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FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR) (FLAT-SUGAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01524705
First Posted: February 2, 2012
Last Update Posted: September 18, 2014
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.
Collaborators:
Eli Lilly and Company
Sanofi
Bristol-Myers-Squibb/Astra-Zeneca
DexCom, Inc.
Bayer
Becton, Dickinson and Company
Medicomp
University of Texas
VA Office of Research and Development
Biomedical Research Institute of New Mexico
Information provided by (Responsible Party):
Jeff Probstfield, University of Washington
  Purpose

Results of recent studies using standard long and short acting insulin therapy (Basal - Bolus or BBI) in type 2 diabetes mellitus (T2DM) have not shown benefits to lower risks for heart attacks, strokes, or eye, nerve and kidney problems. Some studies also show a long time between the start of treatment and signs of benefit. This has led to a review of current ways to normalize blood glucose control with basal bolus insulin and how to make blood glucose better. Improving blood sugar with insulin therapy usually causes weight gain, more high sugar levels after meals, and more low blood sugars. Early studies suggest that when people take long-acting insulin and metformin, they have fewer blood sugar extremes when they also take a new type of medicine called glucagon-like polypeptide-1 (GLP-1) agonist named exenatide (Byetta), instead of meal-time insulin. This means there might be a better way to treat Type 2 diabetes.

Participants are asked to take part in an eight month study to find out if middle-aged and older people with Type 2 diabetes who have added risk factors for heart disease can even out their blood sugar levels. They will start on long-acting insulin, mealtime insulin, and metformin, if they are not already on these medications. Their kidney function tests must be normal and they must not be allergic to metformin. Then, after a 2 month run-in phase, they must be willing to be assigned by chance into one of two groups. This means that they will have a 50/50 chance (like flipping a coin) of being in either group. Half of them will be started on the new medicine known as Byetta rather than the meal-time insulin and the other half will remain on the meal-time insulin during the next 6 months (26 weeks) to see which group has more steady blood sugars. They will be asked to use a continuous blood sugar monitoring system called DexCom. A sensor is inserted under the skin in the same areas the insulin is injected. The DexCom can check their blood sugars 24 hours of the day and night and will be worn until 7 days of recordings are collected. In the same 7 day period, they will also be asked to wear a Holter or Telemetry monitor that will record their heart beats and rhythm which will be compared to the blood sugar readings. They will also use home glucose meters to check their glucose levels about 3 to 4 times a day. The study will take place at 12 centers in the United States and enroll about 120-130 people.


Condition Intervention Phase
Type 2 Diabetes Drug: "GLIPULIN:" [insulin glargine, metformin, exenatide (GLP-1-agonist)] Drug: Insulin glargine, metformin, prandial insulin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FLAT-SUGAR: FLuctuATion Reduction With inSULin and Glp-1 Added togetheR

Resource links provided by NLM:


Further study details as provided by Jeff Probstfield, University of Washington:

Primary Outcome Measures:
  • The change in the coefficient of variation of continuous glucose readings, as assessed by CGM. [ Time Frame: At baseline, 3 and 6 mo of intervention ]

Secondary Outcome Measures:
  • The secondary trial goal will be to evaluate the frequency of hypoglycemia in the two interventional arms. [ Time Frame: 10 days, 4, 11, 13, 19, 24 and 26 wks ]

    Severe Hypoglycemia-documented glucose <50mg/dl (participant journal), and hypoglycemic attacks requiring hospitalization, or treatment by emergency personnel.

