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Inability to enroll due to the widespread use of both classes of drugs in patients with T2DM, including those on concomitant insulin therapy.
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The purpose of this study is to see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking insulin. This research study is being done to investigate which of these commonly-used medications, medication combinations or increasing insulin dose is better.
This is a single center prospective, randomized, placebo-controlled trial in overweight/obese patients with insulin treated uncontrolled type 2 diabetes
Eligible subjects willing to participate in the study will be randomized to one of 3 treatment groups:
Group 1: Insulin titration + behavioral therapy Basal insulin titration upto 12 weeks with 2 U increment every 3 days (Fasting glucose goal <110) based on self-monitored blood glucose.
After 12 weeks, patients with HbA1c >8% will switch to a basal bolus regimen.
Group 2: Exenatide-LAR 2mg q week x 24 weeks + Dapagliflozin placebo x 52 weeks + titrated basal insulin +behavioral therapy.
Group 3: Exenatide-LAR 2mg q week x 24 weeks plus Dapagliflozin 5mg QD x 2 weeks followed by 10mg QD x22 weeks +titrated basal insulin + behavioral therapy.
Behavioral therapy will be delivered by registered dietitians and will include the BMIQ program -a web based medical weight loss program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Insulin titration and behavioral therapy. |
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| Group 2 | Placebo Comparator | Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy. |
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| Group 3 | Experimental | Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide-LAR plus Dapagliflozin placebo | Drug | Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | To determine the efficacy of Exenatide-LAR and Exenatide-LAR plus dapagliflozin in lowering HbA1c compared with insulin titration in obese, insulin treated subjects with uncontrolled Type 2 Diabetes Mellitus at 24 weeks | baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on body weight in obese, insulin treated subjects with uncontrolled T2DM | baseline, 24 weeks |
| Change in waist circumference |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alpana P Shukla, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Weight Control Center | New York | New York | 10065 | United States |
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| Exenatide-LAR plus Dapagliflozin | Drug | Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin 5 mg x 2 weeks, then 10 mg for 22 weeks and behavioral therapy. |
|
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| Insulin Titration | Drug | Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8% |
|
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| Behavioral Therapy | Behavioral | Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program. |
|
To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on waist circumference in obese, insulin treated subjects with uncontrolled T2DM
| baseline, 24 weeks |
| Change in fasting glucose | To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on fasting glucose (FG) in obese, insulin treated subjects with uncontrolled T2DM | baseline, 24 weeks |
| Change in fasting lipids | To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on fasting lipids in obese, insulin treated subjects with uncontrolled T2DM | baseline, 24 weeks |
| Change in blood pressure | To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on blood pressure in obese, insulin treated subjects with uncontrolled T2DM | baseline, 24 weeks |
| Change in total dose insulin | To determine the effect of Exenatide-LAR and Exenatide-LAR plus dapagliflozin vs insulin titration on total dose insulin in obese, insulin treated subjects with uncontrolled T2DM | baseline, 24 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| C529054 | dapagliflozin |
| D000069036 | Insulin Glargine |
| D000069057 | Insulin Detemir |
| D061267 | Insulin Aspart |
| D061268 | Insulin Lispro |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D061266 | Insulin, Short-Acting |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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