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Clinical Trial NCT01524705 (FLAT-SUGAR) for Type 2 Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
University of WashingtonFLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR) Phase 4 102
FLAT-SUGAR: FLuctuATion Reduction With inSULin and Glp-1 Added togetheR
- FLAT-SUGAR
- 42178
Prospective Randomized Trial
Comparative Effectiveness
Glycemic Variability
insulin glargine
exenatide
basal insulin
bolus insulin
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalInsulin Glargine, metformin, exenatide Approximately 60 Type 2 diabetes mellitus (DM) participants will be instructed on an American Heart Association/American Diabetes Association (AHA/ADA) meal plan. Insulin Glargine, metformin and exenatide will used as a combination strategy to control individual glycosylated hemoglobin level (HbA1Cs) between 6.7 and 7.3% throughout the trial. The use of exenatide makes this the intervention arm | Insulin Glargine Glargine-injectable, variable, once daily (QD), 6 months Metformin Metformin-oral, up to 1000mg, twice daily (BID), 6 months Exenatide Injectable, 5mcg, twice daily (BID), 6 months |
Active Comparatorglargine, 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). The use of the short acting insulins make this the control arm | Insulin Glargine Glargine-injectable, variable, once daily (QD), 6 months Metformin Metformin-oral, up to 1000mg, twice daily (BID), 6 months Prandial insulin Aspart or glulisine or lispro |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline | The change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM) | At baseline, 6 months of intervention |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of Participants With Hypoglycemia | Severe hypoglycemia-documented glucose \<50mg/dl (participant journal), and hypoglycemic attacks requiring hospitalization, or treatment by emergency personnel. | 26 weeks |
Weight Change During Trial | Weight in kg at 26 weeks minus weight at baseline. | Baseline vs 26 weeks |
T2DM for >12 months defined according to current ADA criteria
C-peptide >0.5 ng/mL-after informed consent has been signed, samples will be drawn fasting and sent to a central lab
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)
HbA1c 7.5-8.5% for enrollment
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
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
Ability to speak & read English
- 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
- Cannot have had any cardiovascular event or interventional procedure, (MI, Stroke or revascularization) or been hospitalized for unstable angina within the last 3 months
- Inability or unwillingness to discontinue use of acetaminophen products during CGM use
- 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)
- Intolerance of metformin dose <500 mg/day
- Inability or unwillingness to perform blood glucose testing a minimum of 3 times/per day
- Creatinine level ≥1.5 for males or 1.4 for females
- ALT level ≥ 3 times upper limit of normal
- Current symptomatic heart failure, history of NYHA Class III or IV congestive heart failure at any time, or ejection fraction (by any method) < 25%
- Inpatient psychiatric treatment in the past 6 months
- Currently participating in an intervention trial
- Chronic inflammatory diseases, such as collagen vascular diseases or inflammatory bowel disease
- History of pancreatitis
- BMI >45kg/m2
- For females, pregnant or intending to become pregnant during the next 7 months
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