    Possible side effects to Metformin, Insulin(either short or long acting)and Exenatide



Enrollment: 102
Study Start Date: August 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin Glargine, metformin, exenatide
Approximately 60 Type 2 DM participants will be instructed on an AHA/ADA meal plan. Insulin Glargine, metformin and exenatide will used as a combination strategy to control individual HBA1Cs between 6.7 and 7.3% throughout the trial.
Drug: "GLIPULIN:" [insulin glargine, metformin, exenatide (GLP-1-agonist)]
Glargine-injectable, variable, QD, 6 months Metformin-oral, up to 1000mg, BID, 6 months Exenatide-injectable, 5mcg, BID, 6 months
Other Name: Glipulin is a short name that has been given to the combination of glargine, metformin and exenatide (a GLP1 agonist). Combination used previously.
Active Comparator: glargine, metformin, prandial insulin
Approximately 60 type 2 DM participants will be instructed in AHA/ADA meal plan. Insulin Glargine, metformin and one of 3 prandial insulins will be used as combination strategy to control individual HBA1Cs between 6.7 and 7.3%. Prandial Insulins (aspart, glulisine or lispro)
Drug: Insulin glargine, metformin, prandial insulin
Approximately 60 type 2 DM participants will be instructed in AHA/ADA meal plan. Insulin Glargine, metformin and one of 3 prandial insulins will be used as combination strategy to control individual HBA1Cs between 6.7 and 7.3%. Prandial Insulins (aspart, glulisine or lispro)
Other Names:
  • Insulin Glargine
  • Metformin
  • One Prandial Insulin (aspart or glulisine or lispro)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. T2DM for >12 months defined according to current ADA criteria
  2. C-peptide >0.5 ng/mL-after informed consent has been signed, samples will be drawn fasting and sent to a central lab
  3. Participants must be on insulin therapy. Diabetes, Blood Pressure & Lipid therapy must be stable (in both dose and agent) for ≥3 months (dose of any 1 drug has not changed by more than 2-fold, & new agents not been added within the previous 3 months)
  4. HbA1c 7.5-8.5% for enrollment
  5. Age at enrollment (screening): 40-75 years (inclusive) when there is a history of cardiovascular disease (defined in 'a'), or 55 to 75 years (inclusive) when there is not a history of cardiovascular disease but 2 or more risk factors (with or without treatment) are present (defined in 'b')

    a) Established cardiovascular disease defined as presence of one of the following: i. Previous myocardial infarction (MI). (most recent must be > 3 months prior enrollment) ii. Previous stroke. (most recent must be >3 months prior enrollment) iii. History of coronary revascularization (e.g., coronary artery bypass graft surgery, stent placement, percutaneous transluminal coronary angioplasty, or laser atherectomy)(most recent must be > 3 months prior enrollment) iv. History of carotid or peripheral revascularization (e.g., carotid endarterectomy, lower extremity atherosclerotic disease atherectomy, repair of abdominal aortic aneurysm, femoral or popliteal bypass). (most recent must be >3 months prior enrollment) v. Angina with either ischemic changes on a resting ECG, or ECG changes on a graded exercise test (GXT), or positive cardiac imaging study vi. Ankle/brachial index <0.9 vii. LVH with strain by ECG or ECHO viii. >50% stenosis of a coronary, carotid, renal or lower extremity artery. ix. Urine albumin to urine creatinine ratio of >30 mg albumin/g creatinine in 2 samples, separated by at least 7 days, within past 12 months) [Target of 50% of study cohort] or b) Increased CVD risk defined as presence of 2 or more of the following: i. Untreated LDL-C >130 mg/dL or on lipid treatment ii. Low HDL-C (<40 mg/dL for men and <50 mg/dL for women) iii. Untreated systolic BP >140 mm Hg, or on antihypertensive treatment iv. Current cigarette smoking v. Body mass index 25-45 (Asian populations 23-45) kg/m2

  6. No expectation that participant will move out of clinical center area during the next 8 months, unless move will be to an area served by another trial center
  7. Ability to speak & read English

Exclusion Criteria:

