRUITING
PHASE3
Precision Dosing of Metformin in Youth With T2D
NCT06120881
RECRUITING
EARLY_PHASE1
Metformin in Overweight Type 2 Diabetes Mellitus
NCT00922194
COMPLETED
NA
The Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial
NCT05025852
RECRUITING
Late Metabolic Effects of Metformin Therapy in Gestational Diabetes
NCT02417090
COMPLETED
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects
NCT00944177
COMPLETED
PHASE1
Extension Study for 2993-112
NCT01789957
COMPLETED
PHASE3
Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
NCT00353691
COMPLETED
PHASE3
Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
NCT00118950
COMPLETED
PHASE4
Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo
NCT05949008
ACTIVE_NOT_RECRUITING
PHASE4
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.
NCT01089205
COMPLETED
PHASE1
A Study of the Safety and Efficacy of Omarigliptin (MK-3102) in ≥18 and <45 Year-Old Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028)
NCT01814748
COMPLETED
PHASE3
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects
NCT00944346
COMPLETED
PHASE1
Oral Metformin for Treating Melasma in Latin American Women
NCT06845540
RECRUITING
PHASE1/PHASE2
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fasting Conditions.
NCT01089192
COMPLETED
PHASE1
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
NCT00511667
COMPLETED
PHASE1