Change in Flow-mediated Dilation
| Group | Value (Percentage) | Spread |
|---|---|---|
| Liraglutide | 0.71 | 4.82 |
| Sitagliptin | 2.06 | 6.42 |
| Hypocaloric Diet | 1.24 | 5.09 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This project tests the principle hypothesis that stable glucagon like peptide-1 (GLP-1) analogues have specific GLP1R-dependent beneficial effects on vascular endothelial function, fibrinolysis and inflammation in obesity that exceed the benefits of weight loss, and that genetic or other individual factors that modulate GLP1R sensitivity can modify the effect of these analogues on cardiovascular risk.
Experimental
liraglutide
Subjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo.
Active comparator
sitagliptin
Subjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks.
Active comparator
hypocaloric diet
Subjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs.
Outcomes the sponsor listed as primary.
Change in Flow-mediated Dilation
Time frame · Baseline to 2 and 14 weeks
Brachial artery diameter is measured under basal conditions and during reactive hyperemia (Flow Mediated Dilation as %)
Urine Albumin-to-creatinine Ratio
Time frame · Baseline to 13 weeks
Ratio of urine albumin to creatinine in a spot urine collected after overnight rest
Change in Plasminogen Activator Inhibitor-1
Time frame · Baseline to 2 and 14 weeks
Plasma plasminogen activator inhibitor-1 antigen
Blood Pressure
Time frame · Baseline, and after 2 weeks and 14 weeks of treatment
The mean of three systolic blood pressure measurements one minute apart using a oscillometric recording device with patient in supine position
Heart Rate
Time frame · Baseline, and after 2 weeks and 14 weeks of treatment
The mean of three measurements with the patient in the supine position
Fasting Glucose
Time frame · Baseline, and after 2 weeks and 14 weeks of treatment
Blood glucose collected after overnight fast
Fasting Insulin
Time frame · Baseline, and after 2 weeks and 14 weeks of treatment
Plasma insulin collected after overnight fast
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage) | Spread |
|---|---|---|
| Liraglutide | 0.71 | 4.82 |
| Sitagliptin | 2.06 | 6.42 |
| Hypocaloric Diet | 1.24 | 5.09 |
| Group | Value (mg/g) | Spread |
|---|---|---|
| Liraglutide | 12.0 | 23.6 |
| Sitagliptin | 7.9 | 7.6 |
| Hypocaloric Diet | 6.3 | 3.8 |
| Group | Value (units/mL) | Spread |
|---|---|---|
| Liraglutide | -2.4 | 7.8 |
| Sitagliptin | -1.3 | 8.3 |
| Hypocaloric Diet | 1.1 | 6.9 |
| Group | Value (mmHg) | Spread |
|---|---|---|
| Liraglutide | 124.1 | 7.7 |
| Sitagliptin | 120.2 | 11.3 |
| Hypocaloric Diet | 127.7 | 8.3 |
| Group | Value (Beats per minute) | Spread |
|---|---|---|
| Liraglutide | 64.9 | 7.5 |
| Sitagliptin | 67.2 | 9.0 |
| Hypocaloric Diet | 63.8 | 8.8 |
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Liraglutide | 95.3 | 8.6 |
| Sitagliptin | 97.6 | 10.0 |
| Hypocaloric Diet | 94.5 | 12.0 |
| Group | Value (uU/mL) | Spread |
|---|---|---|
| Liraglutide | 22.7 | 16.8 |
| Sitagliptin | 23.3 | 14.4 |
| Hypocaloric Diet | 26.7 | 21.2 |
| Group | Value (kg) | Spread |
|---|---|---|
| Liraglutide | -2.72 | 3.44 |
| Sitagliptin | -0.71 | 2.12 |
| Hypocaloric Diet | -4.95 | 3.98 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LiraglutideSubjects in the liraglutide group will receive subcutaneous liraglutide (0.6 mg/d for one week, 1.2 mg/d for one week, and then 1.8 mg/d for 12 weeks) and oral placebo. Liraglutide: subcutaneous liraglutide daily Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39. Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment. | 0 / 46 | 0 / 46 | 26 / 46 |
| SitagliptinSubjects in the sitagliptin group will receive subcutaneous placebo daily and sitagliptin 100 mg/d orally for 14 weeks. Sitagliptin: oral sitagliptin daily Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39. Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment. | 0 / 23 | 1 / 23 | 6 / 23 |
| Hypocaloric DietSubjects in the hypocaloric diet group will be given a caloric goal designed to achieve a weight loss similar to that expected in the liraglutide treatment arm based on his or her resting energy expenditure. Subjects will be provided counseling and written instructions on how to achieve their daily caloric goal, including use of their own mobile phone applications to monitor caloric intake. To assure compliance with the prescribed caloric goal, subjects will meet with the study dietitian every other week for problem solving and review of diet intake logs. hypocaloric diet: Reduced calorie intake to achieve weight loss. Placebos: Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39. Exendin (9-39): All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment. | 0 / 24 | 1 / 24 | 6 / 24 |
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