  1. The presence of a physical disability, significant medical or psychiatric disorder; substance abuse or use of a medication that in the judgment of the investigator will affect the use of CGM, wearing of the sensors, Holter or Telemetry monitor, complex medication regimen, or completion of any aspect of the protocol
  2. Cannot have had any cardiovascular event or interventional procedure, (MI, Stroke or revascularization) or been hospitalized for unstable angina within the last 3 months
  3. Inability or unwillingness to discontinue use of acetaminophen products during CGM use
  4. Inability or unwillingness to discontinue use of all other diabetes agents other than insulin & metformin during trial (including insulin pump participants who will need to convert to BBI)
  5. Intolerance of metformin dose <500 mg/day
  6. Inability or unwillingness to perform blood glucose testing a minimum of 3 times/per day
  7. Creatinine level ≥1.5 for males or 1.4 for females
  8. ALT level ≥ 3 times upper limit of normal
  9. Current symptomatic heart failure, history of NYHA Class III or IV congestive heart failure at any time, or ejection fraction (by any method) < 25%
  10. Inpatient psychiatric treatment in the past 6 months
  11. Currently participating in an intervention trial
  12. Chronic inflammatory diseases, such as collagen vascular diseases or inflammatory bowel disease
  13. History of pancreatitis
  14. BMI >45kg/m2
  15. For females, pregnant or intending to become pregnant during the next 7 months
  Contacts and Locations
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): NCT01524705


Locations
United States, California
So Calif. Permanente Medical Group
San Diego, California, United States, 92109
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Kaledia Health of Western New York
Buffalo, New York, United States, 14209
United States, North Carolina
Diabetes Care Center
Durham, North Carolina, United States, 27713
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Vermont
University of Vermont
Colchester, Vermont, United States, 05446
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Washington State University Spokane, College of Pharmacy Spokane WA 99202 USA
Spokane, Washington, United States, 99202
Sponsors and Collaborators
University of Washington
Eli Lilly and Company
Sanofi
Bristol-Myers-Squibb/Astra-Zeneca
DexCom, Inc.
Bayer
Becton, Dickinson and Company
Medicomp
University of Texas
VA Office of Research and Development
Biomedical Research Institute of New Mexico
Investigators
Principal Investigator: Jeffrey L Probstfield, MD Professor of Medicine, University of Washington
  More Information

Additional Information:
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ADVANCE Collaborative Group, Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6.
Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD; VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009 Jan 8;360(2):129-39. doi: 10.1056/NEJMoa0808431. Epub 2008 Dec 17. Erratum in: N Engl J Med. 2009 Sep 3;361(10):1028. N Engl J Med. 2009 Sep 3;361(10):1024-5.
Davì G, Ciabattoni G, Consoli A, Mezzetti A, Falco A, Santarone S, Pennese E, Vitacolonna E, Bucciarelli T, Costantini F, Capani F, Patrono C. In vivo formation of 8-iso-prostaglandin f2alpha and platelet activation in diabetes mellitus: effects of improved metabolic control and vitamin E supplementation. Circulation. 1999 Jan 19;99(2):224-9.
Tannock LR, O'Brien KD, Knopp RH, Retzlaff B, Fish B, Wener MH, Kahn SE, Chait A. Cholesterol feeding increases C-reactive protein and serum amyloid A levels in lean insulin-sensitive subjects. Circulation. 2005 Jun 14;111(23):3058-62. Epub 2005 Jun 6.
Festa A, D'Agostino R Jr, Howard G, Mykkänen L, Tracy RP, Haffner SM. Chronic subclinical inflammation as part of the insulin resistance syndrome: the Insulin Resistance Atherosclerosis Study (IRAS). Circulation. 2000 Jul 4;102(1):42-7.
Dandona P, Chaudhuri A, Ghanim H, Mohanty P. Insulin as an anti-inflammatory and antiatherogenic modulator. J Am Coll Cardiol. 2009 Feb 3;53(5 Suppl):S14-20. doi: 10.1016/j.jacc.2008.10.038. Review.
Dogné JM, Hanson J, Pratico D. Thromboxane, prostacyclin and isoprostanes: therapeutic targets in atherogenesis. Trends Pharmacol Sci. 2005 Dec;26(12):639-44. Epub 2005 Oct 21. Review.
Buscemi S, Verga S, Cottone S, Azzolina V, Buscemi B, Gioia D, Cerasola G. Glycaemic variability and inflammation in subjects with metabolic syndrome. Acta Diabetol. 2009 Mar;46(1):55-61. doi: 10.1007/s00592-008-0061-8. Epub 2008 Sep 26.
Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7.
Ceriello A, Esposito K, Piconi L, Ihnat MA, Thorpe JE, Testa R, Boemi M, Giugliano D. Oscillating glucose is more deleterious to endothelial function and oxidative stress than mean glucose in normal and type 2 diabetic patients. Diabetes. 2008 May;57(5):1349-54. doi: 10.2337/db08-0063. Epub 2008 Feb 25.
Esposito K, Ciotola M, Carleo D, Schisano B, Sardelli L, Di Tommaso D, Misso L, Saccomanno F, Ceriello A, Giugliano D. Post-meal glucose peaks at home associate with carotid intima-media thickness in type 2 diabetes. J Clin Endocrinol Metab. 2008 Apr;93(4):1345-50. doi: 10.1210/jc.2007-2000. Epub 2008 Jan 15.
Esposito K, Giugliano D, Nappo F, Marfella R; Campanian Postprandial Hyperglycemia Study Group. Regression of carotid atherosclerosis by control of postprandial hyperglycemia in type 2 diabetes mellitus. Circulation. 2004 Jul 13;110(2):214-9. Epub 2004 Jun 14.
Stehouwer CD, Gall MA, Twisk JW, Knudsen E, Emeis JJ, Parving HH. Increased urinary albumin excretion, endothelial dysfunction, and chronic low-grade inflammation in type 2 diabetes: progressive, interrelated, and independently associated with risk of death. Diabetes. 2002 Apr;51(4):1157-65.
Shikano M, Sobajima H, Yoshikawa H, Toba T, Kushimoto H, Katsumata H, Tomita M, Kawashima S. Usefulness of a highly sensitive urinary and serum IL-6 assay in patients with diabetic nephropathy. Nephron. 2000 May;85(1):81-5.
KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154.
Dinneen SF, Gerstein HC. The association of microalbuminuria and mortality in non-insulin-dependent diabetes mellitus. A systematic overview of the literature. Arch Intern Med. 1997 Jul 14;157(13):1413-8. Review.
Gerstein HC, Mann JF, Yi Q, Zinman B, Dinneen SF, Hoogwerf B, Hallé JP, Young J, Rashkow A, Joyce C, Nawaz S, Yusuf S; HOPE Study Investigators. Albuminuria and risk of cardiovascular events, death, and heart failure in diabetic and nondiabetic individuals. JAMA. 2001 Jul 25;286(4):421-6.
Ruggenenti P, Remuzzi G. Time to abandon microalbuminuria? Kidney Int. 2006 Oct;70(7):1214-22. Epub 2006 Jul 26. Review.
Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38.
Robinson RT, Harris ND, Ireland RH, Lee S, Newman C, Heller SR. Mechanisms of abnormal cardiac repolarization during insulin-induced hypoglycemia. Diabetes. 2003 Jun;52(6):1469-74.
Desouza C, Salazar H, Cheong B, Murgo J, Fonseca V. Association of hypoglycemia and cardiac ischemia: a study based on continuous monitoring. Diabetes Care. 2003 May;26(5):1485-9.
Gill GV, Woodward A, Casson IF, Weston PJ. Cardiac arrhythmia and nocturnal hypoglycaemia in type 1 diabetes--the 'dead in bed' syndrome revisited. Diabetologia. 2009 Jan;52(1):42-5. doi: 10.1007/s00125-008-1177-7. Epub 2008 Oct 30.
Dungan KM, Buse JB, Largay J, Kelly MM, Button EA, Kato S, Wittlin S. 1,5-anhydroglucitol and postprandial hyperglycemia as measured by continuous glucose monitoring system in moderately controlled patients with diabetes. Diabetes Care. 2006 Jun;29(6):1214-9.
Kadowaki T, Yamauchi T. Adiponectin and adiponectin receptors. Endocr Rev. 2005 May;26(3):439-51. Review.
Sun J, Xu Y, Deng H, Sun S, Dai Z, Sun Y. Intermittent high glucose exacerbates the aberrant production of adiponectin and resistin through mitochondrial superoxide overproduction in adipocytes. J Mol Endocrinol. 2010 Mar;44(3):179-85. doi: 10.1677/JME-09-0088.
Bergt C, Pennathur S, Fu X, Byun J, O'Brien K, McDonald TO, Singh P, Anantharamaiah GM, Chait A, Brunzell J, Geary RL, Oram JF, Heinecke JW. The myeloperoxidase product hypochlorous acid oxidizes HDL in the human artery wall and impairs ABCA1-dependent cholesterol transport. Proc Natl Acad Sci U S A. 2004 Aug 31;101(35):13032-7. Epub 2004 Aug 23.
Shao B, Pennathur S, Pagani I, Oda MN, Witztum JL, Oram JF, Heinecke JW. Modifying apolipoprotein A-I by malondialdehyde, but not by an array of other reactive carbonyls, blocks cholesterol efflux by the ABCA1 pathway. J Biol Chem. 2010 Jun 11;285(24):18473-84. doi: 10.1074/jbc.M110.118182. Epub 2010 Apr 8.
Vaisar T, Pennathur S, Green PS, Gharib SA, Hoofnagle AN, Cheung MC, Byun J, Vuletic S, Kassim S, Singh P, Chea H, Knopp RH, Brunzell J, Geary R, Chait A, Zhao XQ, Elkon K, Marcovina S, Ridker P, Oram JF, Heinecke JW. Shotgun proteomics implicates protease inhibition and complement activation in the antiinflammatory properties of HDL. J Clin Invest. 2007 Mar;117(3):746-56.
Green PS, Vaisar T, Pennathur S, Kulstad JJ, Moore AB, Marcovina S, Brunzell J, Knopp RH, Zhao XQ, Heinecke JW. Combined statin and niacin therapy remodels the high-density lipoprotein proteome. Circulation. 2008 Sep 16;118(12):1259-67. doi: 10.1161/CIRCULATIONAHA.108.770669. Epub 2008 Sep 2.
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Hirsch IB. Blood glucose monitoring technology: translating data into practice. Endocr Pract. 2004 Jan-Feb;10(1):67-76. Review.
Rodbard D. New and improved methods to characterize glycemic variability using continuous glucose monitoring. Diabetes Technol Ther. 2009 Sep;11(9):551-65. doi: 10.1089/dia.2009.0015.
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009 Aug;32(8):1378-83. doi: 10.2337/dc09-0108. Epub 2009 May 8.
Hirsch IB, Brownlee M. Beyond hemoglobin A1c--need for additional markers of risk for diabetic microvascular complications. JAMA. 2010 Jun 9;303(22):2291-2. doi: 10.1001/jama.2010.785.
Basevi V, Di Mario S, Morciano C, Nonino F, Magrini N. Comment on: American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care 2011;34(Suppl. 1):S11-S61. Diabetes Care. 2011 May;34(5):e53; author reply e54. doi: 10.2337/dc11-0174. Erratum in: Diabetes Care. 2011 Aug;34(8):1887.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff Probstfield, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01524705     History of Changes
Other Study ID Numbers: 42178-E/G
First Submitted: January 17, 2012
First Posted: February 2, 2012
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Jeff Probstfield, University of Washington:
Pilot Study
Prospective Randomized Trial
Comparative Effectiveness
Glycemic Variability
insulin glargine
exenatide
basal insulin
bolus insulin

Additional relevant MeSH terms:
Insulin, Globin Zinc
Exenatide
Insulin
Metformin
Insulin Glargine
Glucagon-Like Peptide 1
Glucagon
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents


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